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

NCT00080639 | Withdrawn DMC

• 3 other identifiers: CDR0000353332UAB-120UAB-0120
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer

Keywords

ovarian epithelial cancer

Outcome Measures

Primary Outcomes (2)

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

  baseline

• 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

Secondary Outcomes (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.

  baseline

Interventions

physiologic testing OTHER

study of high risk factors PROCEDURE

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women know to be at high risk for ovarian cancer

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Comprehensive Cancer Center at University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Edward E. Partridge, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2004
• First Posted: April 8, 2004
• Study Start: June 1, 2003
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: August 5, 2013

Record last verified: 2013-08

Locations

US (1)