Specimen Set Request Form

To request specimen reference sets from the Early Detection Research Network, fill out the form below.

Select one or more reference sets
Name of the investigator.
Institution requesting the specimens.
The name of the person filling out this form.
Email address at which you can be reached.
Contact telephone number.
Select all that apply.
For example, "lung, ovary".
Expected duration of the study in months.
Select the kind of specimen; if you select Other, fill in the next blank.
If you selected "Other", enter the desired specimen type.
The minimum volume of each sample requested; include appropriate units such as μL (microliters), g (grams), etc.
Do you have approval from your Institutional Review Board to work with the requested samples?
If you answered "yes", enter your IRB number. If you answered "pending", enter the expected approval date.

Funding

Check one of the three boxes below:

↑ If you check the box above, please provide the following:

↑ If you check the box above, please provide a letter of committment to:

EDRN DMCC at COMPASS
Fred Hutchinson Cancer Center
1100 Faireview Ave N #M3-A306
Seattle WA 98109-1024
United States

↑ If you check the box above, please provide the following:

Scientific Proposal

For the Scientific Proposal, please upload a document (PDF preferred, but Microsoft® Word is acceptable) consisting of 3–5 pages of text and figures that addresses the following items:

  1. Clinical Relationship: Clearly state the clinical question that you are trying to address: risk assessment, early detection, diagnosis or prognosis. How would the reference samples expedite addressing the intended clinical question?
  2. Background and Significance: Clearly state the scientific rationale of the proposal for using the requested specimen reference set(s). Describe your biomarker/platform and how you came upon its discovery/development for potential application in cancer detection.
  3. Preliminary Data & Methods: Provide sufficient information describing how experiments were performed, details on convenience samples used, and presentation of data in terms of specificity, sensitivity, and variance of your measurements. Explicit description of your studies will facilitate review considerations. Figures and other supporting documentation can be appended after your proposal.
  4. Data Analysis Plan: Specify whether you will need a training set in addition to a blinded test set. Provide adequate detail concerning how statistical analysis of your data coming from these samples will be performed and a justification that the requested references set(s) is/are large enough to demonstrate the utility of the biomarker. Describe the statistical resources at your disposal. If you require statistical support, EDRN can assist you with this.
  5. Future Plans: If the biomarker is found to have promising performance characteristics, the EDRN might be interested in working with you to proceed to Phase Ⅱ clinical validations. Address each specific scenario below according to your intentions:
    • Do you plan to approach EDRN for funding and collaboration in proceeding to a Phase Ⅱ validation study? If not, do you have other resources where validation can be accomplished? Describe clearly other resources at your disposal and how they are sufficient to complete a larger Phase Ⅱ validation study if you will not seek help from the EDRN.
    • Are you amenable to working within the collaborative framework of EDRN in proceeding to Phase Ⅱ studies?
    • If deemed beneficial, will you be amenable to including your biomarker into a larger panel of biomarkers for Phase Ⅱ validation?
    • If refinements will improve the performance of the biomarker test, will you concur with further development of the test? Will it be advantageous to include resources of EDRN for this purpose?
PDF file preferred, but Word is also acceptable; 3–5 pages please.

Affirmations

By checking this box, I agree not to resell or release the reference set or sub-aliquots from this set to an investigator not directly connected with this application.
By checking this box, I agree to complete the assays on the reference set specimens and return results to the EDRN DMCC within 6 months of their receipt with an opportunity for an extension.
By checking this box, I agree to release assay results for posting on LabCAS, a secure domain on the EDRN website, 3 months after I have received the unblinded results back from the DMCC for my review.
Type your name in lieu of providing a signature.

After submitting this form, investigators shall be notified within three months regarding approval for use of a specimen reference set.

Investigators applying for use of an EDRN reference set will be notified within 3 months about approval for use of a set. Investigators who successfully apply must also complete a separate MTA with the National Cancer Institute. Neither NCI nor the EDRN DMCC will claim any rights to your data including the statistical analysis conducted by the EDRN DMCC.