Go to the NCI-MATCH / EAY131 Trial Education Materials page for more information about the protocol, eligibility, biopsies, imaging and correlative science.
National Cancer Institute-Molecular Analysis for Therapy Choice, known as NCI-MATCH or study EAY131, is a phase II precision medicine trial that seeks to determine whether matching certain drugs or drug combinations in adults whose tumors have specific gene abnormalities will effectively treat their cancer, regardless of their cancer type.
NCI-MATCH (EAY131) was co-developed by the ECOG-ACRIN Cancer Research Group and the National Cancer Institute. It is being led by ECOG-ACRIN through its Biomarker Sciences Program.
Listed below is general information to assist research personnel who are interested in participating in the study.
To participate in this trial, medical facilities (sites) must meet ALL of the criteria listed below.
EAY131 is the master protocol identification (ID) for the overall trial. Each treatment/genetic abnormality being studied in this trial is a substudy (or subprotocol) of EAY131, identified with an additional letter added to the end of the master protocol ID; EAY131-A, for example. All subprotocols must be used in conjunction with the master protocol, EAY131.
The master protocol and all subprotocol documents, along with related material, are password protected. Research personnel may access the documents on the NCI Cancer Trial Support Unit (CTSU) website.
ECOG-ACRIN members, please use the Member Login button at the top of this page to access the documents. For assistance with login credentials, call the ECOG-ACRIN Operations Office in Boston at 857-504-2900 during normal business hours.
NCI-MATCH (EAY131) opened to patient enrollment on August 12, 2015 with the master protocol and ten subprotocols. An additional 14 subprotocols were added on a rolling basis by late May 2016 through amendments to the master protocol. View the NCI-MATCH Active Trials Table.
In this trial, investigators register patients via the NCI Oncology Patient Enrollment Network (OPEN) Registration System, which is accessible 24 hours a day, seven days a week at the CTSU website.
The ECOG-ACRIN Central Biorepository and Pathology Facility is coordinating all aspects of the DNA sequencing of biopsy specimens, in what is referred to as Step 0 in the master protocol.
Next-generation sequencing detects genetic abnormalities that may be driving tumor growth and might be targeted by one of a wide range of drugs being studied in this trial. Therefore, the collection and submission of fresh tumor biopsy material for screening assessments are MANDATORY in this trial.
Blood specimens and additional end-of-treatment fresh biopsy material are requested from patients who have consented to allow the submission of these specimens for research. All specimen submissions MUST be logged and tracked in the ECOG-ACRIN Sample Tracking System. Guidelines are provided in Section 9 of the master protocol document, EAY131.
NCI-MATCH (EAY131) is being conducted exclusively in Medidata Rave®, the cloud-based clinical data management system used to capture, manage, and report clinical research data. Rave enables the user to record patient information (ie, visit, lab, and adverse event data) using forms that are customized for the study. Access to Rave requires only an internet connection and web browser.
There are no paper case report forms for this trial. Data is entered directly into Rave at the site by clinical research associates (CRAs). Central office data management is performed in Rave by the ECOG-ACRIN Data Management Team.
This clinical trial requires research personnel at participating institutions to complete training prior to starting data entry. Training courses are assigned through Medidata Rave® as eLearnings. Listed below are the required eLearnings that pertain to NCI-MATCH (EAY131):
Required for CRAs performing data entry in Rave:
Required for Principal Investigators and Study Chairs performing sign off on case report forms in Rave:
Optional eLearnings for all:
Inquiries about the NCI-MATCH (EAY131) study may be directed to:
ECOG-ACRIN Cancer Research Group
Operations Office – Boston
|Trial Educational Materials|
|NCI-MATCH / EAY131 for Researchers|
|ECOG Performance Status|