Clinical and Laboratory Analysis of Familial Cancer

NCT02565004 | Completed

• 2 other identifiers: 15020415-C-0204
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Background: DNA makes up the instruction book for people s cells. Cancer is a disease caused by DNA changes that build up and affect cell function. Researchers want to learn more about what may cause cancer by testing the DNA of people with the disease and their family members. Objective: To find DNA changes that may be inherited and may cause or influence whether a person gets cancer. To study families with clusters of cancer to find out if there is a DNA mutation specific to certain cancers. Eligibility: People 18 years of age and older who: Participated in the familial genetic part of NIH study 09-C-0079, a previous study or had family members enrolled in this study Design: Participants may have been screened in the previous study. They will give permission for researchers to use their data and their tissue or blood samples collected in the study. Participants may give blood samples. At each stage of testing, participants will meet with a genetics health care provider. The provider will explain the tests and answer questions. If researchers find a DNA change that might increase the risk for cancer or other health issues, they will confirm this result in a testing lab. This will require a blood sample. Participants personal DNA data and health information will be put in a database for research purposes.

Conditions

Cancer

Keywords

Genetic; Sample Collection; Natural History

Outcome Measures

Primary Outcomes (1)

• investigate relationship of familial genetic mutation to a particular cancer

  linkage analysis performed for familial clustering of malignant and pre-malignant disease in families

  1 year

Secondary Outcomes (1)

• To assess the phenotype of Gastric Adenocarcinoma and Proximal Polyposis of the Stomach (GAPPS)

  1-2 years

Study Arms (2)

1

Patients who were enrolled on protocol 09-C-0079, or family members of patients who were enrolled on protocol 09-C-0079

2

Individuals found to harbor a germline APC promoter 1B variant not previously enrolled in Cohort l.

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants or family members of participants previously enrolled on the familial genetic analysis arm of NIH study 09-C-0079 (must be 10 years old or older, may be pregnant)

You may qualify if:

• Participants must meet one of the following:
• Have been previously enrolled on the familial genetic analysis arm of NIH study 09-C-0079; OR
• Be family members of patients previously enrolled on the familial genetic analysis arm of 09-C-0079; OR
• Have a documented pathogenic germline APC promotor 1B variant from a CLIA approved laboratory.
• Participants must be 10 years of age or older

You may not qualify if:

• Inability to provide informed consent.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Neoplasms

Study Officials

• Kathleen Calzone, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 1, 2015
• Study Start: September 28, 2015
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: May 16, 2022

Record last verified: 2022-05

Locations

US (1)