Collecting Information From Patients and Family Members With Hereditary Colorectal Cancer Syndromes or Who Are at High Risk of Developing Colorectal Cancer

NCT ID: NCT00675636

Last Updated: 2017-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

730 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2017-06-30

Brief Summary

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RATIONALE: Gathering medical and family history information from patients and family members may help doctors better understand hereditary colorectal cancer and hereditary polyposis syndrome and identify patients at high risk of developing hereditary colorectal cancer.

PURPOSE: This research study is collecting information from patients and family members with hereditary colorectal cancer or polyposis syndrome or who are at high risk of developing hereditary colorectal cancer.

Detailed Description

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OBJECTIVES:

Primary

* To identify patients and their family members who have either hereditary colorectal cancer or polyposis syndrome or are at high risk for developing hereditary colorectal cancer.

Secondary

* To establish a tissue and data repository that will be used to further research in hereditary colorectal cancer syndromes.

OUTLINE: Data is collected on patients and their families for inclusion in a hereditary colorectal cancer registry. Registry data is entered into a secure database that includes information on patient demographics and medical and family cancer history. The information collected will be used to formulate screening and surveillance recommendations, to further knowledge of hereditary colorectal cancer, and to facilitate cancer research. Registry data will also be used to improve the quality of current standard of care through timely tracking and notification of patients for follow-up care, identification of registry participants at high risk for developing an inherited form of colon cancer, and by serving as a resource for future research.

Registry patients may undergo optional blood, urine, and/or sputum sample collection for inclusion in the tissue repository. Tissue samples from a previous biopsy may also be obtained. Samples will be stored for future research studies.

Conditions

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Colorectal Cancer Hereditary Non-polyposis Colon Cancer Precancerous Condition

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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study of socioeconomic and demographic variables

database, no intervention

Intervention Type OTHER

evaluation of cancer risk factors

database, no intervention

Intervention Type PROCEDURE

study of high risk factors

database, no intervention

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Meets any of the following criteria:

* Patients and family members with a known hereditary colorectal cancer or polyposis syndrome
* Patients who meet Amsterdam I, II, or Bethesda criteria
* Patients with a family history suggestive of a hereditary colorectal or polyposis syndrome
* Patients diagnosed with colorectal cancer at \< 50 years old
* Patients are identified through surgical, oncological, gynecological, and gastrointestinal programs, as well as outside referrals, self referral, and the Vanderbilit Tumor Registry

PATIENT CHARACTERISTICS:

* See Disease Characteristics

PRIOR CONCURRENT THERAPY:

* Not specified
Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Molly Cone

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Wise, MD

Role: STUDY_CHAIR

Vanderbilt-Ingram Cancer Center

Locations

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Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, United States

Site Status

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, United States

Site Status

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA068485

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VU-VICC-GI-0721

Identifier Type: -

Identifier Source: secondary_id

VU-VICC-061182

Identifier Type: -

Identifier Source: secondary_id

CDR0000587344

Identifier Type: -

Identifier Source: org_study_id

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