The Molecular Predisposition to Hereditary Nonpolyposis Colon Cancer (HNPCC) - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT01447199

Purpose

The goal of this study is to understand factors which may influence risk for colorectal and other cancers in families. These factors include genetic variability, in combination with diet and lifestyle. In order to achieve these goals, the investigators need to contact as many eligible participants as possible.

This study proposes to identify genetic risk factors that predispose to colorectal cancer (CRC). The focus of this study will be to understand the role of the mismatch repair genes responsible for Hereditary Non-polyposis Colorectal Cancer (HNPCC), i.e., hMSH2, hMLH1 and other mismatch repair genes and modifier genes in combination with diet and lifestyle in familial and de novo colon cancer cases. By examining the status of the mismatch repair genes in both normal and neoplastic tissues among mismatch repair gene mutation carriers, family members not carrying the mutation and non-HNPCC families, it will be possible to determine the role of the mismatch repair genes in the development of colon cancer within HNPCC families.

Condition	Intervention
Bladder Cancer Colorectal Cancer Endometrial Cancer Kidney Cancer Skin Cancer Uterus Cancer	Behavioral: Health and Diet Questionnaire

Study Type:	Observational
Study Design:	Observational Model: Family-Based Time Perspective: Prospective
Official Title:	The Molecular Predisposition to Hereditary Nonpolyposis Colon Cancer (HNPCC)

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer Lynch syndrome Help Me Understand Genetics

MedlinePlus related topics: Bladder Cancer Cancer Colorectal Cancer Kidney Cancer Skin Cancer Uterine Cancer

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Time to Onset for Colorectal Cancer [ Time Frame: Overall study period up to 15 years. ] [ Designated as safety issue: No ]
Primary endpoint is time to onset for colorectal cancer using Cox proportional hazard regression for determining the role that polymorphic variants of genes have on risk for development of HNPCC at an early age.

Biospecimen Retention: Samples With DNA

Participants will have a single sample (8-10 teaspoons) of blood collected at M. D. Anderson, depending upon current health status. In the case of individuals not coming to the clinic, a blood drawing kit will be sent to the participant's home, which will include instructions and a postage-paid return express mail envelope. If participant unable or unwilling to give a blood sample, saliva samples can be collected instead.

Estimated Enrollment:	2000
Study Start Date:	September 1994
Estimated Primary Completion Date:	September 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Gene Mutation Group with increased risk for developing colorectal and/or other cancers as the result of an inherited gene mutation, family history of cancer, or an early age of cancer onset.	Behavioral: Health and Diet Questionnaire Mailed questionnaires asking about foods eaten, cooking methods as well as overall health, and vitamin/medication use, taking several hours to complete. Other Name: Survey
No Cancer History Group with little/no personal or family history of cancer.	Behavioral: Health and Diet Questionnaire Mailed questionnaires asking about foods eaten, cooking methods as well as overall health, and vitamin/medication use, taking several hours to complete. Other Name: Survey
Spouses Spouses of those who may have an increased risk for developing colorectal and/or other cancers as the result of an inherited gene mutation, family history of cancer, or an early age of cancer onset, or little/no personal or family history of cancer.	Behavioral: Health and Diet Questionnaire Mailed questionnaires asking about foods eaten, cooking methods as well as overall health, and vitamin/medication use, taking several hours to complete. Other Name: Survey

Detailed Description:

Participants will have a single sample (8-10 teaspoons) of blood collected at M. D. Anderson, depending upon current health status. If participant unable or unwilling to give a blood sample, saliva samples can be collected instead.

Participants will be asked to answer a series of questions. These questions will ask about foods eaten either one year ago or one year before the first diagnosis of cancer. There will also be questions about cooking methods as well as overall health, and vitamin and medication use. Some of the questions are personal, but all answers will be kept strictly private. The questionnaire will be sent to homes via U.S. or express mail. It may take several hours to complete the survey, but there is no time limit on its completion.

Solid tumor material and colonoscopy specimens of normal tissue will be collected from participants requiring either colonoscopy or surgery for routine clinical reasons. The tumor fragments will be collected from specimens. Tissue required for a clinical pathology diagnosis will not be used for research purposes.

About 2,000 patients and family members will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Referrals from Departments of GI Oncology, GI Medicine and Nutrition, GI Surgery, GYN Oncology, Cancer Prevention and from the Genetic Counselors at UT MD Anderson Cancer Center, families and spouses.

Criteria

Inclusion Criteria:

All patients with a new referral for a diagnosis of colorectal cancer (adenocarcinoma) and/or HNPCC-related cancers at the UTMDACC will be considered potentially eligible for this study regardless of prior treatment.
Families maintained at the UTMDACC Hereditary Colon Cancer Registry that have a known germline mutation in a mismatch repair gene or contain two or more first degree relatives diagnosed with CRC and/or any HNPCC-related cancers, one of whom must be less than or equal to 50 years at diagnosis.
First-degree and more distant relatives of individuals diagnosed with CRC and/or any HNPCC-related cancers from either of the groups in 1 and 2 (above).
Any patient diagnosed with CRC and/or any HNPCC-related cancers less than or equal to 45 years of age.
Greater than or equal to age 18 at time of study.
Able to provide informed consent to participate in this study indicating that they are aware of the investigational nature, in keeping with the policies of this hospital.
Non-HNPCC quartets, defined as parents and two offspring who do not carry a mismatch repair gene mutation. These non-HNPCC quartets should have no personal history of cancer, nor cancer in any first degree relatives of the quartet members, nor history of trinucleotide repeat syndromes. Non-HNPCC parents in a quartet should be less than 34 years old at the time the offspring were born.

Exclusion Criteria:

Diagnosis of current major psychiatric disorder, per DSM-III-R (or DSM IV).
Age less than 18 years at time of enrollment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447199

Contacts

Contact: Patrick Lynch, MD, JD

713-794-5073

Locations

United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Patrick Lynch, MD, JD

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT01447199 History of Changes
Other Study ID Numbers:	DM94-060
Study First Received:	October 4, 2011
Last Updated:	April 20, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Bladder cancer
Colorectal cancer
Endometrial cancer
Kidney cancer
Skin cancer
Uterus cancer
Molecular Predisposition
Hereditary Nonpolyposis Colon Cancer
HNPCC
Molecular genetic testing

Gene mutations
Mutation analyses
Genetic polymorphisms
Family history of cancer
Early age of cancer onset
Little/no personal or family history of cancer
Spouses
Questionnaires
Blood sample
Saliva Sample

Additional relevant MeSH terms:

Urinary Bladder Neoplasms
Colonic Neoplasms
Endometrial Neoplasms
Skin Neoplasms
Carcinoma, Renal Cell
Kidney Neoplasms
Colorectal Neoplasms
Disease Susceptibility
Genetic Predisposition to Disease
Uterine Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms

Urinary Bladder Diseases
Urologic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Genital Neoplasms, Female
Uterine Diseases
Genital Diseases, Female
Skin Diseases
Adenocarcinoma
Carcinoma

ClinicalTrials.gov processed this record on May 23, 2012