Multi-Organ Screening Recommendations in Patients With Lynch Syndrome
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ClinicalTrials.gov Identifier: NCT00582296 |
Recruitment Status :
Recruiting
First Posted : December 28, 2007
Last Update Posted : March 25, 2022
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Condition or disease | Intervention/treatment |
---|---|
Lynch Syndrome | Behavioral: questionnaires, telephone interview, optional blood drawn Behavioral: questionnaires, telephone interview and optional blood drawn |
Study Type : | Observational |
Estimated 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 : | December 2004 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | December 2024 |

Group/Cohort | 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). |
- To assess adherence to comprehensive, multi-organ screening and risk-reducing behavior recommendations in patients with Lynch Syndrome. [ Time Frame: conclusion of study ]
- To evaluate predictive factors for adherence to comprehensive, multi-organ screening and risk-reducing behavior recommendations. [ Time Frame: conclusion of study ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00582296
Contact: Zsofia Stadler, MD | 646-888-4083 | ||
Contact: Kenneth Offit, MD | 646-888-4039 |
United States, New Jersey | |
Memoral Sloan Kettering Basking Ridge | Recruiting |
Basking Ridge, New Jersey, United States, 07920 | |
Contact: Zsofia Stadler, MD 646-888-4083 | |
Memoral Sloan Kettering Monmouth (Consent Only) | Recruiting |
Middletown, New Jersey, United States, 07748 | |
Contact: Zsofia Stadler, MD 646-888-4083 | |
Memorial Sloan Kettering Bergen (Consent Only) | Recruiting |
Montvale, New Jersey, United States, 07645 | |
Contact: Zsofia Stadler, MD 646-888-4083 | |
United States, New York | |
Memorial Sloan Kettering Cancer Center @ Commack (Consent Only) | Recruiting |
Commack, New York, United States, 11725 | |
Contact: Zsofia Stadler, MD 646-888-4083 | |
Memoral Sloan Kettering Westchester (Consent Only) | Recruiting |
Harrison, New York, United States, 10604 | |
Contact: Zsofia Stadler, MD 646-888-4083 | |
Memorial Sloan Kettering Cancer Center Hauppauge (Consent Only) | Recruiting |
Hauppauge, New York, United States, 11788 | |
Contact: Zsofia Stadler, MD 646-888-4083 | |
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 | |
Memorial Sloan Kettering Nassau (Consent only) | Recruiting |
Uniondale, New York, United States, 11553 | |
Contact: Zsofia Stadler, MD 646-888-4083 |
Principal Investigator: | Zsofia Stadler, MD | Memorial Sloan Kettering Cancer Center |
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00582296 |
Other Study ID Numbers: |
04-144 |
First Posted: | December 28, 2007 Key Record Dates |
Last Update Posted: | March 25, 2022 |
Last Verified: | March 2022 |
Lynch syndrome 04-144 |
Colorectal Neoplasms, Hereditary Nonpolyposis Syndrome Disease Pathologic Processes 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 DNA Repair-Deficiency Disorders Metabolic Diseases |