Multi-Organ Screening Recommendations in Patients With Lynch Syndrome

NCT00582296 | Active Not Recruiting

• 1 other identifier: 04-144
• Study Type: observational
• Target: 1,530
• Locations: 1 country
• Sites: 8

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.

Conditions

Lynch Syndrome

Keywords

Lynch syndrome; 04-144

Outcome Measures

Primary Outcomes (1)

• To assess adherence to comprehensive, multi-organ screening and risk-reducing behavior recommendations in patients with Lynch Syndrome.

  conclusion of study

Secondary Outcomes (1)

• To evaluate predictive factors for adherence to comprehensive, multi-organ screening and risk-reducing behavior recommendations.

  conclusion of study

Study Arms (2)

1

multi-organ follow-up

Behavioral: questionnaires, telephone interview, optional blood drawn

2

control follow-up

Behavioral: questionnaires, telephone interview and optional blood drawn

Interventions

questionnaires, telephone interview, optional blood drawn BEHAVIORAL

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).

1

questionnaires, telephone interview and optional blood drawn BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seeking genetic counseling with or without genetic testing for colorectal cancer risk and/or suspected Lynch Syndrome will be recruited and offered enrollment during their first counseling visit at the Clinical Genetics Service at MSKCC

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Albert Einstein College of Medicine: collaborator
• Memorial Sloan Kettering Cancer Center: lead

Study Sites (8)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Consent Only)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Consent Only)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center Hauppauge (Consent Only)

Hauppauge, New York, 11788, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Consent only)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis

Interventions

Surveys and Questionnaires; Interviews as Topic

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Zsofia Stadler, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 28, 2007
• Study Start: December 1, 2004
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (8)