[c09aa8]: / clusters / 9knumclustersv2 / clust_556.txt

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PRE-REGISTRATION ELIGIBILITY CRITERIA
PRE-REGISTRATION ELIGIBILITY CRITERIA:
PRE-REGISTRATION
PRE-REGISTRATION ELIGIBILITY CRITERIA (STEP )
PRE-REGISTRATION ELIGIBILITY CRITERIA (STEP )
PRE-REGISTRATION EXCLUSION CRITERIA
Registration must be completed =< days of pre-registration
EXCLUSION CRITERIA FOR PRE-REGISTRATION:
PRE-REGISTRATION (OPTIONAL)
PRE-SCREENING ELIGIBILITY
PRE-REGISTRATION
PRE-REGISTRATION EXCLUSION CRITERIA
PRE-REGISTRATION ELIGIBILITY
=< days post pre-registration
PRE-REGISTION ELIGIBILITY
ELIGIBILITY CRITERIA FOR PRE-REGISTRATION
EXCLUSION CRITERIA FOR PRE-REGISTRATION
PRE-REGISTRATION:
PRE-REGISTRATION
Requiring ongoing blood product support at time of pre-registration
PRE-REGISTRATION (PRE-SURGERY) ELIGIBILITY CRITERIA
Pre-registration eligibility criteria continue to be met
PRE-REGISTRATION ELIGIBILITY CRITERIA
PRE-REGISTRATION
PRE-REGISTRATION ELIGIBILITY CRITERIA
PRE-REGISTRATION EXCLUSION CRITERIA: Prior chemotherapy for this cancer (excluding initiation of best practice chemotherapy to be given as standard of care, which may be initiated after the pre-registration bone marrow collection but before final confirmation of eligibility and randomization)
PRE-REGISTRATION EXCLUSION CRITERIA: Previous treatment with trastuzumab or any other Her targeted therapy
REGISTRATION EXCLUSION CRITERIA: Prior chemotherapy for this cancer (excluding initiation of best practice chemotherapy to be given as standard of care, which may be initiated after the pre-registration bone marrow collection but before final confirmation of eligibility and randomization)
PRE-REGISTRATION
c-KIT mutation status determination, local versus central assessments; at least one must apply:\r\n* Performed locally by polymerase chain reaction (PCR) and sequencing prior to pre-registration: The melanoma harbors at least one mutation in exon , , , or of the c-KIT gene; NOTE: registration to step may occur upon confirmation of pre-registration Or\r\n* Performed locally by PCR and sequencing prior to pre-registration: if the melanoma harbors at least one mutation in the c-KIT gene but is not in an exon listed or is uncertain whether it is in one of these exons then eligibility to register to step requires approval of a designated central reviewer; submit the cKIT report within hours after pre-registration as indicated Or\r\n* If local assessment is not possible, metastatic (preferred) or primary tumor tissue should be on hand PRIOR to pre-registration and will be submitted to Massachusetts General Hospital Pathology (MGH) within working days following pre-registration as outlined; if submission of tissue will be submitted more than working days after pre-registration, immediately notify MGH (Massachusetts General Hospital) to discuss the potential submission timeline\r\n* IMPORTANT: if the c-KIT status will be determined by MGH, strict attention is to be paid to the timeframes dictated; specifically, clinical assessments which must fall within weeks of registration to treatment (step ) may be performed or repeated during pre-registration to fall within the required timeframe
PRE-REGISTRATION (STEP ) ELIGIBILITY CRITERIA:
PRE-REGISTRATION EXCLUSION CRITERIA
PRE-REGISTRATION ELIGIBILITY CRITERIA:
PATIENT PRE-REGISTRATION ELIGIBILITY CRITERIA:
PRE-REGISTRATION EXCLUSION
PRE-REGISTRATION EXCLUSION:
PRE-REGISTRATION EXCLUSION CRITERIA
PRE-REGISTRATION EXCLUSION CRITERIA
PRE-REGISTRATION EXCLUSION CRITERIA
PRE-REGISTRATION EXCLUSION CRITERIA
PRE-REGISTRATION ELIGIBILITY CRITERIA