NCT05350761Recruiting
Rare Tumors and Cancer Predisposition in Individuals and Families
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
Background: Some people may be prone to develop cancer for many reasons. Factors that affect their risk include the genes they inherit and the environment they live and work in. Researchers want to learn more about the natural history of cancer. Objective: To understand how genes and environmental factors can cause tumors and related conditions. Eligibility: People of any age who: Have tumors of an unusual type, pattern, or number Have a family member with a history of cancer Have been exposed to other factors that may increase their risk of cancer Design: This study does not involve treatment. Participants will answer questions about their personal and family medical history. They will give permission for researchers to see their medical records. Participants may be invited to the NIH Clinical Center for a physical exam. They may give samples including saliva, cheek cells, blood, urine, skin, and/or hair. Participants with cancer may give bone marrow. A needle will be used to remove a small sample of bone marrow from their hip bone. Participants may have a biopsy of their tumor. Participants may have other exams: Dental Ear, nose, and throat Eye Hearing Heart function and structure Participants with cancer may undergo more exams: A test of how much energy their body uses when resting A sleep study with a test that measures brain electrical activity. They will have sensors attached to their body while they sleep overnight in a lab. Imaging scans, such as CT, MRI, a test to measure how dense their bones are (DEXA), and ultrasound. Participants will have their genes tested. A counsellor will help them understand the results. Participants will be followed until at least 2035.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 26 Apr 2022
- Start date
- 10 Mar 2023
- Primary completion date
- 31 Dec 2035
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Childhood cancers
- NCT number
- NCT05350761
What you commit to
- Study type: Observational
- Planned participants: 500
- From 10 Mar 2023 to the primary completion date, 31 Dec 2035
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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:
- Referred families who are eligible for other CGB protocols that are specific to a hereditary cancer syndrome (e.g., Li-Fraumeni Syndrome, Familial Melanoma)
Other
- Affected: An individual who meets any of the following criteria will be excluded from participation in this study:
- Referred individuals for whom reported diagnoses cannot be verified
- Inability of the participant or LAR to understand and be willing to sign a written informed consent document.
- Referred families for whom reported diagnoses cannot be verified
- Inability of the participant or LAR to understand and be willing to sign a written informed consent document.
Criteria the registry did not label
- 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:
- Personal medical history of neoplasia of an unusual type, pattern, or number; or,
- 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.).
- 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.
- 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:
- Family medical history of neoplasia of an unusual type, pattern, or number; or,
- 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.).
- 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.
- 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.
Age in the registry: 1 year to 99 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
| NIH National Cancer Institute - Shady Grove Coordinator of this site? Confirm its status | Rockville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.