An observational study in Colon Cancer and Breast Cancer, sponsored by National Human Genome Research Institute (NHGRI). Recruiting at 1 site in United States. Open to participants aged 1 Month to 105 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by National Human Genome Research Institute (NHGRI) · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 1,122 studies in Colonic Neoplasms with a site in United States — 116 open to participants now, 190 under way, 14 of them phase 3. Colonic Neoplasms · United States.
Among the 1,122 studies in Colonic Neoplasms with a site in United States, this one is the 12th largest by planned enrollment of the 181 observational ones that give a count, is one of 31 that started in 2014, is one of 181 observational ones, reaches primary completion later than 186 of the 187 other live ones, and was the 715th registered.
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
Browse Colonic Neoplasms studies →116 of the 1,122 studies in Colonic Neoplasms with a site in United States are open now. Recruiting first, the newest first:
Solstice Oncology, Inc. · Sites in United States, Belgium, Italy and 3 more countries
Ages 18+
LTZ Therapeutics, Inc. · Sites in United States
Ages 18+
Northwestern University · Sites in United States
Ages 18+
BigHat Biosciences, Inc. · Sites in United States
Ages 18+
Fox Chase Cancer Center · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 327 Colonic Neoplasms studies recruiting now, 204 (62%) set no upper age limit and 71 (22%) stop at 75 or younger; 19 take children under 18; 34 take healthy volunteers.
This study: 1 Month to 105 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,122 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 353 · Phase 2 341 · Phase 3 87 · Phase 4 10
First in 1981; this study’s year is marked. 31 started in 2014.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 5,000 is above the median of 227 across 555 observational studies indexed under Colonic Neoplasms.
Median enrollment 50 across the 864 interventional studies, 220 across the 181 observational. Of the 839 that completed or were terminated, 241 (29%) have results posted.
This tab as a report to print or save as PDF → With an account.
228 of 1,122 have an industry lead sponsor. The 10 most frequent:
National Human Genome Research Institute (NHGRI) is the lead sponsor of 203 studies on the registry; 33 are open to participants now.
National Human Genome Research Institute (NHGRI) has 4 studies filed under Colonic Neoplasms — fewer than ten, so there is no comparison to draw.
61 of the studies in Colonic Neoplasms with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03803553Phase 3Massachusetts General HospitalIdentification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer | 2026-12 |
| NCT06191185University of California, San FranciscoIMProving Adherence to Colonoscopy Through Teams and Technology | 2026-11-27 |
| NCT07023731Arvinas Inc.A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation | 2026-11-30 |
| NCT00579163Memorial Sloan Kettering Cancer CenterAscertainment of Peripheral Blood or Saliva Samples for Genetic Epidemiology Studies of Familial Cancers | 2026-12 |
| NCT07224464New Phase Ltd.The Sarah Nanotechnology System for Treatment of Advanced Metastatic Solid Tumors Using Hyperthermia. | 2026-12 |
Add all 61 to your calendar (.ics) → With an account.
Among the 1,122 studies in Colonic Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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....
The implementation of genome and exome sequencing creates challenges and opportunities, particularly with respect to the return of medically-actionable secondary findings (SF). This study seeks to investigate the utility and effectiveness of returning SF generated via research or clinical sequencing by studying individuals who have received such findings. Our objectives with this protocol have evolved over time and have been substantially informed by our experiences in returning SF through sequencing initiatives such as the ClinSeq(R) study, the Clinical Center Genomics Opportunity (CCGO), and the Secondary Genomic Findings Service (SGFS). Our work with these studies/initiatives suggests that much remains unknown about how recipients of SF understand these findings, communicate them to their health professionals and families, and whether they adhere to recommended health-preserving actions in both the short and long-term. As well, recipients of SF are an unselected population in which to investigate penetrance of disorders associated with SF genes. Thus, this protocol aims to explore important questions of clinical utility associated with SF return and penetrance of SF-related disorders. Healthcare actions and family communication (clinical utility) are assessed by interviews and surveys with SF recipients. This protocol also includes a pilot program in which selected participants will be invited to the NIH for bespoke phenotyping to uncover the presence of disease and explore avenues to develop interventions to enhance outcomes.
Individuals who have participated in a sequencing study at the NIH or elsewhere who have have received secondary findings through other means are eligible.
We employ a referral form through SurveyMonkey to receive referrals from recruitment partners or self-referrals. This serves as an intake form and self-reported eligibility review. This form asks for contact information, key information about the prospective participant s SF,
and subjective understanding of their result.
If we conclude, based on a review of the SF and available personal and/or family history, that the pathogenicity of the SF is not at least likely pathogenic, that participant may be eligible for the survey, interview, and/or re-contact for future follow-up, but will not complete any other protocol procedures (such as cascade testing). If a participant is consented and information arises during the social and behavioral study procedures that lead study staff to believe the genetic result does not qualify as an SF, the participant will be
considered a screen failure and will not continue with study procedures.
We plan to offer enrollment in this protocol to English- or Spanish-speaking recipients of SF. We do not have trained staff who can conduct the interviews in languages other than English and Spanish.
If a caregiver of a minor or adult who is unable to consent is enrolled as an index participant to complete the survey and interview on behalf of the SF recipient, they may also be eligible for cascade testing to relate presence of an SF-related phenotype in a family member with presence or absence of SF genotype.
-We may enroll a child in this protocol if he/she is the only person in his/her family who has the SF, is symptomatic of the disease, or is in the age range to receive screening for the disease (e.g., Wilson disease and familial hypercholesterolemia have childhood onset).
We will not enroll neonates (less than one month old).
member and provide a copy of the NIH Frequently Asked Questions (FAQs) for Staff Who are Considering Participation in NIH Research , before consent is obtained.
Family members of individuals who have received secondary genomic findings after exome/genome sequencing
Individuals who have received secondary genomic findings after exome/genome sequencing
Health impacts of SF receipt
We will assess the health impacts of SF receipt and healthcare processes affecting outcomes in SF recipients.
Time frame: enrollment and return of results
Adherence to medical recommendations
We will assess what individual, community, and systemic factors influence recipients' follow through on recommendations and how they communicate SF results with family members.
Time frame: enrollment and return of results
Family based positive predictive value
We will assess penetrance using the family-based positive predictive value metric
Time frame: return of results and cascade testing
Responses and perceptions
We will assess affective responses and healthcare and behavioral changes to receiving positive SF results
Time frame: enrollment and return of results
Plan to share: No
Started Sep 2014 (actual). Primary completion is estimated for Dec 2099, 1,023 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Human Genome Research Institute (NHGRI) →