Trial record 10 of 287 for:    colorectal cancer AND (women OR woman OR female)

Women Who Are At Risk Or May Have Lynch Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00508573
First received: July 26, 2007
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

The goal of this study is to create a registry of information about women who have or are at risk for Lynch syndrome, in order to study gynecologic cancer risks.

Objectives:

  1. To create a registry of women who have or are at risk for Lynch syndrome, and to monitor and document their follow-up prospectively.
  2. To have a repository of clinical data and tissue specimens that will serve as a secure archive for future research.

Condition Intervention
Hereditary Nonpolyposis Colorectal Cancer
Lynch Syndrome
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Registry for Women Who Are At Risk Or May Have Lynch Syndrome

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Women Participating in Registry [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Leftover tissue samples will be collected from surgery performed. These samples will be stored and used to perform molecular studies to characterize Lynch syndrome tumors.


Estimated Enrollment: 1000
Study Start Date: May 2007
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Lynch Syndrome Registry
Patient that has or is at risk for Lynch Syndrome.
Behavioral: Questionnaire
Follow-up questionnaire done once a year for five years.
Other Name: Survey

Detailed Description:

Lynch Syndrome:

In women with hereditary non-polyposis colorectal cancer syndrome (HNPCC), also called Lynch syndrome, the lifetime risk for endometrial cancer increases to 40-60%, and the risk for ovarian cancer increases to 12%.

Study Procedures:

If you agree to take part in this study, basic medical and family information will be collected. You will be asked to fill out a baseline (starting) questionnaire, which will ask personal information such as age, ethnic background, medical and family history, and health habits. All information will be kept confidential. Some information may be gathered from your medical record. It should take about 30 minutes to complete this questionnaire.

Once a year for 5 years, you will be asked to complete a follow-up questionnaire. The follow-up questionnaire provides researchers with an opportunity to study possible health issues and/or changes that may have occurred since your last visit. This questionnaire should only take about 15 -20 minutes to complete.

If you have a history of endometrial or ovarian cancer, or develop endometrial or ovarian cancer while on study, researchers will collect copies of the diagnostic and surgery reports from your medical record and will ask you to fill out an additional questionnaire about symptoms of endometrial cancer. This should only take about 15 minutes to complete.

Researchers will also collect several leftover tissue samples from your surgery if you have had surgery. These samples will be stored and used to perform molecular studies to characterize Lynch syndrome tumors. The samples will be kept securely in a lab at MD Anderson.

Before your leftover tissue samples can be used for research, the people doing the research must get specific approval from the Institutional Review Board (IRB) of MD Anderson. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. All research done at MD Anderson, including research involving your leftover tissue samples must first be approved by the IRB.

Length of Study:

At the end of the study, you may be invited to participate in a follow-up study. During your participation in this registry study, researchers will inform you about related studies for which you might be eligible. You will have the option to take part or not to take part in them. Your participation in this study will be over after 5 years.

This is an investigational study. Up to 1000 patients will take part in this study. All patients will be enrolled at MD Anderson.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women, 18 years or older, that have or are at risk for Lynch Syndrome.

Criteria

Inclusion Criteria:

  1. Women who meet one or more of the following criteria:

    A. Lynch syndrome mutation, including those at risk for cancer, those who have had cancer, and those who have had prophylactic surgery.

    B. Family history meets Amsterdam II criteria, defined as the following: At least 3 relatives with an HNPCC-associated cancer (colorectal.endometrial cancer, small bowel, ureter, or renal pelvis). One is a first-degree relative of the other two. At least 2 successive generations affected. One cancer diagnosed before age 50.

    C. Tumor studies (MSI, IHC) are suggestive for Lynch Syndrome.

    D. Female family members who are at 25% or 50% risk for a lynch syndrome mutation may also be enrolled in the registry. 25% risk is defined as women with second degree family member grandmother, aunt, uncle, niece, and grandchild. 50% risk is defined as women with first degree family member being parent, child, sibling.

  2. Subjects must be 18 or older and able to give informed consent.

Exclusion Criteria:

1) None

  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: NCT00508573

Contacts
Contact: Karen H. Lu, MD 713-745-8902

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Karen H. Lu, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Karen H. Lu, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00508573     History of Changes
Other Study ID Numbers: 2006-0973
Study First Received: July 26, 2007
Last Updated: May 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Hereditary Nonpolyposis Colorectal Cancer
Lynch Syndrome
HNPCC
Syndrome Registry
Questionnaire
Endometrial cancer
Ovarian cancer

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

ClinicalTrials.gov processed this record on August 28, 2014