Exceptional Responders

Exceptional Responders Initiative

The National Cancer Institute (NCI) has embarked on the Exceptional Responders (ER) Initiative to understand the molecular underpinnings of exceptional responses to treatment, primarily via chemotherapy, in cancer patients. Exceptional responders are patients who have a unique response to treatments that are not effective for most other patients. For this initiative, exceptional responders will be identified as patients enrolled in early-phase clinical trials in which fewer than 10 percent of the patients responded to the treatments being studied; patients who were treated with drugs not found to be generally effective for their disease; patients who were treated in later-phase clinical trials of single agents or combinations; and even patients who were treated with established therapies. The goal is to determine whether certain molecular features of the malignant tissue can predict responses to the same or similar drugs.

The BCR is responsible for the collection and processing of specimens for the Exceptional Responders Initiative. After specimens qualify by pathology and molecular metrics at the BCR, molecular analytes are then distributed to the Baylor College of Medicine and Foundation Medicine, Inc. characterization centers. The BCR receives and validates clinical data using the BCR’s validation engine, prior to uploading to the Data Coordinating Center (DCC)/Data Genomic Data Commons (GDC).

Questions from investigators, physicians, and hospitals looking to contribute tumor samples may be sent by email to the Exceptional Responder’s email box at: NCIExceptionalResponders@mail.nih.gov

Click here to visit the National Cancer Institute's Questions and Answers page for Exceptional Responders.

Click here to visit the clinicaltrials.gov website for more details on the ER #NCT02243592 trial.

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