- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00341575
Psychosocial Aspects of Genetic Testing for Hereditary Nonpolyposis Colon Cancer
Psychosocial Aspects of Genetic Testing for HNPCC
This study, conducted by NHGRI and the M.D. Anderson Cancer Center in Houston, Texas, will develop statistical approaches for modeling family social structure and apply these models to explore the role of family social structure in participation in genetic testing and counseling, disclosure of test results and adjustment to risk status. With recent genetic advances and the ability to test for hereditary illnesses, methods that provide an understanding of the family social structure and how that structure affects the dissemination of genetic risk information are increasingly important.
The data for this study were collected by the M.D. Anderson Cancer Center as part of a study on family communication and family functioning with regard to genetic testing for hereditary nonpolyposis colon cancer (HNPCC). Relatives of people with HNPCC are more likely than the general population to get colon cancer and other types of cancer if they have inherited the gene alteration (mutation) that predisposes to the disease. This alteration can be passed on from a parent to some or all of his or her children.
In the M.D. Anderson Cancer Center study, telephone interviews were conducted with 80 adult members of 16 extended families with a known gene alteration predisposing for HNPCC. These participants included people who had been diagnosed with an HNPCC syndrome cancer, their unaffected family members who were at risk of carrying a gene mutation for HNPCC, and their spouses. Participants were interviewed about their feelings, moods, coping style, and relationships with their spouse, relatives, and friends, about their willingness to have genetic testing, and about their feelings and beliefs about colon cancer, cancer screening and genetic testing and counseling. Some participants were asked about their family communication style and how the family coped with the idea of genetic testing and with the results, if testing was done.
The information obtained from the current study may help facilitate family participation, communication and psychological adjustment regarding risk information about genetic diseases.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Human Genome Research Institute (NHGRI), 9000 Rockville Pike
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
Signed consent
Ability to speak, read, and write English
Diagnosis of adenocarcinoma of the colon or rectum (CRC) patients who test positive for HNPCC mutations, or adult FDR of HNPCC mutation carriers, or spouses of CRC patient or FDR of HNPCC mutation carriers.
EXCLUSION CRITERIA
Presence of current major psychiatric disorder as defined by the
DSM-IV, 2) age less than 18 years.
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- Burke W, Daly M, Garber J, Botkin J, Kahn MJ, Lynch P, McTiernan A, Offit K, Perlman J, Petersen G, Thomson E, Varricchio C. Recommendations for follow-up care of individuals with an inherited predisposition to cancer. II. BRCA1 and BRCA2. Cancer Genetics Studies Consortium. JAMA. 1997 Mar 26;277(12):997-1003.
- Claes E, Denayer L, Evers-Kiebooms G, Boogaerts A, Philippe K, Tejpar S, Devriendt K, Legius E. Predictive testing for hereditary nonpolyposis colorectal cancer: subjective perception regarding colorectal and endometrial cancer, distress, and health-related behavior at one year post-test. Genet Test. 2005 Spring;9(1):54-65. doi: 10.1089/gte.2005.9.54.
- Claes E, Denayer L, Evers-Kiebooms G, Boogaerts A, Legius E. Predictive testing for hereditary non-polyposis colorectal cancer: motivation, illness representations and short-term psychological impact. Patient Educ Couns. 2004 Nov;55(2):265-74. doi: 10.1016/j.pec.2003.11.002.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Metabolic Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Genetic Diseases, Inborn
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Colorectal Neoplasms
- Neoplastic Syndromes, Hereditary
- DNA Repair-Deficiency Disorders
- Colorectal Neoplasms, Hereditary Nonpolyposis
- Colonic Neoplasms
Other Study ID Numbers
- 999905249
- 05-HG-N249
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HNPCC
-
National Human Genome Research Institute (NHGRI)Completed
-
Universitaire Ziekenhuizen KU LeuvenCompletedLynch Syndrome | Hereditary Non-polyposis Colon Carcinoma | HNPCCBelgium
-
Vejle HospitalCompletedColorectal Cancer | Lynch Syndrome | HNPCCDenmark
-
Vejle HospitalCompletedColorectal Cancer | Lynch Syndrome | HNPCCDenmark
-
University of PennsylvaniaEpigenomics, IncCompletedColorectal Cancer | Lynch Syndrome | Familial Adenomatous Polyposis | Map Syndrome | HnpccUnited States
-
White Plains HospitalRecruitingPancreatic Cancer | Pancreatic Adenocarcinoma | Lynch Syndrome | Pancreas Cancer | HNPCC | Familial Pancreatic Cancer | Hereditary Pancreatitis | BRCA 1/2 | FAMMM | Familial Atypical Multiple Mole Melanoma | Peutz Jeghers SyndromeUnited States