Pre-Application Webinars for Participant Engagement and Cancer Genome Sequencing (PE-CGS)


Overview

NCI's Division of Cancer Control and Population Sciences (DCCPS) will hold two pre-application webinars for the Participant Engagement and Cancer Genome Sequencing (PE-CGS) Network Funding Opportunity Announcements (FOAs) RFA-CA-19-045 and RFA-CA-19-046. These FOAs are associated with the Beau Biden Cancer Moonshot℠ Initiative that is intended to accelerate cancer research. Specifically, these FOAs fall under a scientific priority designated by the Blue Ribbon Panel (BRP) as Recommendation A "Establish a Network for Direct Patient Engagement."

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Webinars

The first webinar focused on introducing both funding opportunities and the second webinar focused on frequently asked questions for both funding opportunities.

NCI staff involved in these FOAs provided orientation to the above-referenced FOAs and technical assistance to potential applicants by explaining the goals and objectives and answering questions from webinar attendees.

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Frequently Asked Questions (FAQs) for RFA-CA-19-045 and RFA-CA-19-046

Please note that a correction notice has been published for RFA-CA-19-045.


1. Should each of the required genomic characterizations--whole exome sequencing, RNA sequencing, and low-pass whole genome sequencing--be performed in a CLIA-certified laboratory?

The whole exome sequencing should be performed in a CLIA-certified laboratory, allowing for the return of individual-level genetic information to those participants who are interested in receiving such data. However, the low-pass whole genome sequencing and the RNA sequencing need not be done using a CLIA pipeline.


2. Is it possible to perform the whole-exome sequencing in a research laboratory and follow up with clinical validation in a CLIA laboratory?

Hybrid approaches like sequencing in a research lab and validating actionable targets in CLIA will not be appropriate. We are expecting the return policy to evolve. Therefore, whole exome sequencing must be performed in a CLIA environment to allow for broader return of results in anticipation of these potential changes.


3. Is there flexibility is the selection of platforms for the genomic characterization?

For each cancer or population subset, the characterizations must include, at a minimum: whole exome sequencing; low-pass whole genome sequencing (coverage of 15X); and RNA sequencing. Therefore, alternative platforms for these required characterizations are not allowed. However, applicants may propose additional types of genomic characterizations, if appropriate, for the study focus. Note, all activities must be within the allowable budget (no more than $2.5 million direct costs per year).


4. What cancer type is appropriate for the Research Centers FOA (RFA-CA-19-045)? Is a specific cancer type appropriate for the FOA?

The U2C research centers should be centered on addressing a unique research knowledge gap in the genomic characterizations of tumors. Knowledge gaps proposed for characterization are expected to be mainly identified in Interest Areas 1-5 (see below). However, knowledge gaps outside of the first five interest areas may also be proposed with strong scientific justification.

  • Interest Area 1: Rare cancers or rare cancer subsets;
  • Interest Area 2: Highly lethal cancers;
  • Interest Area 3: Cancers with an early age of onset;
  • Interest Area 4: Cancers with high disparities in incidence and/or mortality;
  • Interest Area 5: Cancers in understudied populations; and
  • Interest Area 6: Other cancer and/or population subsets justified to be highly relevant to the goals of this FOA.

5. Does “Interest Area 3: Cancers with an early age of onset,” mean pediatric cancers or cancers that traditionally occur in older individuals impacting people of younger ages?

This FOA is intended to address knowledge gaps in both adult and pediatric cancers. For Interest Area 3, our intention was cancers that typically affect older individuals occurring in participants of younger ages. As far as many pediatric cancers are rare or understudied, these could also fit under the other areas of interest.


6. How many participants/tumors are required?

The proposed minimal number of unique tumors to characterize (i.e., the proposed number of participants to engage) should be sufficiently high to ensure rigorous and interpretable results for the specific research proposed. This number may differ depending on the cancer type selected.


7. We have already identified the population we want to engage for participation, but how important is it that we address research gaps in the genomic characterizations of tumors?

For applications to be considered fully responsive to the RFAs, it is critically important that the team identifies and articulates the particular knowledge gap(s) in the molecular characterization of a particular cancer and/or population subset: a subset/sub-type of a specific cancer (e.g., triple negative breast cancer) or cancer in a specific population (e.g., breast cancer in Hispanic women). To identify the genomic research gap you intend to fill, we encourage you to review and carefully consider the Interest Areas outlined in the RFAs and offer a compelling justification for your chosen focus.


8. Can we use an existing infrastructure or resource for enrolling cancer patients or study participants?

For the U2C, investigators are encouraged to build on existing infrastructures. However, it must also be possible for any participant meeting the inclusion criteria to have the ability to enroll in the project.


9. For RFA-CA-19-045, what if we do not complete our application in time for the October 30, 2019 submission date?

There are currently two receipt dates for the FOAs to allow for resubmissions or submissions of new applications that missed the initial submission deadline. However, the second receipt date will depend on the availability of funds.


10. Is it possible to apply for both the U2C (RFA-CA-19-045) and U24 (RFA-CA-19-046) FOAs?

Yes, the same institution/investigators can apply for both FOAs.


11. Are multi-PI mechanisms allowed for both FOAs?

Yes, multi-PI applications are allowable for both FOAs.


12. What is required for a Letter of Intent (LOI)?

As described in the FOA, the letter of intent should include the following information: Descriptive title of proposed activity; Name(s), address(es), and telephone number(s) of the PD(s)/PI(s); Names of other key personnel; Participating institution(s); and Number and title of this funding opportunity. This should be emailed to NCI_PE-CGS@mail.nih.gov.


13. What is meant by “participant engagement”?

For this FOA, we define participant engagement as an ongoing, mutually beneficial interaction between participants and researchers, where participants are included as an integral part throughout the research process, including the identification of research priorities and the design, conduct, and uptake of research. In direct participant engagement, research teams interact directly with participants or caregivers (via the web, social media, collaborations with patient groups or organizations, or using other forms of outreach), not necessarily through providers or the clinical setting.


14. What is the distinction between the Participant Engagement Unit (Unit 1) and the Engagement Optimization Unit (Unit 3)?

The Participant Engagement Unit (Unit 1) will be responsible for the implementation and operations of the participant engagement, while the Engagement Optimization Unit (Unit 3) provides supporting (behavioral/communication) research to develop and test the optimal approaches to participant engagement. The Participant Engagement Unit should develop initial protocols based on the state of the science for participant engagement, but with flexibility in the protocol to adapt to research findings from the Engagement Optimization Unit. In other words, the Engagement Optimization Unit is supporting fundamental (behavioral/communication) research that is directly relevant to the work performed by the Participant Engagement Unit. Moreover, the research performed in the Engagement Optimization Unit will iteratively guide the implementation and operations of the Participant Engagement Unit. It is likely that there may be some overlap in staff named for Unit 1 and Unit 3. Applicants should note in the RFA the specified required expertise for both units.


15. How much preliminary data is required for the Engagement Optimization Unit (Unit 3)?

You will want to provide some details on anticipated initial major research questions and include any specific (pilot) project ideas (e.g., testing different modes of obtaining consent or gauging participant preference in return of results). There should be enough detail for reviewers to feel confident that the research will be feasible and successful and will inform the larger protocol in Unit 1. However, by design, the Engagement Optimization Unit’s work will be iterative in nature, therefore providing comprehensive details of all the work that could be completed will not be expected.


16. Is there an extension of the submission deadline for investigators participating on a study section?

Since RFA-CA-19-045 and RFA-CA-19-046 does not use the standard receipt dates, the continuous submission policy does not apply. In addition, these FOAs will not accept any late applications. Therefore, there is no extension of the submission deadline for members of a study section.


17. Is it possible to include scientific aims for the Genomic Characterization Unit? Or should this unit be focused only on operations?

The aims for the Genomic Characterization Unit can include scientific research questions as long as they also address the required operations of the unit, i.e., to accomplish the genomic characterization of the cancer type or population subset selected to study. The Research Plan section for the Genomic Characterization Unit in the FOA emphasizes operational details; it is critical that applicants demonstrate the ability to accomplish the high-quality genomic characterizations and interpretations required for this initiative because this data will be shared as a resource to support future research—however, scientific research aims could be included. Please note that the details required by the FOA are meant to be a minimum; any additional details necessary for evaluation of the scientific approach should also be included.


18. What should I do if my consent form is more than 5 pages? What should I do if my study includes multiple consent forms? Is there any way to go beyond the 5-page limit for Attachment 3 the Example draft consent form(s)?

Unfortunately, for the 3rd attachment “Consent,” you must submit the draft consent form(s) document within the 5-page limit. The intention is for applicants to demonstrate their understanding of the requirements for consent for the populations they are engaging. We suggest that you provide the most critical content and then summarize the other important content or key aspects that are not provided to show reviewers that you have considered the critical components of the consent. We plan to advise the review panel about the challenges of providing draft consent documents in the 5-page limit.


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Scientific Contacts for Funding Opportunities

Please direct all inquiries about these webinars and the related FOAs to NCI_PE-CGS@mail.nih.gov.

Leah E. Mechanic, Ph.D., M.P.H.
Program Director
Genomic Epidemiology Branch
Epidemiology and Genomics Research Program, DCCPS

Elizabeth M. Gillanders, Ph.D.
Branch Chief
Genomic Epidemiology Branch
Epidemiology and Genomics Research Program, DCCPS

Wen-Ying Sylvia Chou, Ph.D., M.P.H.
Program Director
Health Communication and Informatics Research Branch
Behavioral Research Program, DCCPS

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