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

Ovarian Cancer Clinical Trial

Official title:

Specialized Program Of Research Excellence (SPORE) In Ovarian Cancer/Cancer Genetics Network Collaborative Ovarian Cancer Screening Pilot Trial In High Risk Women

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00080639
• Other study ID #: CDR0000353332
• Secondary ID: UAB-120UAB-0120
• Status: Withdrawn
• Phase: Phase 2
• First received: April 7, 2004
• Last updated: August 1, 2013
• Start date: June 2003
• Est. completion date: June 2007

Study information

• Verified date: August 2013
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

RATIONALE: Measuring levels of CA 125 in blood samples of women who have a high risk of developing ovarian cancer may help doctors detect cancer early and plan more effective treatment.

PURPOSE: This phase II trial is studying CA-125 levels in screening for cancer in women who are at high risk of developing ovarian cancer.

Description:

OBJECTIVES:

Primary

• Determine the feasibility of prospective screening for ovarian cancer in high-risk patients.

• 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

• 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.

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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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

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)

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Other:
• physiologic testing

Procedure:
• study of high risk factors

Locations

Country	Name	City	State
United States	Comprehensive Cancer Center at University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the feasibility of prospective screening for ovarian cancer in high-risk patients.		baseline	No
Primary	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).		baseline	No
Secondary	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.		baseline	No