MDACC Study Summary ID01-022

Study Summary
No. ID01-022:.......Other Studies......Karen H. Lu......Gynecologic Oncology

Study Summary Title



Study Summary Number:	ID01-022

Study Title:	Use of the CA 125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk Women

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:	713-563-4579 Contact us about clinical trials

General Information



Disease Group:	Other Studies	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Return visits depend on the results of each woman's algorithm. See full protocol for details

Treatment Agents:	None	Home Care:	none

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	None


Description/ Intervention:	The goal of this clinical research study is to evaluate a method involving a blood test, called CA-125, that may be helpful in the early detection of ovarian cancer in post-menopausal women.

Study Objectives / Outcomes

1. To evaluate the longitudinal CA-125 algorithm for the early detection of ovarian cancer in a low risk cohort of women . The CA 125 algorithm, which calculates a woman's risk of having ovarian cancer based on age, CA-125 level and CA-125 levels over time, will be used to estimate a woman's risk of ovarian cancer. Based on this estimate, women in this study will be triaged after each new CA 125 measurement to: a) repeat the CA 125 in one year, b) repeat the CA 125 in three months, or c) undergo transvaginal sonography and repeat CA 125. Per principal investorgator's review of results, participants will return in three months or be referred to a gynecologic oncologist or qualified healthcare professional for follow-up care. In a single arm trial, we will test the hypothesis that the use of the algorithm can estimate the risk of ovarian cancer with a specificity of 98% and that the addition of transvaginal sonography further improves specificity.
2. To assess feasibility of population screening for ovarian cancer using the CA 125 algorithm in a low risk population.
3. To establish a serum bank that will allow more rapid assessment of specificity for novel markers and/or combinations of multiple markers for the early detection of ovarian cancer. Concurrent studies in the Ovarian SPORE include the discovery of novel markers for ovarian cancer and the development of other screening algorithms incorporating multiple markers. Establishment of the prospective tumor bank will allow more rapid assessment of specificity for these potential screening tools.
4. To measure peptides in the urine that could serve as biomarkers to detect early stage ovarian cancer. On going laboratory work suggests that urine analysis may be a reasonable non-invasive screening method.

Study Status Information



Study Activation / Registration Date:	07/02/2001

IRB Review and Approval Date:	02/21/2001

Study Type:	Therapeutic

Recruitment Status:	Open

Projected Accrual:	30,000 women years (total from all 6 sites: M. D. Anderson Cancer Center, Houston, Texas; The John Stoddard Cancer Center, Des Moines, Iowa; Women's and Infant's Hospital in Providence, Rhode Island, Obstetrics and Gynecology Associates (OGA), Houston, Texas, UT Southwestern, Dallas, Texas and Carol G. Simon Cancer Center , Morristown, New Jersey

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) Female, >/= 50 years old or less than 75 years old

2) Postmenopausal (>/= 12 months amenorrhea)

3) Have at least one ovary

4) Cancer-free and have not received any chemotherapy or radiation therapy for >/=12 months prior to enrolling on this study

5) Willingness to return to UTMD Anderson Cancer Center (UTMDACC)for CA 125 blood tests annually or earlier if indicated

6) 6) Willingness to return to UTMDACC to undergo transvaginal ultrasound if indicated.

7) Women need to provide the name of a gynecologist or qualified healthcare professional willing to provide appropriate follow-up care if indicated

Exclusion Criteria:

1) Female: Less than 50 years old or older than 75 years

2) Psychiatric or psychological or other conditions which prevent a fully informed consent.

3) Prior removal of both ovaries.

4) Active non-ovarian malignancy.

5) Women who have a history of non-ovarian malignancy will be eligible if they have no persistent or recurrent disease and have not received treatment for >12 months. If they are on SERM (i.e. tamoxifen or aromatase inhibitors) they will not be excluded. Women maybe undergoing or have had treatment <12 months prior to study entry for basal cell carcinoma only.

6) High risk for ovarian cancer : a. known mutation in BRCA1 of BRCA2.

7) Two 1st or 2nd degree relatives of same lineage who have: two ovarian cancers; one ovarian cancer and one pre-menopausal breast cancer; two pre-menopausal breast cancers; one pre-menopausal and one post menopausal breast cancer. These conditions can also be met using the participant and one 1st or 2nd degree female relative.

8) Askenazi Jewish descent with one 1st degree or two 2nd degree relatives with pre-menopausal breast or ovarian cancer or participant has had pre-menopausal breast cancer.

9) 1st or 2nd degree male relative with breast cancer diagnosed at any age. First degree relative defined as: children, siblings and parents. Second degree relative defined as half-siblings, aunts, uncles, nieces, nephews, grandparents, and grandchildren.

10) HNPCC/Lynch Syndrome: known genetic mutation, presumed HNPCC carrier, Amsterdam criteria.

Links

Registration Number: NCT00539162
Study Information on Clinical Trials Registry (clinicaltrials.gov)