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CA-125 in Screening Patients at High Risk for Ovarian Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2005 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on April 7, 2004.   Last Updated on May 30, 2009   History of Changes
Sponsor: University of Alabama at Birmingham
Collaborator: 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
Other: physiologic testing
Procedure: study of high risk factors
Phase II

Study Type: Interventional
Study Design: Primary Purpose: 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

Resource links provided by NLM:


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
University of Alabama at Birmingham
Investigators
Principal Investigator: Edward E. Partridge, MD University of Alabama at Birmingham
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00080639     History of Changes
Other Study ID Numbers: CDR0000353332, UAB-120, UAB-0120
Study First Received: April 7, 2004
Last Updated: May 30, 2009
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on February 12, 2012