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Clinical Trial 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.


Clinical Trial Description

Background:

- This study is to continue the analysis begun on 09C0079 which was focused on identification of the genetic mutation associated with a new gastric polyposis syndrome, gastric adenocarcinoma and proximal polyposis of the stomach (GAPPS).

- GAPPS is an autosomal dominant gastric polyposis syndrome that confers a substantial risk for gastric adenocarcinoma.

Objective

- To specifically investigate families with clusters of cancer to determine if there is a potential familial genetic mutation specific to a particular cancer and if present, to compare these genetic abnormalities with individuals from the same family without cancer.

Eligibility:

- Participants must 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.

- Patients or family members of a patient with a family history of familial or hereditary solid organ cancers or a clinical suspicion for a familial cancer (these patients may show no evidence of disease at the time of enrollment).

- Participants must be 18 years of age or older as this study remains open only for participants in the genetic testing component of the 09-C-0079 protocol.

Design:

- This protocol is being opened only to continue same use of research that was approved under protocol 09-C-0079, to analyze the data for publication, and to provide participants with any results of clinical and analytic validity and clinical utility.

- Only patients previously enrolled on 09-C-0079 or family members of patients previously enrolled on 09-C-0079 will be enrolled on this study. All other research objectives of this study were completed under protocol 09-C-0079. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02565004
Study type Observational
Source National Institutes of Health Clinical Center (CC)
Contact
Status Enrolling by invitation
Phase N/A
Start date September 30, 2015
Completion date October 31, 2019

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