NCT07228000 Bundled Cancer Screening and Genetic Services Navigation
| NCT ID | NCT07228000 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Georgetown University |
| Condition | Breast Cancer Screening |
| Study Type | INTERVENTIONAL |
| Enrollment | 820 participants |
| Start Date | 2026-05-06 |
| Primary Completion | 2029-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 820 participants in total. It began in 2026-05-06 with a primary completion date of 2029-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to test bundled familial cancer risk assessment + multicancer (colorectal + breast) vs. single (breast) cancer navigation, using a wait list control for colorectal cancer screening referral and navigation. Among those eligible, this study will test usual care referral to genetic services vs. pretest education + usual care referral. The study also will assess how bundled multicancer navigation works and for whom it is most effective through a multisite, mixed-methods patient- and organization-level process evaluation.
Eligibility Criteria
Inclusion Criteria: 1. Seeking screening navigation services through programs at a participating site (Georgetown Lombardi Cancer Center or Helen F. Graham Cancer Center \& Research Institutes) 2. Eligible for breast cancer screening while also due and eligible for colorectal cancer screening (per USPSTF guidelines) 3. Female sex 4. Aged 45-74 5. Identify as Black/African American race and/or Hispanic/Latin(e)(a) ethnicity 6. Speak English or Spanish with enough fluency to complete study activities 7. Stated willingness to comply with all study procedures (navigation, surveys) and availability for the duration of the study 8. Provision of completed electronic informed consent form Exclusion Criteria: 1. Not engaged with or planning to use navigation programs at Georgetown Lombardi Cancer Center and Helen F. Graham Cancer Center \& Research Institute 2. Not eligible for breast cancer screening or not due and eligible for colorectal cancer screening (per USPSTF guidelines) 3. History of breast and/or colorectal cancer; or Reporting symptoms related to breast and/or colorectal cancer (e.g., GI bleeding, breast mass) 4. Male sex, Intersex, or other sex 5. Under age 45 or over age 74 6. Identifies as neither Black/African American race nor Hispanic/Latin(e)(a) ethnicity 7. Speaks neither English nor Spanish with enough fluency to complete study activities 8. Stated unwillingness to comply with study procedures (navigation, surveys) or unavailability for the duration of the study 9. Inability to provide electronic informed consent, or needing another person to authorize informed consent on their behalf
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07228000 clinical trial?
This trial is open to female participants only, aged 45 Years or older, up to 74 Years, studying Breast Cancer Screening. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07228000 currently recruiting?
Yes, NCT07228000 is actively recruiting participants. Contact the research team at sco4@georgetown.edu for enrollment information.
Where is the NCT07228000 trial being conducted?
This trial is being conducted at Newark, United States, Washington D.C., United States.
Who is sponsoring the NCT07228000 clinical trial?
NCT07228000 is sponsored by Georgetown University. The trial plans to enroll 820 participants.
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