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Screening for Gynecologic Cancers in Hereditary Nonpolyposis Colorectal Cancer (HNPCC) Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00508846
First received: July 26, 2007
Last updated: September 26, 2012
Last verified: September 2012
History of Changes
  Purpose

Among women with HNPCC, this study will assess:

  1. Knowledge of screening recommendations for endometrial and ovarian cancers.
  2. Perceived risk and cancer worries regarding endometrial, ovarian and colorectal cancers.
  3. Adherence to screening recommendations for endometrial, ovarian and colon cancers.
  4. Perceived benefits,supports and barriers to endometrial and ovarian cancer screening.
  5. Patterns of communication about endometrial and ovarian cancer risk within families with HNPCC and with health care providers.
  6. Patient preferences for potential cancer screening and cancer prevention strategies related to HNPCC-associated cancers.

Condition Intervention
Colon Cancer
 Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Screening for Gynecologic Cancers Among Women With Hereditary Non-Polyposis Colon Cancer (HNPCC)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Patient Responses to Questionnaire [ Time Frame: 7 Years ] [ Designated as safety issue: No ]
    Outcomes measuring demographics, surveillance behaviors, perceived risk, and cancer worries, screening supports/benefits and barriers.


Estimated Enrollment: 95
Study Start Date: May 2003
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HNPCC Patients Behavioral: Questionnaire
Two-part telephone questionnaire lasting about 60 minutes total.
Other Name: Survey

Detailed Description:

Women who are at risk for HNPCC will be recruited to participate in this pilot study.

Women will be invited to participate in the study either through a mailed invitation or during a visit to M.D. Anderson for clinical services or for research purposes.

Women who wish to participate in the study will complete an informed consent, and will subsequently schedule an appointment with a research coordinator to complete the study questionnaire by telephone.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women, age 25 years of age or older, diagnosed with Hereditary Non-Polyposis Colon Cancer (HNPCC).

Criteria

Inclusion Criteria:

  1. Being female
  2. Being 25 years of age or older
  3. Having an HNPCC-predisposing mutation and/or having a family history of cancer that meets the Amsterdam or Amsterdam II criteria for HNPCC

Exclusion Criteria:

  1. Persons who have tested negative for a known HNPCC-predisposing mutation in their family
  2. Persons who have no family HNPCC mutation and have not met the Amsterdam I/II criteria
  3. Being younger than 25 years old
  4. Note: Women who have had a prior history of colorectal cancer or polyps will not be excluded unless they meet one of the above exclusion criteria.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508846

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Susan Peterson, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
The University of Texas M.D.Anderson Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00508846     History of Changes
Other Study ID Numbers: ID03-0211
Study First Received: July 26, 2007
Last Updated: September 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Hereditary Non-Polyposis Colon Cancer
Gynecologic Cancers
Genetic Counseling
 Questionnaire
Survey
HNPCC

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 18, 2013