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Multi-Organ Screening Recommendations in Patients With Lynch Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00582296
Recruitment Status : Recruiting
First Posted : December 28, 2007
Last Update Posted : March 24, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Albert Einstein College of Medicine
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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
Lynch Syndrome Behavioral: questionnaires, telephone interview, optional blood drawn Behavioral: questionnaires, telephone interview and optional blood drawn

Study Design
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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 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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).


Outcome Measures
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Primary Outcome Measures :
  1. To assess adherence to comprehensive, multi-organ screening and risk-reducing behavior recommendations in patients with Lynch Syndrome. [ Time Frame: conclusion of study ]

Secondary Outcome Measures :
  1. To evaluate predictive factors for adherence to comprehensive, multi-organ screening and risk-reducing behavior recommendations. [ Time Frame: conclusion of study ]

Eligibility Criteria
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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
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
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 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
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Information from the National Library of Medicine

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


Contacts
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Contact: Zsofia Stadler, MD 646-888-4083
Contact: Kenneth Offit, MD 646-888-4039

Locations
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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      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Albert Einstein College of Medicine
Investigators
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Principal Investigator: Zsofia Stadler, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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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 24, 2020
Last Verified: March 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
Lynch syndrome
04-144
Additional relevant MeSH terms:
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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