MDACC Study Summary 2006-0973

Study Summary
No. 2006-0973:.......Endometrial......Karen H. Lu......Gynecologic Oncology

Study Summary Title



Study Summary Number:	2006-0973

Study Title:	Registry for Women Who Are At Risk Or May Have Lynch Syndrome

Physician

New Patient Referral



Name:	Karen H. Lu	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Gynecologic Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-8902 Contact us about clinical trials

General Information



Disease Group:	Endometrial	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	For initial visit

Treatment Agents:	Questionnaire	Home Care:	None

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	None required


Description/ Intervention:	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.

Study Objectives / Outcomes

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.

Study Status Information



Study Activation / Registration Date:	05/14/2007

IRB Review and Approval Date:	05/14/2007

Study Type:	Observational

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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. Familly 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.

2) 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 ramily member being parent, child, sibling.

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

Exclusion Criteria:

1) None

Links

Registration Number: NCT00508573
Study Information on Clinical Trials Registry (clinicaltrials.gov)