MDACC Study Summary GYN01-142

Study Summary
No. GYN01-142:.......Breast; Ovary; Peritoneum......Karen H. Lu......Gynecologic Oncology

Study Summary Title



Study Summary Number:	GYN01-142

Study Title:	Ovarian Cancer Screening Pilot Trial in High 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:	713-745-8902 Contact us about clinical trials

General Information



Disease Group:	Breast Ovary Peritoneum	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	every 6 months

Treatment Agents:	Screening	Home Care:	n/a

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	The goal of this study is to learn if CA125 is helpful or not in the early detection of ovarian cancer among women at higher risk for this disease. Leftover blood samples will be frozen and stored for future research to find other biomarkers for ovarian cancer and other cancers.

Study Objectives / Outcomes

1. To determine the feasibility of prospective screening studies of high risk subjects within the CGN network and other NCI ovarian programs, and to identify the logistical issues of screening and their solutions within this framework.

2. To establish normal ranges and distributions for CA125 values over time in women at high risk of ovarian cancer with sub-classification by pre/post-menopausal status, ERT usage (yes/no), and prophylactic oophorectomy (yes/no). Such estimates would provide the basis for refining the risk of ovarian cancer algorithm (ROCA) more accurately to high-risk women and to providing guidance for clinical interpretation of CA125 tests in all such sub-groups.

3. To obtain estimates of the specificity and positive predictive value of ROCA suitable for designing a definitive trial of screening for ovarian cancer in high risk women.

4. To establish a longitudinal serum and plasma bio-repository for retrospective evaluation of other promising biomarkers with special relevance to inherited ovarian and breast cancer risk.

Study Status Information



Study Activation / Registration Date:	05/09/2001

IRB Review and Approval Date:	05/02/2001

Study Type:	Screening

Recruitment Status:	Open

Projected Accrual:	4200

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) The family of the subject has a BRCA1 or BRCA2 mutation – either: �The subject has tested positive for a BRCA1 or BRCA2 mutation; �the subject has a first or second degree relative with a BRCA1 or BRCA2 mutation OR

2) The family contains at least two ovarian or breast cancers among the subject and first and second degree relatives of the subject within the same lineage. This condition is satisfied by multiple primary cancers in the same person. Where breast cancer is required to meet this criterion, at least one breast cancer must be pre-menopausal (age at diagnosis less than or equal to 50 if age at menopause unknown). OR

3) The subject is of Ashkenazi Jewish ethnicity with one first degree or two second-degree relatives with breast or ovarian cancer, or subject is of Ashkenazi ancestry and has had breast cancer. Where breast cancer is required to meet this criterion, at least one breast cancer must be pre-menopausal (age at diagnosis less than or equal to 50 if age at menopause unknown). OR

4) Probability of carrying a BRCA1/2 mutation given family pedigree of breast and ovarian cancers as calculated by BRCAPRO exceeds 20%.

5) Signed informed consent.

Exclusion Criteria:

1) The subject is/has/has had: Ovarian cancer, including low malignant potential cancers (LMP), or primary papillary serous carcinoma of the peritoneum.

2) A first or second degree relative with a BRCA1/2 mutation and has tested negative for exactly the same mutation.

3) Less than 30 years of age

4) The subject has had both ovaries removed.

5) Currently pregnant or anticipating pregnancy during the study.

6) Participating in other ovarian cancer early detection trials.

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

8) Current untreated malignancy (other than non-melanoma skin cancer).

9) Adjuvant chemotherapy or radiation therapy for cancer within the past 3 months. (Women may be taking adjuvant hormonal therapies e.g. tamoxifen, lupron, zoladex, at enrollment and for study duration.)

10) Treatment (excluding hormonal therapies) for prior metastatic malignancy within the past five years.

11) Intraperitoneal surgery within the last 3 months (laparoscopy or laparotomy).

12) Patient has a history of any medical conditions that would place the patient at risk as a result of the blood donation. Such conditions include but are not limited to hemophilia or other bleeding disorders, chronic infectious disease, emphysema or serious anemia.

13) Optional Addition to Exclusion Criteria: Is not a BRCA1 or BRCA2 mutation carrier & has a risk of developing ov ca in the next 5 years lower than 0.25%. Sites with limited funding that wish to continue screening subjects past Jan 2007 may limit their screening to subjects at the very highest risk as identified by the BOADICEA program. BOADICEA was developed in the UK to estimate the risk of developing ov ca over the next 5 or other # of years given the family pedigree of ovarian & breast cancers, & any BRCA1 or BRCA2 mutation testing results available from family members including the proband.

Links

Registration Number: NCT00301743
Study Information on Clinical Trials Registry (clinicaltrials.gov)