Multi-Organ Screening Recommendations in Hereditary Non-Polyposis Colorectal Cancer (HNPCC) Patients
This study is currently recruiting participants.
Verified April 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborators:
Albert Einstein College of Medicine of Yeshiva University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00582296
First received: December 21, 2007
Last updated: April 26, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to examine how people with a family history of colon cancer and other related cancers respond to recommendations for cancer screening after genetic counseling. The purpose of your participation would be to help us learn more about whether people with a personal and/or family history of colorectal cancer and other cancers follow cancer screening recommendations.
| Condition | Intervention |
|---|---|
|
Hereditary Nonpolyposis Colorectal Cancer Colon Cancer |
Behavioral: questionnaires, telephone interview, optional tube of blood drawn Behavioral: questionnaires, telephone interview and optional tub of blood drawn |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Adherence to Comprehensive, Multi-Organ Screening Recommendations in Hereditary Non-Polyposis Colorectal Cancer (HNPCC) Patients |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- To assess adherence to comprehensive, multi-organ screening and risk-reducing behavior recommendations in HNPCC patients. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate predictive factors for adherence to comprehensive, multi-organ screening and risk-reducing behavior recommendations. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | December 2004 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
multi-organ follow-up
|
Behavioral: questionnaires, telephone interview, optional tube of blood drawn
Initial CGS Visit (All Prospective Participants)Clinical assessment (screening, family & personal history of CA, surgeries) 6 Month Follow-Up Phone Interview (Prospective) Follow-Up Questionnaire (prospective and retrospective) Retrospective Initial Interview
|
|
2
control follow-up
|
Behavioral: questionnaires, telephone interview and optional tub of blood drawn
Initial CGS Visit (All Prospective Participants)Clinical assessment (screening, family & personal history of CA, surgeries) 6 Month Follow-Up Phone Interview (Prospective) Follow-Up Questionnaire (prospective and retrospective) Retrospective Initial Interview
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients seeking genetic counseling with or without genetic testing for colorectal cancer risk and/or suspected HNPCC will be recruited and offered enrollment during their first counseling visit at the Clinical Genetics Service at MSKCC
Criteria
Inclusion Criteria:
- A patient will be eligible for enrollment if he/she is self-referred or physician-referred for genetic counseling at Memorial Sloan-Kettering Cancer Center's (MSKCC) Clinical Genetics Service due to a concern about increased risk for colon cancer or;
- An individual who presents for genetic counseling at MSKCC's Clinical Genetics Service after undergoing genetic testing at an outside institution with a documented mutation in any gene associated with HNPCC or;
- An individual who in the context of genetic counseling has received stricter colorectal and/or gynecologic screening recommendations than that of the general population regardless of genetic test results.
- DNA of patients who have been consented to protocol 93-102 ("Ascertainment of Peripheral Blood or Saliva Samples for Genetic Epidemiology Studies of Familial Cancers"), who meet the eligibility criteria listed above, will also be eligible for inclusion in this study.
Exclusion Criteria:
- Patients will be excluded from this study if: he/she has physical, cognitive or psychiatric conditions that interfere with ability to give meaningful informed consent; he/she cannot read, write or communicate in English; he/she is less than 18 years of age; he/she has received a diagnosis of FAP.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00582296
Contacts
| Contact: Zsofia Stadler, MD | 646-888-4615 | |
| Contact: Kenneth Offit, MD | 646-735-8160 |
Locations
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Zsofia Stadler, MD 646-888-4615 | |
| Contact: Kenneth Offit, MD 646-735-8160 | |
| Principal Investigator: Zsofia Stadler, MD | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Albert Einstein College of Medicine of Yeshiva University
Investigators
| Principal Investigator: | Zsofia Stadler, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00582296 History of Changes |
| Other Study ID Numbers: | 04-144 |
| Study First Received: | December 21, 2007 |
| Last Updated: | April 26, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Lynch syndrome |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn DNA Repair-Deficiency Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013