Researchers

Proposing a Research Study

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The Cancer Genetics Network is a registry of individuals who have a personal or family history of cancer, and who may be interested in participating in studies about inherited susceptibility to cancer. The CGN offers individuals a unique opportunity to keep up to date on cancer genetics and to potentially participate in studies.

The CGN is an important vehicle to conduct studies that will provide much-needed clinical information to help individuals who are potentially predisposed to cancer, or who are at high risk for cancer because of a family history of the disease or of known genetic predisposition. Previous CGN studies have included screening studies in breast and ovarian cancer, and behavioral studies on the effects of risk information.

Investigators seeking to develop research projects should be aware of the wide array of CGN resources that may be accessed to conduct their research. In particular, investigators should note that study design expertise and advice on research populations are available and should be pursued early on in the planning process.

The CGN and its collaborating investigators are also supported by the Data Coordinating Center at Massachusetts General Hospital. The network is also aided by Yale University Informatics. This collaborative group can ship and track biospecimens as needed, design specialized data systems to support the informatics needs of investigators, provide biostatistical support, if desired, and provide access to a database of 26,000 individuals with cancer and/or a family history of cancer.

Some of the available CGN resources are:

  • Statistical Support
  • Core Data from Registry of CGN Participants
  • Biorepository
  • Population and clinically based ascertainment of study populations
  • Infrastructure for clinical trials
  • Informatics support, including Trial DB
  • Communication infrastructure utilizing telecommunication and Internet resources
  • Cancer genetics education infrastructure
  • Genetic counseling and behavioral research
  • Cancer genetics laboratories
  • Cancer genetic counseling and testing services

Please contact us for or information regarding available participants, specimens, and/or proposing a CGN study.


Standard Operating Procedure for CGN Proposal Review and Study Initiation

Overview of Study Proposal and Initiation Process

Step Approximate Time to Completion
1: Submission and review of study concept 4 – 6 weeks
2: Submit proposed budget 1 – 2 weeks
3: Develop study forms/database
4: Develop Procedure Manual 2 – 4 weeks
5: Obtain IRB approval 2 – 4 weeks
TOTAL TIME TO STUDY START 9 – 16 weeks

The process for review and initiation of studies using CGN resources is described in detail below:

Step 1: Submission and review of study concept
Investigators are asked to complete the CGN Concept Proposal Form (see below), and submit completed forms via e-mail to Nora Horick at nhorick@partners.org. Initial review of submitted proposals will be conducted by a sub-committee of the CGN’s Steering Committee, comprised of members with expertise in the research area. Comments and questions will be returned to the investigator within 2 weeks of proposal submission. Once the investigator addresses the comments and questions of the sub-committee, the investigator will be invited to present the proposal during the next monthly Steering Committee teleconference. If necessary, the investigator will be asked to address any further questions or concerns raised by the Steering Committee. The Steering Committee will vote on the finalized proposal via e-mail. Following the Steering Committee vote, investigators will be notified in writing that the proposal (1) is approved, (2) is rejected, or (3) requires further development. Once approved, initiation of the study will proceed, as described in Steps 2 – 5 below. Please note that preference will be given to investigators who have already secured funding for their planned research.
Timeline for completion of Step 1: 4 – 6 weeks

Step 2: Submit proposed budget describing how CGN centers/DCC will be compensated by investigator
Investigators must provide funding to cover the costs of recruitment and enrollment of study participants, collection, storage, and shipment of biospecimens (if applicable), data collection and entry, and other costs associated with conducting the proposed research. The Data Coordinating Center (DCC) will work with the investigator to identify the research needs and determine the appropriate reimbursement to the participating institutions for conducting the study.
Timeline for completion of Step 2: 1 – 2 weeks

  • Funding Considerations
    While the CGN does not have funding for new studies, the existing infrastructure and available resources make conducting scientific studies highly streamlined and cost-effective. Each of the participating institutions has already established mechanisms for participant recruitment and enrollment, data collection and entry, and the collection, storage, and shipment of biospecimens. Database tools, including data entry using scannable forms and web-based entry using TrialDB are already being used by all CGN centers. There are no software/hardware requirements and training for the centers would be minimal. Thus, using the CGN to conduct a research study allows for significantly reduced study budgets.

Step 3: Develop study forms/build study database
The DCC will assist the investigator in developing the forms and questionnaires used to collect study data. Depending on the nature of the project, the DCC may create scannable/faxable forms for data collection. Once all study forms and questionnaires are finalized, the DCC will set-up a web-based database (TrialDB), for entry and storage of the study data. A description of TrialDB can be found at the website below. http://ycmi.med.yale.edu/TrialDB/
Timeline to completion of Step 3: 2 – 4 weeks (concurrent with Step 4)

Step 4: Develop Procedure Manual
The Procedure Manual will serve as the set of detailed operating guidelines for conducting the research at the study sites. Specific information regarding eligibility; completing of study forms and questionnaires; data entry and management; collection, handling, storage, and shipment of biospecimens; and other study procedures are documented in the Procedure Manual. The DCC will work with the investigator to develop this document.
Timeline to completion of Step 4: 2 – 4 weeks (concurrent with Step 3)

Step 5: Obtain IRB approval
IRB approval is needed by the participating institutions, as well as the DCC, in order to begin the study. The DCC will coordinate with participating institutions to provide all information necessary to submit the IRB application. The DCC will track and monitor IRB approval at the sites to ensure that initial and approvals are obtained in a timely manner.
Timeline to completion of Step 5: 2 – 4 weeks

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