CCSC Proposal Submission and Review

Proposals for use of specimens from phase 2/3 and phase 3 NCTN clinical trials are submitted through the NCTN Navigator clinical trials specimen resource.

Proposals for use of biospecimens from NCT Network Group phase 2 clinical trials should be submitted directly to the CTEP PIO.

All submission formats require that the proposal PI be a CTEP-registered investigator.

Submitting a CCSC Proposal

Step 1. Submit an LOI in NCTN Navigator

Prior to submitting a correlative study proposal for CCSC review, investigators must submit an LOI to confirm feasibility.

Read the NCTN Navigator FAQ for detailed instructions on submitting an LOI or proposal in Navigator.

Submit a Letter of Intent (LOI) for feasibility review.
If you receive a report that the LOI is not feasible, you will need to revise your approach and submit a new LOI.
If the report indicates feasibility, you may submit a full proposal for CCSC review using the proposal submission form in Navigator.

Download a copy of the CCSC Proposal Submission Form.

2. Complete the CCSC Proposal Submission Form.

Each section of the form includes prompts for critical information, such as the sample, assay, and statistical specifications that are required.

The proposal submission must include a pdf document with letters of support from co-investigators, including a letter from the study’s primary statistician.

Incomplete proposals may be returned and/or administratively disapproved.

What makes a successful CCSC Proposal?

A successful proposal submission must include all of the following information.

For each proposed biomarker/analyte, provide background data supporting the proposed hypothesis AND evidence that the proposed assay works in the targeted biospecimen type, with appropriate quality control and quality assurance.
If a gene signature will be studied, the genes included in the signature must be named.
A complete statistical section, written by (or with support from) a statistician. The statistical analyses proposed should align with the hypotheses proposed and cutpoints, if used, should be identified and supported with data.
A statistician must be listed in the co-investigators section, and their letter of support must be included with the submission.
Letters of Collaboration, including from the primary statistician, must be obtained and provided with the study proposal in a single pdf upload document.
A clear statement of why that particular clinical trial’s specimens are needed. It should be apparent that the investigators understand the trial.
Specimens from a positive randomized phase 3 trial should be used for validating a locked down assay(s) and cut-points. Specimens from such trials will rarely be considered for exploratory use. For a description of conditions under which proposals for exploratory uses of NCTN specimens might be acceptable, please see the Proposal Evaluation Guidelines.

CCSC Proposal Review Process

Step 1: Administrative review and assignment

After proposal submission, Navigator will forward the proposal for quality assurance review and subsequent assignment to one of two Core Correlative Science Committees: CCSC-A or CCSC-B. Each committee includes members with specialized expertise in specific oncology settings.

CCSC-A

Adult solid tumors
Overflow may be assigned to CCSC-B

CCSC-B

AYA and pediatric cancer trials
Sarcomas and hematological malignancies

Proposals are accepted through Navigator on a rolling basis. Proposals received and accepted by PIO ≥ 6 weeks before the standing CCSC review date will be scheduled for the call 6 weeks hence, pending review slot availability. If the Committee agenda is full, the proposal will be queued to the next available review slot.

Proposal review status can be viewed in Navigator. Inquiries should be addressed to the Navigator Front Door Service (FDS) at navigatorcontact@imsweb.com.

STEP 2: Scientific Review

Proposals will be reviewed by the NCTN-CCSC for scientific merit, feasibility, and appropriateness of the statistical plan. Notification of the decision on your proposal is anticipated to be forwarded from CTEP PIO to you, via Navigator, within 2 weeks of Committee proposal review.

Possible review outcomes include:

Review Outcome	Description
Approved	See the post-approval instructions.
Approved-on-hold	Correlative science proposals may request biospecimens from a clinical trial conducted under a binding clinical collaborative agreement between CTEP and a Collaborator. These requests will be subject to review and comment by the Collaborator (e.g., the company that provided the drug) prior to final CTEP approval. These proposals, if approved by the NCTN-CCSC, will therefore receive an approval-on-hold and will be forwarded to the Collaborator for comment, due within approximately 2 weeks. Final CTEP approval will be given after NCTN-CCSC and Collaborator comments have been addressed. Note: Proposals from other investigators may be under review or approved during the time of your proposal development and review. These other proposals may, if approved and funded, lead to biospecimen release that may reduce the biospecimen inventory available for release to your proposal. Biospecimens are not allocated to your proposal until it receives full approval.
Revisions requiring a response	The final decision requires clarification in assay parameters and/or statistical plans. Proposals for which revisions are required must be resubmitted for CCSC review within 3 months or will be administratively withdrawn.
Disapproved	Proposals that are disapproved may only be resubmitted at a later date as a new proposal, should new and compelling data and/or supportive information arise.
Not forwarded to committee	Proposals not forwarded to Committee are administratively disapproved by CTEP. Reasons for such disapproval may include: lack of sufficient information to analyze the science, feasibility, and/or statistical plan inappropriate use of samples (see the Proposal Evaluation Guidelines) If/when resubmitted, such proposals will be entertained as de novo submissions.