The Molecular Predisposition to Hereditary Nonpolyposis Colon Cancer (HNPCC)
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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) |
- 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 |
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.
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| Contact: Patrick Lynch, MD, JD | 713-794-5073 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Patrick Lynch, MD, JD | UT MD Anderson Cancer Center |
More Information
Additional Information:
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: | March 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Family history of cancer Little/no personal or family history of cancer 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 Early age of cancer onset 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 Adenoma 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 |
ClinicalTrials.gov processed this record on May 23, 2013