Multi-Organ Screening Recommendations in Patients With Lynch Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
Albert Einstein College of Medicine of Yeshiva University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00582296
First received: December 21, 2007
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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 Intervention
Lynch Syndrome
Behavioral: questionnaires, telephone interview, optional tube of blood drawn
Behavioral: questionnaires, telephone interview and optional tub of blood drawn

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adherence to Comprehensive, Multi-Organ Screening Recommendations in Patients With Lynch Syndrome

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To assess adherence to comprehensive, multi-organ screening and risk-reducing behavior recommendations in patients with Lynch Syndrome. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate predictive factors for adherence to comprehensive, multi-organ screening and risk-reducing behavior recommendations. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: December 2004
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
multi-organ follow-up
Behavioral: questionnaires, telephone interview, optional tube of 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 tub of 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582296

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

Locations
United States, New York
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         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Albert Einstein College of Medicine of Yeshiva University
Investigators
Principal Investigator: Zsofia Stadler, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00582296     History of Changes
Other Study ID Numbers: 04-144
Study First Received: December 21, 2007
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Lynch syndrome
04-144

Additional relevant MeSH terms:
Syndrome
Colorectal Neoplasms, Hereditary Nonpolyposis
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

ClinicalTrials.gov processed this record on September 18, 2014