Clinical Genetics Branch Eligibility Screening Survey

Not yet recruiting

• Conditions: Melanoma; Li-Fraumeni Syndrome; Pulmonary Blastoma; Chordoma; Congenital Bone Marrow Failure Syndromes; Costello Syndrome; Fanconi Anemia; CFC Syndrome (CFCS); Legius Syndrome; RASopathies

• Registration Number: NCT07005297
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

Background:

Clinical Genetics Branch (CGB) researchers study individuals and populations at high genetic risk of cancer in order to improve our understanding of cancer and to improve cancer care. There are currently 8 open clinical genetics studies at the CGB.

* 001109: Defining the Natural History of Squamous Cell Carcinoma in Fanconi anemia (SCC Screening in FA).

* 20C0107: Clinical, Genetic, and Epidemiologic Study of Children and Adults with RASopathies (RASopathies Study).

* 02C0052: Etiologic Investigation of Cancer Susceptibility in Inherited Bone Marrow Failure Syndromes: A Natural History Study (Cancer in Bone Marrow Failure).

* 11C0255: Clinical, Epidemiologic, and Genetic Studies of Li-Fraumeni Syndrome (Li Fraumeni Syndrome Study).

* 11C0034: DICER1-Related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study (Pleuropulmonary Blastoma).

* 02C0211: Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma (Melanoma-Prone Families).

* 78C0039: Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Cancer (Cancer-prone families study).

* 10CN188: Genetic Clues to Chordoma Etiology: A Protocol to Identify Sporadic Chordoma Patients for Studies of Cancer-susceptibility Genes (Sporadic Chordoma Study).

Objective:

To find people to participate in active CGB cancer research studies.

Eligibility:

People of any age who meet the eligibility criteria for one of the open CGB cancer research studies. This typically involves a personal or family history of certain cancers that are being studied by researchers at CGB.

Design:

Participants will fill out a screening questionnaire to determine if they are eligible to participate in one or more CGB clinical genetics studies. The survey asks about personal health history, including cancer; their family history; and genetic testing results and takes 15 to 20 minutes.

Each study has its own eligibility criteria. Survey respondents will respond with study (or studies) that are interested in participating in, and the relevant study team(s) will review the screener to determine eligibility to participate in the study. Participants who are determine to be eligible for a study based on their screener will be contacted by the respective study team to learn more about the study and to consent to enroll in the study if they choose to do so. Participants who consent to enroll in a study will be asked to provide medical records and samples such as blood, saliva, or other tissues and to participate in activities such as phone interviews or surveys. They may be invited for evaluations at the clinical center. Every study activity is voluntary. None of the studies provide treatments. Participants may be contacted to consider enrolling in future studies.

Detailed Description

Study Description:

This protocol will be utilized for the creation and management of an eligibility screening survey for patients who are interested in enrolling in a study being conducted by the Clinical Genetics Branch (CGB).

Objectives:

The primary objective of this protocol is to establish a database of eligibility data collected from prospective participants who have completed an eligibility screening survey. This database, managed by the CGB, will serve as a critical resource for assessing participant eligibility for enrollment in various CGB studies.

Study Timeline

• Status Verified: 2025-06-02
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-04
• Study First Posted: 2025-06-05
• Last Update Submitted: 2025-06-05
• Last Update Posted: 2025-06-06
• Study Start: 2025-06-11
• Primary Completion: 2035-01-01
• Study Completion: 2036-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Eligible Participants Identified	Duration of the protocol	The total count of individuals who qualify for a CGB study

Trial Locations

Locations (1)

National Cancer Institute; 🇺🇸 Rockville, Maryland, United States