[c09aa8]: / clusters / 9knumclustersv2 / clust_2110.txt

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The patient must be willing to undergo a biopsy prior to treatment
The patient must be willing to undergo repeat biopsy at week (for the first patients in the phase part of the study)
Patients with cutaneous or superficial lesions that do not require imaging guidance for biopsy must be willing to undergo biopsies for tissue submission and blood draws for translational medicine
For the expansion portion of the study: patients must have tissue that is amenable to biopsy and must be willing to undergo research biopsy; patients who undergo an attempted research biopsy procedure for the purpose of this protocol, and in whom inadequate tissue is obtained, are not required to undergo a repeat biopsy in order to continue on protocol
Willingness to undergo serial tumor biopsies before and on treatment
Cohort A Dose Expansion (Ribociclib + PDR): Participants with accessible tumor lesion(s) must be willing to undergo two research biopsies: one prior to treatment initiation and one after weeks of protocol therapy; participants who undergo an attempted on-treatment research biopsy and in whom inadequate tissue is obtained are still eligible to receive protocol therapy; they will not be required to undergo a repeat research biopsy attempt
Expansion Cohort B (Ribociclib + PDR + Fulvestrant): Participants with accessible tumor lesion(s) must be willing to undergo two research biopsies: one prior to treatment initiation and one after weeks of protocol therapy; participants who undergo an attempted on-treatment research biopsy and in whom inadequate tissue is obtained are still eligible to receive protocol therapy; they will not be required to undergo a repeat research biopsy attempt
Willingness to provide archival tumor samples; if sample is not available, a biopsy should be considered in patients with safely accessible disease; participants who undergo an attempted research biopsy procedure for the purpose of this protocol, and in whom inadequate tissue is obtained, are not required to undergo repeat biopsy in order to continue on protocol
Subjects enrolling to the phase portion of the trial who have received a prior RET TKI must be able and willing to undergo a pre-treatment fresh tumor biopsy
Subjects enrolling to cohort B or C of the phase portion of the trial who have received a prior RET TKI must be able and willing to undergo a pre-treatment fresh tumor biopsy
Availability of a cancerous lesion amenable to biopsy and willing to undergo a pre-treatment biopsy
Participants enrolling in the dose expansion must have tissue that is amenable to biopsy and be willing to undergo a fresh tissue biopsy at baseline; participants who undergo an attempted research biopsy procedure for the purpose of this protocol, and in whom inadequate tissue is obtained, are not required to undergo a repeat biopsy in order to continue on protocol
Phase only: Willing to consent to mandatory pre-treatment and on-treatment tumor biopsy
Willing and able to undergo a pre- and subsequent on-treatment bone marrow biopsies
Patient is willing to undergo a fresh tumor biopsy (core or excisional) for correlative analyses (ie. PD-L expression)
Subjects must agree to undergo tumor biopsies until biopsies have been obtained from subjects (i.e., biopsies are required in at least the first enrolled subjects, or until a goal of study biopsies are obtained); subjects in whom a biopsy is technically not feasible or in whom would result in unacceptable risk in the opinion of the investigator, may be exempted from the biopsy requirement with discussion with the principal investigator
Biopsies:\r\n* Cohorts B and C: all patients with disease that is deemed by the treating investigator as safely accessible to biopsy are required to undergo research biopsies as outlined in this protocol\r\n* Cohort A: such biopsies are optional
Parts H, and I: Must be able and willing to undergo mandatory tumor biopsies prior to study treatment and at the time of discontinuation from study treatment.
Participants must be willing to undergo a research biopsy at baseline and at cycle day if extracranial metastases are safely accessible. Participants for whom biopsies cannot be safely performed must be willing to submit an archival primary and/or metastatic specimen. The biopsies may be waived with prior principal investigator (PI) approval for the first participants enrolled to the safety run in phase
Participants must be able and willing to undergo a pre-treatment tumor tissue biopsy; participants must also be willing to undergo an on-treatment tumor tissue biopsy if clinically feasible
Must be able and willing to undergo mandatory tumor biopsy.
Agrees to undergo a pretreatment and a post-treatment biopsy.
Is willing to undergo a mandatory pre-treatment research biopsy
Participants must be willing and able to undergo a biopsy at the start of this study and an on-treatment biopsy if safe and feasible
All patients with biopsy-accessible disease must be willing to undergo paired research biopsies; these biopsies will occur - hours after the cycle (C) day (D) cisplatin dose (i.e. CD or CD) and - hours (hrs) (+/- hrs) after the last dose of AZD on CD; the exact timing of the biopsy relative to receipt of study treatment should be accurately recorded\r\n* Biopsies may be done with local anesthesia or intravenous conscious sedation, according to standard institutional guidelines\r\n* Research biopsies requiring general anesthesia are not allowed on this protocol unless a biopsy is being obtained simultaneously for clinical reasons, in the judgment of the patients treating physician\r\n* Patients who undergo an attempted on-treatment research biopsy and in whom inadequate tissue is obtained are still eligible to continue protocol therapy; they will not be required to undergo a repeat biopsy attempt\r\n* If dosing is delayed placing the biopsy outside of the allowable window, the biopsy should be rescheduled to be within the window; if not feasible, the biopsy should be obtained as close to within the window as possible\r\n* Fine needle aspirates (FNA) is not allowed
The participant must be willing to undergo the three required research biopsies over the course of protocol therapy; participants who undergo an attempted research biopsy procedure for the purpose of this protocol, and in whom inadequate tissue is obtained, are not required to undergo a repeat biopsy in order to continue on protocol
Patient must be willing to undergo breast biopsies as required by the study protocol.
Participants enrolling to the NTRK cohort who have received treatment with a prior NTRK inhibitor must be able and willing to undergo a baseline tumor biopsy
Participants enrolling to the HR or replicative stress cohorts during stage must have disease that is amenable to biopsy and be willing to undergo a pre-treatment tumor biopsy.
Phase I: Patients with a site of disease amenable to biopsy, and willing to undergo a new tumor biopsy at screening, and during treatment.
Must have measurable disease by RECIST v., a successful pre-treatment tumor biopsy, and be willing to undergo tumor biopsy during treatment
Part A and Part B: Must be willing to undergo pretreatment and on-treatment core needle or excisional tumor biopsies.
Patients must be willing and able to undergo study required biopsies.
Patients enrolled in the expansion phase must be willing to undergo pre and post-Cycle biopsies.
Patients must have a PN amenable to a percutaneous biopsy to participate in the biopsy portion of this study, and must be willing to undergo pre-, and on treatment tumor biopsies; there should be no contraindication for serial biopsies; NOTE: up to patients who meet all criteria, but have PN which cannot be biopsied safely, will be eligible for the treatment portion of the study
Willingness to be evaluated for surgical placement of an intraperitoneal port and undergo biopsy if feasible for a research sample
Willingness to undergo a tumor biopsy at baseline and at disease progression
Patients enrolling in the expansion cohorts must have disease amenable to biopsy and be willing to undergo pre-and post-treatment biopsies
Patient must agree, as part of the informed consent, to provide blood and archived tumor samples for molecular correlates, pharmacokinetics and pharmacodynamics; patients in the expansion cohort A must have tumor sites that are accessible for tumor biopsy and must agree to undergo a pre-treatment and post-treatment biopsy; patients in cohort B group and must have tumor sites that are accessible for tumor biopsy and must agree to undergo a pre-treatment and post-treatment biopsy; this requirement may be waived after discussion with the principal investigator as long as a minimum of patients in cohort B group and patients in cohort B group are able to undergo the required biopsies
Participant must be willing to undergo a pre-treatment screening biopsy for enrollment and subsequent biomarker analyses.
Participants must be willing to undergo one mandatory on-study tumor biopsy following a week, single cycle induction treatment of olaparib. A second on-study biopsy at time of disease progression is optional, but not mandatory.
Willingness and ability to undergo mandatory tumor biopsy at baseline
Willingness and ability to undergo mandatory whole blood sample collections at baseline
Willing to undergo mandatory biopsy at screening and on treatment. Part A only: the first subjects in each cohort are exempt from this requirement.
Subjects must be willing to undergo a biopsy for assessment of clinical response.
COHORT : HORMONE RECEPTOR POSITIVE BREAST CANCER: Patients must have at least one lesion deemed safe to biopsy and be willing to undergo mandatory biopsies
COHORT : ENDOMETRIAL CANCER: Patients must have at least one lesion deemed safe to biopsy and be willing to undergo mandatory biopsies
Must be agreeable to the mandatory research tumor biopsies (pre-treatment and on-treatment); tumor biopsies are mandatory at pre-treatment and at on-treatment; there is an optional biopsy at post-progression
Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers
Willing to undergo a new core or excisional biopsy from a metastatic, not previously irradiated tumor lesion during screening
Participants must agree to undergo a research biopsy, if tumor is safely accessible, at baseline and within days prior to course day (CD); participants for whom newly-obtained samples cannot be provided (e.g. inaccessible or participant safety concern) may submit an archived specimen\r\n* Note: After the first participants undergo biopsy on cabozantinib, we will review their adverse event profiles to ensure no more than a % rate of grade or higher bleeding or wound healing complications occur; if more than patients (> %) have safety concerns, we will reassess the safety of collecting the research biopsies; full review of all grade (including grade and ) may also prompt changes and will be reviewed by the study team; Exelixis may be consulted if necessary
Patients must have at least one tumor amenable to serial biopsy in clinic or be willing to undergo serial biopsies through image-guided procedures during the neoadjuvant phase of the protocol. Patients must be willing to provide tumor samples at the time points.
In dose expansion, patients must be willing to undergo a pre-treatment biopsy, and four research PET imaging techniques (C-Glutamine and F-FSPG), two pre-treatment and two after one cycle of treatment
For the Western safety cohort only: willingness to undergo serial skin tissue biopsies.
Willingness to undergo a fresh tumor biopsy pre-treatment and on treatment, if deemed safe and feasible by treating oncologist.
Patients who are willing and able to comply with the protocol and study procedures including willingness to undergo tumor biopsy or paracentesis for tumor cells before therapy (at baseline) and after initiation of treatment (before cycle ) for all subjects if this is clinically and safely feasible to do so
Willingness to undergo research biopsy
The subject has biopsy accessible tumor and is willing to undergo biopsy prior to planned protocol treatment
Patient must be willing to undergo two biopsies- before and on-treatment, provided the procedure is not deemed high-risk and is clinically feasible
Participants must have disease amenable to and be willing to undergo serial core or excisional biopsies of a tumor lesion(s)
Patients with tumor that is felt to be accessible to biopsy must be willing to provide tissue from a newly obtained core biopsy of a tumor lesion at baseline; biopsies will be obtained up to week ( days) prior to initiation of treatment on cycle , day ; patients who undergo an attempted research biopsy procedure for the purpose of this protocol, and in whom inadequate tissue is obtained, are not required to undergo a repeat biopsy in order to continue on protocol
Subjects must be willing to undergo a preliminary biopsy of a metastatic focus for research purposes; a second post-treatment biopsy will be offered but will not be mandated
Willingness to undergo paired tumour biopsies during the trial.
Be willing to undergo normal skin biopsy prior to initiation of treatment and after treatment
Is medically able and willing to undergo needle biopsy of a tumor lesion; PD-L expression is not required to enroll in the trial
Willing to undergo core biopsies for research at study entry and at ~ weeks
Willingness to undergo core biopsy of primary hepatic tumor prior at baseline and again at cycle day
PHASE II: Patients must have measurable disease according to RECIST . criteria that is amenable to biopsy and be willing to undergo pre- and post-treatment tumor biopsies; lesions to be biopsied do not have to be those used for measurement
Willing to undergo a biopsy of a metastatic site of breast disease for central laboratory determination of ER and correlative research purposes
mCRPC EXPANSION COHORT: All patients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy
Be willing to undergo tissue biopsies as mandatory as per protocol for patients with biopsy accessible disease
Cohort Expansion: Able and willing to give valid written consent to undergo a new tumour biopsy (prior to study treatment). Able and willing to undergo a second tumour biopsy on treatment. Where possible, tumour lesions used for new biopsies should not be the same lesions used as RECIST target lesions, unless there are no other lesions suitable for biopsy. Archival samples may be required if there is inadequate tissue in the biopsy specimen.
Consent to undergo a fresh biopsy in case of benefit from therapy and subsequent progression
Patients must be willing and able to undergo biopsy according to the institutes own guidelines and requirements for such procedures
Note: Subjects who are unable to undergo pre-dose (screening biopsy) will not be eligible
Willingness to provide informed consent to undergo pre- and post-dose biopsy
All participants will be required to undergo mandatory pre and on-treatment biopsies
Must undergo a new tumor biopsy for acquisition of resistant tumor tissue; subjects unable to undergo a new tumor biopsy are not eligible for Part B
The subject must agree to undergo the pre- and post-treatment research biopsies if a non-osseous metastatic site is available for biopsy; the pre-treatment biopsy will be standard of care, and used for diagnostic purposes to assess ER/ progesterone receptor (PgR) / HER status and confirm the presence of breast tumor cells; the post-treatment (day ) biopsy will be performed for research purposes; both the pre- and post-treatment biopsies will be assessed on-site by a pathologist by touch-prep to ensure that the biopsied tissue contains tumor cells
Patients must be willing to undergo tumor biopsies
Willingness to undergo a pre-treatment and on-treatment tumor biopsy to obtain the specimen.
Willingness to undergo a tumor biopsy prior to treatment.
Willingness to undergo a tumor biopsy while on study treatment.
Willing to undergo biopsy of a metastatic lesion at the time of progression
Patients whose clinical biopsies are found to be insufficient for the planned translational studies must be willing to undergo a research biopsy.
Patients must be willing to undergo HIFU, CEUS, MRI and prostate biopsy pre-RP for research purposes
Subjects in expansion cohort only: Willing to undergo pre- and on-treatment biopsies
Willingness to undergo fluoroscopy-guided SGB or sham treatment
Willing to undergo pharmacogenetic testing
Subjects must agree to undergo two research-directed biopsies during treatment
Phase only: Willing to consent to mandatory pre-treatment and on-treatment tumor biopsy
Willing to undergo tumor biopsies from injected and distal lesions
Presence of biopsiable disease and patient able to undergo pre-treatment and on-treatment biopsy
Subjects who are willing and able to comply with the protocol and study procedures including willingness to undergo tumor biopsy for tumor cells before therapy at cycle , day , and day (before cisplatin dose) if this is clinically and safely feasible to do so
Subjects must be willing to undergo sets of core needle biopsies (pre-treatment and on-treatment), if there are lesions amenable to biopsy; an optional core biopsy will be requested at progression
Patients must be willing to undergo tumor biopsies
Ability to undergo up to minutes of PEM imaging
Patient must be willing to undergo mandatory research biopsy and blood draw; prior to biopsy procedures patients must be able to be off medications that could increase the risk of bleeding
Ability and willingness to undergo repeat tumor biopsies (the biopsy is optional and only applicable to subjects considered for the expansion cohort stage of the study)
Subjects enrolling in the primary refractory or relapsed melanoma must be willing to undergo mandatory pretreatment and on-treatment biopsies.
Must be willing to undergo tumor biopsy at study entry for biologic correlates.
If patient > years, must be willing to undergo on-treatment tumor biopsy unless medically contra-indicated
Willingness to undergo a pretreatment and on-treatment tumor biopsy to obtain tumor tissue.
. Subject who is willing and able to undergo biopsy.
Subject must undergo mandatory biopsies, including one pretreatment and one post treatment tumor biopsy procedure
Subject must agree to undergo two research-directed biopsies during treatment
Willing to undergo breast core biopsies as required by the study protocol
Subject is willing and able to undergo biopsy.
Willingness to undergo a tumor biopsy
Availability of archival (diagnostic) specimens and willing to undergo a pre-treatment biopsy.
Participants must have biopsiable disease and be willing to undergo pre-treatment biopsy, or have an archival tumor sample obtained < months prior to study entry
Willing to undergo endoscopic evaluation with biopsies in compliance with this protocol
Presence of biopsiable disease and willingness to undergo pre-treatment biopsy
Subjects should be willing to undergo a research related biopsy prior to treatment and at the time of progression
Willingness to undergo a tetanus vaccination
Willingness to undergo pre- and on-treatment biopsies unless not clinically feasible while on treatment
Willingness to undergo a research biopsy of the affected breast\r\n* Biopsies may be done with local anesthesia or intravenous conscious sedation, according to standard institutional guidelines\r\n* If a biopsy requires general anesthesia, then it is not allowed on this protocol\r\n* Patients who undergo a research biopsy procedure for the purpose of this protocol, and in whom inadequate tissue is obtained, are still eligible and are not required to undergo a repeat biopsy in order to enter the study\r\n* Some patients may have had a clinically indicated biopsy upon recent disease progression and agreed to submit tissue to their institutions frozen tumor bank; if the tissue was processed as specified in this protocol, no additional pre-treatment biopsy is required as that specimen can be used for the purposes of participation in this clinical trial
Willing to undergo biopsy for research purposes only; Note: if possible, the pre-treatment biopsy should be performed after all other eligibility criteria are confirmed
For patients with biopsy-accessible disease, patients must be willing to undergo a required on-treatment research biopsy; this biopsy will occur on cycle day ;\r\n* Biopsies may be done with local anesthesia or intravenous conscious sedation, according to standard institutional guidelines\r\n* Research biopsies requiring general anesthesia are not allowed on this protocol unless a biopsy is being obtained simultaneously for clinical reasons, in the judgment of the patients treating physician\r\n* Patients who undergo an attempted on-treatment research biopsy and in whom inadequate tissue is obtained are still eligible to continue protocol therapy; they will not be required to undergo a repeat biopsy attempt
Willingness to undergo tumor biopsy
The subject has biopsy accessible tumor and is willing to undergo biopsy prior to planned protocol treatment
Tumor tissue requirements: Availability of archival tissue, or willingness to undergo fresh biopsy at baseline; Enrollment in PK/PD cohort may be limited to subjects with disease amenable to pre- and post-dose biopsies, and willingness to undergo biopsy.
Patients may undergo an optional biopsy of the metastatic disease at baseline and after cycles of BIBF-
If an open biopsy is performed, the patient must be at least one week post biopsy; this requirement does not apply to patients who undergo stereotactic biopsies
Patients on stage of the enrollment must have tumor sites that are easily biopsied and be willing to undergo pre- and post-treatment (around day +/- days) tumor biopsies
Patients on the Phase II portion only must be willing to undergo pre- and post-treatment biopsies and have at least one lesion amenable to biopsy
Willingness to undergo pre-treatment and on-treatment biopsy.
Willingness to undergo two tumor biopsies: before and after administration of RO.
Study patients must have disease that is amenable to pre and post treatment biopsy and be willing to undergo this
Willing to undergo pre-treatment lesion biopsy and post-treatment lesion biopsy
Patients may choose to undergo an optional tumor biopsy including collection of research blood samples pretreatment and at weeks and
If the maximum number of non-biopsy subjects has accrued to the study, willingness to undergo tumor biopsies. NOTE: Tumor biopsies may be required, depending on the number of subjects who have agreed to undergo correlative studies.
Patients must have biopsy accessible disease and must be willing and able to undergo a biopsy
Participants with accessible disease must be willing to undergo a research biopsy before beginning crossover therapy
Willing to undergo tumor biopsy
If an open biopsy is performed, the patient must be at least one week post biopsy; this requirement does not apply to patients who undergo stereotactic biopsies
Are to undergo laparotomy
Patients unable to undergo routine endoscopy with biopsy
Willingness to undergo tumor biopsy prior to initiation of treatment
Patients must be willing to undergo mandatory research biopsy
Patients must be willing to undergo mandatory research biopsy
Patients cannot undergo CT examination.
Patients who are planning to undergo treatment in a different institution
Willingness to undergo biopsy
Patients who cannot undergo MRIs
Patients must be willing to undergo a radiologic imaging before and after biopsy of the prostate
Patients must be willing to undergo a biopsy of the prostate
If planning therapeutic systemic therapy, willing to undergo biopsy for research purposes only after drug dosing in LCCC
Fit to undergo all procedures listed in protocol
Unfit to undergo any procedures listed in protocol
Willing to undergo baseline and posttreatment tumor biopsy procedure.
Willing to undergo two mandatory core biopsies after diagnosis to obtain tissue for correlative studies; the third biopsy time point is optional
Subjects must have a tumor lesion that is amenable to an image-guided core biopsy and willingness to undergo two biopsies (baseline and weeks after first dose of study treatment).
Tumor amenable to biopsy and willingness to undergo tumor biopsies before and after M (VX-) treatment during the expansion phase of the trial (biopsies optional during the escalation phase)
During the expansion phase of the protocol, patients must have disease amenable to biopsy and be willing to undergo pre- and post-treatment biopsies