Clinical trial Recruiting at 2 sites Observational Ages 1 Year to 99

Understanding rare tumors and genetic cancer risks in individuals and families

Official title: Rare Tumors and Cancer Predisposition in Individuals and Families

Run by National Institutes of Health Clinical Center (CC) · NCT05350761 · Data updated 2026-11-12

This study is trying to learn more about rare tumors and genetic cancer risks by looking at personal and family health histories of people with these conditions to help find better treatments in the future.

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Quick facts

Study typeObservational
Ages1 Year to 99 Years
SexAll
Enrollment500 (estimated)
SponsorNational Institutes of Health Clinical Center (CC)
NIH
Drugs / interventionsradiation
Locations2 sites (Bethesda, Maryland and 1 other locations)
StatusRecruiting
StartedMarch 10, 2023
Main results expectedDecember 31, 2035
Study endsDecember 31, 2035
Registry record updatedNovember 3, 2026
Trial IDNCT05350761 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals of any age with unusual tumors, a family history of cancer, or exposure to risk factors for cancer.

Probably not a fit

Patients without a personal or family history of rare tumors or genetic predispositions to cancer may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the natural history of individuals with rare tumors and genetic predispositions to cancer. Participants will provide detailed personal and family medical histories, and may undergo physical exams and provide biological samples. The study seeks to define the clinical spectrum of cancer predisposition syndromes, assess risks for family members, and identify relevant genetic factors. It will also facilitate the identification of candidates for future clinical trials at the NIH Clinical Center.

Why it matters

Potential benefit: If successful, this study could enhance understanding of cancer risks and lead to better prevention and treatment strategies for individuals with rare tumors.

How similar studies have gone: Other studies focusing on genetic predispositions to cancer have shown promise, indicating that this approach may yield valuable insights.

Who can join: the full rules

Show full inclusion / exclusion criteria
* INCLUSION CRITERIA:

Although specific familial syndromes vary in prevalence by sex, race or ethnicity, no one is excluded from participation by sex, gender, race or ethnicity. Since families participate in studies, the sex distribution is essentially balanced, and all ages are included. Minor children below the age of assent are actively studied only when the benefits of participation outweigh the risks.

Affected: An individual who meets any of the following criteria will be eligible to participate in this study:

1. Personal medical history of neoplasia of an unusual type, pattern, or number; or,
2. Known or suspected factor(s) predisposing to neoplasia, either genetic and/or congenital factors (birth defects, metabolic phenotype, chromosomal anomalies or Mendelian traits associated with tumors), environmental exposure (medications, occupation, radiation,

   diet, infectious agents, etc.), or unusual demographic features (very young age of onset, multiple tumors, etc.).
3. There is no age restriction; therefore including viable neonates However, children \< 3 years old will not come to the Clinical Center unless clinically indicated until they are \>= 3 years old.
4. Participant or their Legally Authorized Representative (LAR) must sign and date an IRB approved informed consent form (signed on paper or electronically for the Field Cohort / signed on paper for the Clinic Center Cohort)

Unaffected Controls: An individual who meets any of the following criteria will be eligible to participate in this study:

1. Family medical history of neoplasia of an unusual type, pattern, or number; or,
2. Known or suspected factor(s) predisposing to neoplasia, either genetic and/or congenital factors (birth defects, metabolic phenotype, chromosomal anomalies or Mendelian traits associated with tumors), environmental exposure (medications, occupation, radiation,

   diet, infectious agents, etc.), or unusual demographic features (very young age of onset, multiple tumors, etc.).
3. There is no age restriction; therefore including viable neonates. However, children \< 3 years old will not come to the Clinical Center unless clinically indicated until they are \>= 3 years old.
4. Participant or their LAR must sign and date an IRB-approved informed consent form (signed on paper or electronically for the Field Cohort / signed on paper for the Clinic Center Cohort)

Personal and family medical history will be verified through questionnaires, interviews, and review of pathology slides and medical records. For familial neoplasms, two or more living affected cases among family members are required. The types of suspected factors predisposing to neoplasia and/or familial tumors under active accrual and study will be investigator- and hypothesis-driven. This approach permits CGB investigators to remain alert to the opportunities afforded by clusters of rare tumors in families and individuals, and to be more responsive to the dynamic research priorities in cancer genetics.

EXCLUSION CRITERIA:

Affected: An individual who meets any of the following criteria will be excluded from participation in this study:

1. Referred individuals for whom reported diagnoses cannot be verified
2. Inability of the participant or LAR to understand and be willing to sign a written informed consent document.
3. Referred individuals who are eligible for other CGB protocols that are specific to a hereditary cancer syndrome (e.g., Li-Fraumeni Syndrome, Familial Melanoma) Unaffected Controls: An individual who meets any of the following criteria will be excluded

from participation in this study:

1. Referred families for whom reported diagnoses cannot be verified
2. Inability of the participant or LAR to understand and be willing to sign a written informed consent document.
3. Referred families who are eligible for other CGB protocols that are specific to a hereditary cancer syndrome (e.g., Li-Fraumeni Syndrome, Familial Melanoma)

Where it's running

  • National Institutes of Health Clinical Center
    Bethesda, Maryland, United States
    Recruiting
  • NIH National Cancer Institute - Shady Grove
    Rockville, Maryland, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.