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Colon Cancer / Breast Cancer · Observational Study
ClinicalTrials.gov · August 13, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a prospective observational study registered to enroll 5000 participants with secondary findings from genome sequencing. The study aims to assess health impacts, adherence to medical recommendations, and participant understanding of genetic results through surveys, interviews, and optional clinical evaluation at the NIH Clinical Center. No results are reported in this registry record.
Observational. Colon Cancer, Breast Cancer; age from 1 Month; to 105 Years. Intervention: Cascade Testing; Secondary findings recipients. n = 5,000. 1 site: United States.
This is a prospective observational study registered to enroll 5000 participants with secondary findings from genome sequencing. The study aims to assess health impacts, adherence to medical recommendations, and participant understanding of genetic results through surveys, interviews, and optional clinical evaluation at the NIH Clinical Center. No results are reported in this registry record.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
This is a registry record for an ongoing observational study with no results reported; it describes planned enrollment, outcomes, and methods only.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT02595957). This is a study registration, not published results. Lead sponsor: National Human Genome Research Institute (NHGRI). Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 5000 participants (ESTIMATED). Conditions: Colon Cancer, Breast Cancer. Primary outcome measures: Health impacts of SF receipt , enrollment and return of results; Adherence to medical recommendations , enrollment and return of results; Family based positive predictive value , return of results and cascade testing; Responses and perceptions , enrollment and return of results. Brief summary: Background: Genes are the instructions a person s body uses to function. Genome sequencing reads through all of a person s genes. Everyone has many gene variants, and most do not cause disease. Some gene variants called secondary findings may be important for a person s health even if they are not related to the reason why a person had genome sequencing done. Researchers want to learn more about what it means to have a secondary finding. Objectives: To learn about how gene variants may affect a person s health. To learn about how people understand their genetic test results. Eligibility: People with secondary findings from genetic testing done as part of a research study, clinical care, or other methods. Design: Participants may be asked to do an online survey and phone interview to ask what they think about their results, their healthcare, and if they talk with their family about the result. Eligible participants may be offered a visit to the NIH Clinical Center where they will be evaluated for health problems related to the secondary finding. DNA samples that were already collected may be studied. Participants may be asked to send in a second DNA sample (blood or saliva). These will be used to verify any findings. Participants who have a secondary finding can get genetic counseling....
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.