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CA-125 in Screening Patients at High Risk for Ovarian Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00080639
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Procedure: physiologic testing
Procedure: study of high risk factors
Phase II

MedlinePlus related topics: Cancer Ovarian Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Screening
Official Title: Specialized Program Of Research Excellence (SPORE) In Ovarian Cancer/Cancer Genetics Network Collaborative Ovarian Cancer Screening Pilot Trial In High Risk Women

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2003
Detailed 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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00080639

Locations
United States, Alabama
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
Sponsors and Collaborators
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
Investigators
Principal Investigator: Edward E. Partridge, MD Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000353332, UAB-120, UAB-0120
Study First Received: April 7, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00080639  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
ovarian epithelial cancer

Study placed in the following topic categories:
Genital Diseases, Female
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Ovarian epithelial cancer
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009