Rare Tumors and Cancer Predisposition in Individuals and Families

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05350761
Status
Recruiting
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Conditions

  • Cancer
  • Environment
  • Genetic Predisposition to Cancer
  • Hereditary Neoplasms

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Mar 10, 2023
Status verified
May 2026
Primary completion
Dec 31, 2035
Completion
Dec 31, 2035

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Clinical Center Cohort
    includes Proband, Other carriers in family, Family Controls
  • Arm: Field Cohort
    includes Proband, Other carriers in family, Family Controls

Primary Outcome Measure

Defining the natural history of familial cancers and susceptibility states over multiple generations, identifying cancer susceptibility genes, and assessing gene-environment and gene-gene interactions [ Time Frame: Ongoing ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-
NIH National Cancer Institute - Shady GroveRockvilleMaryland20850-

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By research site
National Institutes of Health Clinical Center· Bethesda, MDNIH National Cancer Institute - Shady Grove· Rockville, MD

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