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

Colon Cancer Clinical Trial

Official title:

Screening for Gynecologic Cancers Among Women With Hereditary Non-Polyposis Colon Cancer (HNPCC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508846
• Other study ID #: ID03-0211
• Status: Completed
• Phase: N/A
• First received: July 26, 2007
• Last updated: March 10, 2016
• Start date: May 2003
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colon Cancer
• Colorectal Neoplasms, Hereditary Nonpolyposis

Intervention

Behavioral:
• Questionnaire
Two-part telephone questionnaire lasting about 60 minutes total.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Responses to Questionnaire	Outcomes measuring demographics, surveillance behaviors, perceived risk, and cancer worries, screening supports/benefits and barriers.	7 Years	No

External Links

•   University of Texas MD Anderson Cancer Center Website