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NCT00582296 Clinical Trial

Multi-Organ Screening Recommendations in Patients With Lynch Syndrome

Lynch Syndrome Clinical Trial

Official title:
Adherence to Comprehensive, Multi-Organ Screening Recommendations in Patients With Lynch Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00582296
Other study ID # 04-144
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 2004
Est. completion date December 2025

Study information
Verified date March 2024
Source Memorial Sloan Kettering Cancer Center
Contact Zsofia Stadler, MD
Phone 646-888-4083
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Lynch Syndrome 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.

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• questionnaires, telephone interview, optional 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 Participants may also donate an additional blood, serum, saliva, urine, or stool sample for research, (in addition to the blood drawn for clinical testing) or for the sole purpose of research testing (in absence of clinical testing or prior external testing).
• questionnaires, telephone interview and optional 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 Participants may also donate an additional blood, serum, saliva, urine, or stool sample for research, (in addition to the blood drawn for clinical testing) or for the sole purpose of research testing (in absence of clinical testing or prior external testing).

Locations
Country Name City State
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Memorial Sloan Kettering Cancer Center @ Commack (Consent Only) Commack New York
United States Memorial Sloan Kettering Westchester (Consent Only) Harrison New York
United States Memorial Sloan Kettering Cancer Center Hauppauge (Consent Only) Hauppauge New York
United States Memorial Sloan Kettering Monmouth (Consent Only) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (Consent Only) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Nassau (Consent only) Uniondale New York

Sponsors (3)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Albert Einstein College of Medicine, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To assess adherence to comprehensive, multi-organ screening and risk-reducing behavior recommendations in patients with Lynch Syndrome. conclusion of study
Secondary To evaluate predictive factors for adherence to comprehensive, multi-organ screening and risk-reducing behavior recommendations. conclusion of study
See also
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Active, not recruiting NCT02912559 - Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair Phase 3
Recruiting NCT04978350 - Overcoming Barriers to the Uptake of Cascade Screening for Lynch Syndrome: Workbook Feasibility Study N/A
Active, not recruiting NCT03832985 - Pediatric Reporting of Adult-Onset Genomic Results Early Phase 1
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Completed NCT02570516 - NBI Versus Indigo Carmine During Colonoscopy in Lynch Syndrome N/A
Completed NCT01823471 - I-Scan For Colon Polyp Detection In HNPCC N/A
Recruiting NCT02813824 - Effect of Chemoprevention by Low-dose Aspirin of New or Recurrent Colorectal Adenomas in Patients With Lynch Syndrome Phase 3
Recruiting NCT05078866 - Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients Phase 1/Phase 2
Recruiting NCT03744962 - MSI in Circulatory DNA of Endometrial Cancer
Recruiting NCT04711434 - PD-1 Antibody for The Prevention of Adenomatous Polyps and Second Primary Tumors in Lynch Syndrome Patients Phase 3
Completed NCT04131062 - Trial to Compare eConsent With Standard Consent Among Prospective Biobank Participants N/A

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