Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

CA-125 in Screening Patients at High Risk for Ovarian Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Screening Closed 30 and over NCI UAB-120 UAB-0120, NCT00080639

Special Category: SPORE trial

Objectives

Primary

1. Determine the feasibility of prospective screening for ovarian cancer in high-risk patients.
2. Determine normal ranges and distributions of CA 125 within and between these patients (with subclassification by menopausal status, estrogen replacement therapy usage, and prophylactic oophorectomy).

Secondary

1. Determine estimates of the specificity and positive predictive value of a risk of cancer algorithm suitable for designing a definitive trial of screening for ovarian cancer in these patients.

Entry Criteria

Disease Characteristics:

• At high risk for developing ovarian cancer, as determined by meeting criteria for 1 of the following:
  • Family history of at least 2 ovarian or breast* cancers among the patient and first- and second-degree relatives within the same lineage**
    • If breast cancer* is required to meet this criterion, at least 1 breast cancer* must be premenopausal (diagnosed at age 50 or under if menopausal status unknown)

     [Note: **Multiple primary cancers in the same person satisfies this criterion]

  • Ashkenazi Jewish ethnicity and meets criteria for 1 of the following:
    • Prior breast cancer* diagnosis
    • One first-degree or 2 second-degree relatives with breast* or ovarian cancer
      • If breast cancer is required to meet this criterion, at least 1 breast cancer* must be premenopausal (diagnosed at age 50 or under if menopausal status unknown)
  • Probability of BRCA1 or BRCA2 mutation greater than 20%, as determined by BRCAPRO 95% posterior probability interval
    • This criterion includes the following situations for which BRCAPRO is not required:
      • Tested positive for a BRCA1 or BRCA2 mutation (100% probability)
      • First- or second-degree relative with a BRCA1 or BRCA2 mutation

   [Note: *Including ductal carcinoma in situ]




• No ovarian cancer, including low malignant potential cancers or primary papillary serous carcinoma of the peritoneum

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• More than 3 months since prior adjuvant chemotherapy for cancer

Endocrine therapy

• Concurrent adjuvant hormonal therapy (e.g., tamoxifen, leuprolide, or goserelin) allowed

Radiotherapy

• More than 3 months since prior adjuvant radiotherapy for cancer

Surgery

• More than 3 months since prior intraperitoneal surgery (laparoscopy or laparotomy)
• Prior prophylactic oophorectomy allowed

Other

• More than 5 years since prior treatment (excluding hormonal therapy) for metastatic malignancy
• No concurrent participation in other ovarian cancer early detection trials

Patient Characteristics:

Age

• 30 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• No hemophilia
• No other bleeding disorders

Hepatic

• Not specified

Renal

• Not specified

Pulmonary

• No emphysema

Other

• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception
• No psychiatric or psychological condition that would preclude giving informed consent
• No concurrent untreated malignancy except nonmelanoma skin cancer
• No other medical condition that would preclude blood draws (e.g., chronic infectious disease)

Expected Enrollment

A total of 2,400 patients will be accrued for this study within 1 year.

Outline

This is a multicenter, pilot study.

Patients undergo blood collection and CA 125 levels are measured at baseline and then every 3 months for 1-2 years. Patients may be referred for an ovarian ultrasound if indicated by the CA 125 results.

Patients are followed at 6 months and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

Edward Partridge, MD, Principal investigator		Ph: 205-934-4986 Email: parkers@uabmc.edu

Registry Information
Official Title		Specialized Program Of Research Excellence (SPORE) In Ovarian Cancer/Cancer Genetics Network Collaborative Ovarian Cancer Screening Pilot Trial In High Risk Women
Trial Start Date		2003-06-06
Registered in ClinicalTrials.gov		NCT00080639
Date Submitted to PDQ		2003-11-14
Information Last Verified		2005-05-03
NCI Grant/Contract Number		P50-CA83591, P30-CA72720

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