[c09aa8]: / clusters / 9knumclustersv2 / clust_2392.txt

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Evidence that tumor is adherent to or invading the mesorectal fascia on imaging studies such that the surgeon would not be able to perform an R resection (one with negative margins)
Absolute neutrophil count >= /uL; Note: no transfusions are permitted days prior to laboratory studies to determine eligibility
Patients enrolled in any other clinical studies the investigator believes to be in conflict with this investigation
All radiology studies (study requiring staging) must be performed within days prior to the start of therapy
Patients must be able to undergo appropriate imaging studies to monitor tumor response
Patient must consent to provision of a sample of blood in order that the specific correlative marker assays (Correlative Studies) may be conducted.
Diagnostic or laboratory studies performed exclusively to determine eligibility for this trial must only be done after obtaining written informed consent from all patients, which can be accomplished using the NCI, POB screening protocol; studies or procedures that were performed for clinical indications (not exclusively to determine eligibility) may be used for screening or baseline values even if the studies were done before informed consent was obtained, if the patient agrees
History of previous enrollment in Studies NCT or NCT.
INTRATUMORAL STUDIES PATIENTS:
Patients consent to MRI studies at - week intervals until evidence of tumor regression on at least imaging studies. In no case, will the interval between MRI studies be longer than months. MRI study may be introduced at any time should the patients develop new or clearly worsening symptoms and/or introduction of steroids
Has known metastatic disease as determined by conventional staging studies.
Patients must agree to tissue collection for correlative studies at the specified timepoints.
Subjects in concurrent studies can only be enrolled with permission from Medtronic. Please contact Medtronic's study manager to determine if the subject can be enrolled in both studies.
have metastatic disease evaluable on imaging studies;
Pre-treatment biopsy must establish the diagnosis AND have enough remaining tissues to satisfy the mandatory research studies
Subjects may not have had prior systemic chemotherapy regimens administered for treatment of their current breast cancer; however, studies (window studies, for example) that are deemed non-therapeutic, including those that utilize agents that are not Food and Drug Administration (FDA) approved for the treatment of the patients current breast cancer, are permitted
Patients consent to MRI studies at - week intervals until evidence of tumor regression on at least imaging studies. In no case, will the interval between MRI studies be longer than months. MRI study may be introduced at any time should the patients develop new or clearly worsening symptoms and/or introduction of steroids
Plan to proceed to surgery following peri-operative chemotherapy based on standard staging studies per local practice
Diagnostic or laboratory studies performed exclusively to determine eligibility for this trial must only be done after obtaining written informed consent from all patients, which can be accomplished using the study specific informed consent or another consent, such as the National Cancer Institute (NCI), Pediatric Oncology Branch (POB) screening protocol; studies or procedures that were performed for clinical indications (not exclusively to determine eligibility) may be used for screening or baseline values even if the studies were done before informed consent was obtained, if the patient agrees
Presence of radiologically documented disease; all radiology studies must be performed within days prior to registration
Patients must agree to tissue collection for correlative studies (including participation in PA- and PA- for MD Anderson participants) at the specified timepoints
All laboratory and imaging studies must be completed and satisfactory within days of signing the consent document, with the exceptions of: negative serum pregnancy test for women of child-bearing potential that must be negative within days of screening for the trial, pulmonary function tests and/or cardiac stress tests whose results are valid for months if performed previously, unless there is an interval change in the patients clinical status determined by the Moffitt treating physician
Localized EAC and its baseline clinical stage determined as: T-TN or T-N positive (+); imaging studies suspicious for metastases must be followed with a negative biopsy before a patient can enter the study
Absence of abnormal lymphadenopathy suggesting metastatic PTC on physical examination and/or imaging studies
Willingness to donate blood for biomarker studies related to the type of therapies used in this trial and the tumor types being treated
Imaging studies show evidence of recurrent tumor(s); if a patient is going to be enrolled to dose level two or higher, the patient must have a component of supratentorial disease (so as to enable placement of a Rickham reservoir/catheter) that is amenable to resection or biopsy
Childs B or C cirrhosis or with evidence of severe portal hypertension by history, endoscopy or radiologic studies
Evidence of metastatic disease on imaging studies performed at the discretion of their physician
Able to comply with the protocol, including tissue sampling, imaging studies and surgical intervention
Patients with untreated positive blood cultures or progressive infections as assessed by radiographic studies
Inability to comply with protocol requirements, including pharmacokinetic (PK) studies (phase I only) and genetic studies
All pre-study and follow-up imaging studies preferably performed at City of Hope
No focal wall motion abnormalities as determined by either of the above studies
Subjects cannot be simultaneously enrolled on other treatment studies
Female patients who are pregnant are ineligible due to risks of fetal and teratogenic adverse events as seen in animal/human studies
Treatment within days prior to enrollment with another investigational device or drug (interventional clinical study / studies). Other investigational procedures while participating in this study are excluded (observational studies are permitted).
Transporter studies (in vitro) have shown that AZD is an inhibitor of breast cancer resistance protein (BCRP)
Participation in other investigational studies while enrolled on this trial.
PHASE II: The patient is participating in the trial at an institutional which has agreed to perform the imaging research studies, completed the American College of Radiation Imaging Network (ACRIN) defined scanner qualification procedures and received ACRIN approval
PHASE II: The patient has consented in writing to participate in one of the imaging research studies
Note: optional tumor biopsies (punch, fine needle aspiration [FNA], core or excisional) at pre-treatment, week , and at progression will be presented to subjects considering this study; we anticipate approximately - patients per cohort to have tumors biopsied for correlative studies; the additional subjects at the recommended phase II dose (RPD) (expansion cohort) are required to have correlative studies (blood collection and tumor biopsies at the defined time points)
Willingness to provide mandatory blood samples for pazopanib drug level assessments required for dosage adjustments, as well as for required pharmacogenomic studies
Patients must agree to participate in the translational medicine studies
Subject participating in studies involving approved drug or device will be enrolled only following a mutual consideration of the investigator together with the Sponsor.
Concurrent participation in other studies that could affect the primary endpoint
Tumor tissue for correlative studies is mandatory
Subjects must consent to bank whole blood, serum, plasma for future unspecified studies.
Institutions must offer patients the opportunity to submit tissue for future correlative studies
All necessary baseline studies for determining eligibility must be obtained within days prior to enrollment
Enrollment in other studies for any disease in the past days
Presence of < % blasts on hematologic studies
Patients who are simultaneously enrolled in other treatment studies
Participation in concurrent investigational studies
No available tumor material for correlative studies
Treatment with BT in previous studies
Subjects with extensive intraductal component and other characteristics not well visualized by imaging studies
Imaging studies documenting the response to first-line therapy must be available for evaluation by the investigator.
Patient is willing to have two biopsies while on treatment for correlative studies
Willingness to provide blood samples for immune studies, per study calendar, up to one year after study, even if off study
All necessary baseline studies for determining eligibility must be obtained within days of registration unless otherwise stated
Evidence of CRPC indicated by history of progression despite standard hormonal therapy (by PSA and/or imaging studies)
Subjects, who participated in previous ARQ studies that have reached their designated end-dates, who did not meet discontinuation criteria in their original study, and who may, in the opinion of the Investigator and the Sponsor, benefit from treatment
participation in other investigational studies, unless approved in writing by the study sponsor.
Women with and without prior therapy are also eligible; priority will be given to those who consent to participating in the pharmacokinetic studies
All studies required for evaluation will be performed within weeks of Photofrin administration
Ability and availability to complete all prescribed biomarker studies (Screening and after Cycle ).
Willingness to provide biologic samples for PIKCA sequencing and correlative studies
Evidence of measurable disease based on imaging studies within days before the first dose of study drug
Patients must agree to provide all imaging studies for central radiology review; this central radiology review may be performed retrospectively and will not be utilized for decision making for patients on study
Is participating in or has participated in other investigational interventional studies within the last days prior to study treatment
Diagnostic or laboratory studies performed exclusively to determine eligibility for this trial must only be done after obtaining written informed consent from all patients or their legal guardians (if the patient is < years old); when appropriate, pediatric patients will be included in all discussions; this can be accomplished through one of the following mechanisms: a) the NCI, POB screening protocol, b) an Institutional Review Board (IRB)-approved institutional screening protocol or c) the study-specific protocol; documentation of the informed consent for screening will be maintained in the patients research chart; studies or procedures that were performed for clinical indications (not exclusively to determine eligibility) may be used for baseline values even if the studies were done before informed consent was obtained
Subjects who participated in therapeutic adjuvant ovarian cancer studies are excluded except for platinum-based adjuvant studies
Ability to understand and the willingness to sign a written informed consent document; as the correlative studies are critical to the clinical and scientific value of the trial, CD count/HIV viral load determinations will be required, and participation in the tumor-based correlative studies will be strongly recommended; additionally, investigators MUST request sample donation to the AIDS Cancer Specimen Resource (ACSR); however, the patient may refuse sample donation; patients accrued to the expansion phase of the study will be required to undergo pharmacokinetic sampling
All patients or their legal guardians (if the patient is < years old) must sign a document of informed consent (screening protocol) prior to performing studies to determine patient eligibility; after confirmation of patient eligibility all patients or their legal guardians must sign the protocol specific informed consent to document their understanding of the investigational nature and the risks of this study before any protocol related studies are performed (other than the studies which were performed to determine patient eligibility) (Cohort )
Because significant time will have elapsed between apheresis/tumor biopsy and the initiation of immunotherapy, all patients or their legal guardians (if the patient is < years old) must sign a second informed consent to document their understanding of the investigational nature and the risks of this study before any protocol related studies are performed (other than the studies which were performed to determine patient eligibility)
All patients or their legal guardians (if the patient is < years old) must sign a document of informed consent (screening protocol) prior to performing studies to determine patient eligibility; after confirmation of patient eligibility all patients or their legal guardians must sign the protocol specific informed consent to document their understanding of the investigational nature and the risks of this study before any protocol related studies are performed (other than the studies which were performed to determine patient eligibility)
Concurrent enrollment on other clinical research studies that contain an interventional therapy is not permitted while subjects are receiving pasireotide or within half lives of finishing pasireotide; however, subjects may concurrently enroll in non-interventional studies (e.g. biobanking, mobile health tracking)
Patients enrolled in other CGA studies will not be excluded
Report severe depressive mood (Center for Epidemiological Studies Depression Scale [CES-D] > )
Current participation in a trial with another investigational agent, unless co-enrollment is approved by the principal investigators (PIs) of both studies
Patients who are pregnant or nursing; to date, no fetal studies in animals or humans have been performed; the possibility of harm to a fetus is likely
Patient with Rheumatoid Arthritis and other inflammatory diseases that would impact the correlative studies
Obtains a score of > on the shortened Center for Epidemiologic Studies - Depression (CES-D)
Prior participation in clinical studies that include durvalumab alone or in combination, where the study has registrational intent and the analyses for the primary endpoint have not yet been completed
Concurrent participation in other investigational studies allowed
Disease response must be confirmed with repeat laboratory studies at least days apart
Subjects may co-enroll on other investigational studies except for investigational studies whose primary aim is the prevention of GVHD
No exclusion is necessary based on the use of other concomitant medications; specifically there is no prohibition of concomitant antibiotic, antiviral or antifungal therapy; subjects may co-enroll on other investigational studies except for investigational studies whose primary aim is the prevention of GVHD
Concurrent participation in other experimental studies that could affect the primary endpoint
Tumor imaging studies including
All clinical and laboratory studies for organ functions to determine eligibility must be performed within days prior to enrollment unless otherwise indicated below.
Patients may enroll simultaneously on this study and other studies, including but not limited to NSABP B
Participation in more than research studies in the past months.
Consent to be contacted for future studies
Patients who do not consent for PK studies to be performed (alternatively: patients who initially consent to be on study but withdraws consent for PK study will be taken off study and replaced)
Both Studies:
Subject has concurrent participation in any interventional studies within days of first dose of study drug.
Consent to be contacted for future studies
The patient is participating in the trial at an institution which has agreed to perform the imaging research studies, completed the ECOG-American College of Radiology Imaging Network (ACRIN) defined scanner qualification procedures and received ECOG-ACRIN (or current ACRIN) approval
The patient is participating in the trial at an institution which has agreed to perform the imaging research studies, completed the ECOG-American College of Radiology Imaging Network (ACRIN) defined scanner qualification procedures and received ECOG-ACRIN approval as outlined
Patients presenting to surgery clinic after receipt of NAC at outside hospital with documentation of cT or cN/ disease on initial outside physical exam and imaging studies
Subjects with significant concurrent medical complications that in the judgment of the principal investigator(s) could affect the patient's ability to complete the planned trial, including the multiple imaging studies
Enrolled in any other clinical studies the investigator believes to be in conflict with this investigation
Tumor judged to be suitable for open cranial resection based on preoperative imaging studies
Subjects who are pregnant or lactating; subjects will be co-enrolled in this study and UPCC and therefore must comply with the UPCC requirements pertaining to pregnancy, lactation, conception and contraception use throughout their participation in both studies
Baseline MRI studies for participants receiving ferumoxytol must be performed within weeks of study entry
MRI has been performed in Step , and additional imaging studies and biopsies performed if indicated
Patient may be part of other clinical trials (as long as no other local treatments beyond GK such as WBRT or other local therapy are indicated to the brain) or imaging studies
Plans to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice.
Patients who will have surgical resections must consent to the use of post-surgery tumor samples for correlative molecular studies
Baseline creatinine (necessary for imaging studies)
Pre-imaging radiological scans/studies must be performed approximately weeks prior to study entry; but not less than hours prior
Laboratory studies must be completed within days prior to pimonidazole administration
Required imaging studies obtained within four weeks prior to registration
Clinical evidence of T-N-, T-N disease; this can be either by imaging studies or by physical exam findings
Able to undergo experimental imaging studies, as well as conventional bone and body imaging
Tumor judged to be suitable for open cranial resection based on preoperative imaging studies
The SunCoast Community Clinical Oncology Program (CCOP) Research Base does not exclude patients who are participating in other investigational studies; refer to the local Institutional Review Board (IRB) guidelines
Only subjects previously participating in two specific studies are eligible to enroll into this study. Enrollment is not open to subjects if not previously enrolled in studies B or B.
All subjects are excluded unless previously participating in studies B or B.
Patient must be willing and able to undergo the imaging studies outlined in the protocol.
Patient is willing and able to undergo standard of care imaging studies (same\n imaging/staging modality being used at each evaluation), which are anticipated to be\n performed prior to the initiation of therapy and subsequently every months.
Patients enrolled in any other clinical studies the investigator believes to be in conflict with this investigation.