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Are individuals with comorbidities excluded from the Vanguard Study?
No. The Vanguard Study will recruit participants without cancer or symptoms of cancer. Individuals with comorbidities that are managed will not be excluded unless their comorbidities interfere with their ability to adhere to the study protocol.
Can participants enrolled in another MCD trial also enroll in the Vanguard Study?
It is unlikely that participants in other MCD trials would be eligible for the Vanguard Study. The specific eligibility criteria will be described in the protocol approved by the CSRN Steering Committee.
What are the characteristics of the population intended for recruitment to the Vanguard Study?
Overall, CSRN studies will seek to accrue participants who reflect the population that would benefit from cancer screening and include individuals who are traditionally underrepresented in clinical trials. Each ACCESS Hub will contribute to this goal by reflecting the diversity of their communities and catchment areas in their participant accrual demographics. For the Vanguard specifically, the population is intended to be asymptomatic, average risk individuals.
For the Vanguard Study, what are the age eligibility requirements?
The age eligibility requirements are not yet specified. The expectations are that the Vanguard Study would include asymptomatic adults that represent a population that would have a reasonable cancer incidence. The preliminary design includes individuals aged 45 to 70. The age eligibility requirements will be determined by CSRN investigators and described in the protocol approved by the CSRN Steering Committee.
Should applicants exclude symptomatic participants and those with high-risk features such as a family history of cancer?
The Vanguard Study is expected to recruit asymptomatic, average-risk individuals. The eligibility details will be developed by the CSRN Steering Committee for the Vanguard Study. It is anticipated that the specific high-risk individuals will not be explicitly excluded. However, `standard of care’ screening for high-risk individuals may be substantially different than screening for average-risk individuals. Future CSRN studies may evaluate different screening technologies for populations of different risk categories.
Can Vanguard participants also be participants in NIH All of Us or NCI Connect studies?
Have the protocol or data collection tools been written for the Vanguard Study?
No. The NCI has provided a preliminary design for the Vanguard Study, but the protocol and data collection tools will be designed by appropriate CSRN work groups.
Will there be additional questionnaires collecting social determinants of health measures from Vanguard Study participants or NCCN distress thermometer, etc.?
Possibly. The final protocol for the Vanguard will be determined by the CSRN Steering Committee and may include collecting data to address questions related to social determinants of health.
How long will participants in the Vanguard Study be followed and will they be asked to consider participating in future screening trials?
It depends on the findings of the Vanguard Study whether or not the whole Vanguard pilot cohort is moved into a larger randomized control trial after the initial four-year funding period. Applicants should describe plans to follow Vanguard Study participants during the four-year project period.
Will the NCI provide electronic consent for the Vanguard Study?
This is to be determined by the CSRN Steering Committee. The process of using electronic consenting will be one of the aspects under consideration. The Coordinating Center and the Statistics and Data Management Center will develop the logistics and operational considerations for conducting the study. In their proposal, applicants are free to envision the most efficient design or ways of conducting the study that they think is possible.
Will the diagnostic pathways for signal positive workups in the Vanguard Study be pre-established by NCI?
The CSRN Steering Committee will describe the diagnostic pathways in the approved Vanguard Study protocol. NCI has multiple working groups involved in the conceptualization and design of the CSRN Network, Vanguard Study, and subsequent large randomized controlled trial. NCI expects that when the Network is established and fully funded, NCI will partner with the CSRN investigators to describe and develop the final diagnostic pathways and clinical workflows for the Vanguard Study protocol.
Standard of Care Screenings
For the Vanguard Study, who determines the type(s) of cancer screening offered and the methods of cancer screening?
Standard of care cancer screening will follow US standards for all appropriate cancer types. Specific standards will be clarified in the protocol. Each ACCESS Hub may have a different method for offering standard of care screening and should describe it in their application.
Will the ACCESS Hubs be required to perform standard of care screenings as part of the Vanguard Study?
Standard of care (SOC) screenings must be available to all Vanguard Study participants. In their proposal, applicants should consider and describe what would be feasible and operationally sound to meet that requirement for their specific organizations. After the CSRN has been established, the method of SOC screenings will be described in the study protocol developed by the CSRN Steering Committee.
Multi-Cancer Detection (MCD) Assays
If we are currently involved in a clinical study with an MCD company, would we be expected to terminate that relationship before joining the Vanguard Study?
Not necessarily. You would be required to disclose your involvement in a clinical study with an MCD company and describe proposals for how the potential or perceived conflict of interest would be managed if that assay is included in the Vanguard Study.
For the Vanguard Study, how will the specific MCD(s) be selected for the intervention arm participants?
The NCI is developing the criteria for MCD selection and has issued an RFI [NOT-CA-22-033] to determine interest in MCD company participation. Through a transparent selection process, NCI will determine the MCDs available for the Vanguard Study and will establish formal agreements with those companies for assay inclusion in CSRN studies and trials. The CSRN investigators will have an opportunity to provide input.
Will there only be two MCD tests in the Vanguard Study?
Yes. For application and budgeting purposes, assume two MCD tests in the Vanguard Study.
Will participants in the Vanguard Study be given results of their MCD tests? Will ACCESS Hubs be required to provide follow-up?
Yes. Participants in intervention arms of the Vanguard Study will receive their MCD test results. ACCESS Hubs must offer participants the appropriate follow-up diagnostic workup, as described in the study protocol.
Participants will be followed for cancer and mortality endpoints through the initial four-year CSRN funding cycle.
Will the Vanguard Study require an NIH Central IRB (CIRB)?
Yes. The Vanguard Study will use the NCI Central IRB. Applicants should describe their experience with any single or central IRB.
Will all ACCESS Hubs funded for the Vanguard Study move forward to the anticipated randomized control trial, or will they have to re-apply/compete for that next phase?
The initial funding cycle is four years. Any potential future funding for the CSRN will be based on competitive applications and peer review, so initial CSRN awardees would need to recompete to be considered. The CSRN is initially funded for only four years so that, in part, NCI can evaluate how the Network may need to be modified for future funding cycles, including potentially expanding the number of ACCESS Hubs.
Last updated: 01/06/2023