MDACC Study Summary ID01-340

Study Summary
No. ID01-340:.............Karen H. Lu......Gynecologic Oncology

Study Summary Title



Study Summary Number:	ID01-340

Study Title:	Modulation of Putative Surrogate Endpoint Biomarkers in Endometrial Biopsies from Women with HNPCC

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:		Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Three to four months after initiating hormone treatment, the patient will return for the post-treatment transvaginal ultrasound and endometrial biopsy.

Treatment Agents:		Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to look at the bio-markers in the endometrial lining of women with a high chance of getting hereditary non-polyposis colorectal cancer (HNPCC). Researchers eventually want to find out if the oral contraceptive LoOvral and the injectable contraceptive depomedroxyprogesterone (depoMPA) can help to decrease the risk of endometrial cancer.

Study Objectives / Outcomes

1. The primary objective is to evaluate the effect of progesterone therapy versus combination estrogen and progesterone therapy on potential surrogate endpoint biomarkers (SEBs) relevant to endometrial carcinogenesis.
2. To evaluate changes in histology and ultrasound appearance of the endometrium in women with HNPCC after 3 months of progesterone therapy versus combination estrogen and progesterone therapy compared with baseline.
3. To establish a point estimate of the baseline frequency of endometrial abnormalities looking at histological and molecular markers in a cohort of females carrying an HNPCC gene mutation.

Study Status Information



Study Activation / Registration Date:	02/12/2002

IRB Review and Approval Date:	07/18/2001

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	52 evaluable patients

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:

Unavailable

Exclusion Criteria:

Unavailable

Links

Registration Number: NCT00033358
Study Information on Clinical Trials Registry (clinicaltrials.gov)