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Last Updated: 04/03/18

NCTN Core Correlative Sciences Committee (NCTN-CCSC)

Review process for investigators seeking to use biospecimens from National Clinical Trials Network (NCTN) Phase 3 cancer clinical trials.

Overview, Mission Statement, and Responsibilities

The biospecimen collections developed from cancer clinical trials conducted by the National Cancer Institute’s (NCI’s) National Clinical Trials Network (NCTN) are highly annotated with carefully collected clinical data, including outcome data.

The NCTN Core Correlative Sciences Committee (NCTN-CCSC) is charged with scientific review and prioritization of proposals requesting use of banked, non-reserved biospecimens collected from NCTN clinical trials for use in correlative science studies. The NCTN-CCSC has oversight for ensuring optimal use of these irreplaceable clinical trial biospecimens. The NCTN-CCSC is comprised of representatives from the NCTN and NCI who have expertise in oncology, laboratory science, translational medicine, pathology, statistics, biobanking, and patient advocacy.

The NCTN-CCSC prioritizes use of these valuable specimens for validation of fully specified (locked) prediction models and/or validation of pre-specified biomarkers for which substantial supporting evidence is provided. The context of the clinical trial from which specimens are requested should be essential to the questions posed by the proposed study. Data from large, randomized clinical trials should primarily be used to answer definitive correlative science hypotheses, and predictive biomarkers are preferred over prognostic biomarkers.

Although the NCTN-CCSC gives highest priority to validation efforts, exceptions may be made, as explained in the NCTN-CCSC Expanded Evaluation Guidelines section of this website. It is under this rubric that early biomarker discovery efforts may be considered.

The NCTN-CCSC does not perform the following:

  1. The NCTN-CCSC does not review or address use of clinical trial samples assigned for integral and integrated biomarkers that have undergone prior NCI review.
  2. The NCTN-CCSC does not review requests for use of clinical trial samples for trials that are still under DSMB oversight and/or have not yet reported out their primary endpoints.
  3. The NCTN-CCSC does not review requests for specimens from select trials that have their own special Steering Committee for reviewing specimen requests, particularly international trials led by non-US groups.
  4. The NCTN-CCSC does not review proposed uses of samples coming from:
    • Group biobanking protocols involving specimen collection not associated with a clinical trial or not collecting patient outcome data. Such requests are reviewed by other NCI committees.
    • Sample requests related to internal NCI collaborative processes, such as the Clinical Trial Sequencing Project or NCI Blue Ribbon Panel. Such requests are reviewed by other NCI committees.
  5. The NCTN-CCSC does not provide provisional letters of support in response to grant letter requests.
  6. Currently, the NCTN-CCSC does not review requests for specimens from pediatric trials; however, expansion to include these trials is pending. Requests for pediatric non NCTN clinical trial specimens should be directed to the Children’s Oncology Group.

Studies approved by the NCTN-CCSC

View the approved study list

Contact for NCTN-CCSC

For questions about the NCTN-CCSC, please email NCINCTN-CCSC@mail.nih.gov.