Multi-Organ Screening Recommendations in Patients With Lynch Syndrome

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT00582296

Collaborator

National Cancer Institute (NCI) (NIH), Albert Einstein College of Medicine (Other)

2,000

Enrollment

Locations

240

Anticipated Duration (Months)

250

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lynch Syndrome	Behavioral: questionnaires, telephone interview, optional blood drawn Behavioral: questionnaires, telephone interview and optional blood drawn

Study Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2004

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
1 multi-organ follow-up	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).
2 control follow-up	Behavioral: 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).

Arm

Intervention/Treatment

multi-organ follow-up

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).

control follow-up

Behavioral: questionnaires, telephone interview and optional blood drawn

Outcome Measures

Primary Outcome Measures

To assess adherence to comprehensive, multi-organ screening and risk-reducing behavior recommendations in patients with Lynch Syndrome. [conclusion of study]

Secondary Outcome Measures

To evaluate predictive factors for adherence to comprehensive, multi-organ screening and risk-reducing behavior recommendations. [conclusion of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memoral Sloan Kettering Basking Ridge	Basking Ridge	New Jersey	United States	07920
2	Memoral Sloan Kettering Monmouth (Consent Only)	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen (Consent Only)	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)	Commack	New York	United States	11725
5	Memoral Sloan Kettering Westchester (Consent Only)	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center Hauppauge (Consent Only)	Hauppauge	New York	United States	11788
7	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
8	Memorial Sloan Kettering Nassau (Consent only)	Uniondale	New York	United States	11553