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Trial record 17 of 72 for:    colon cancer AND Colorectal Neoplasms | ( Map: New Jersey, United States )

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 : July 23, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Albert Einstein College of Medicine
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date December 21, 2007
First Posted Date December 28, 2007
Last Update Posted Date July 23, 2019
Actual Study Start Date December 2004
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 17, 2014)
To assess adherence to comprehensive, multi-organ screening and risk-reducing behavior recommendations in patients with Lynch Syndrome. [ Time Frame: conclusion of study ]
Original Primary Outcome Measures
 (submitted: December 21, 2007)
To assess adherence to comprehensive, multi-organ screening and risk-reducing behavior recommendations in HNPCC patients. [ Time Frame: conclusion of study ]
Change History Complete list of historical versions of study NCT00582296 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 21, 2007)
To evaluate predictive factors for adherence to comprehensive, multi-organ screening and risk-reducing behavior recommendations. [ Time Frame: conclusion of study ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multi-Organ Screening Recommendations in Patients With Lynch Syndrome
Official Title Adherence to Comprehensive, Multi-Organ Screening Recommendations in Patients With Lynch Syndrome
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Lynch Syndrome
Intervention
  • 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).
  • 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).
Study Groups/Cohorts
  • 1
    multi-organ follow-up
    Intervention: Behavioral: questionnaires, telephone interview, optional blood drawn
  • 2
    control follow-up
    Intervention: Behavioral: questionnaires, telephone interview and optional blood drawn
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 10, 2017)
2000
Original Estimated Enrollment
 (submitted: December 21, 2007)
145
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Zsofia Stadler, MD 646-888-4083
Contact: Kenneth Offit, MD 646-888-4039
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00582296
Other Study ID Numbers 04-144
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor Memorial Sloan Kettering Cancer Center
Collaborators
  • National Cancer Institute (NCI)
  • Albert Einstein College of Medicine
Investigators
Principal Investigator: Zsofia Stadler, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date July 2019