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

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ClinicalTrials.gov Identifier: NCT00080639
Recruitment Status : Withdrawn (Terminated for administrative reasons and becuase there were no enrollments)
First Posted : April 8, 2004
Last Update Posted : August 5, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Alabama at Birmingham

Study Description
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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.


Condition or disease Intervention/treatment
Ovarian Cancer Other: physiologic testing Procedure: study of high risk factors

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.

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Specialized Program Of Research Excellence (SPORE) In Ovarian Cancer/Cancer Genetics Network Collaborative Ovarian Cancer Screening Pilot Trial In High Risk Women
Study Start Date : June 2003
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Determine the feasibility of prospective screening for ovarian cancer in high-risk patients. [ Time Frame: baseline ]
  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). [ Time Frame: baseline ]

Secondary Outcome Measures :
  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. [ Time Frame: baseline ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women know to be at high risk for ovarian cancer
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00080639


Locations
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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
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Edward E. Partridge, MD University of Alabama at Birmingham
More Information
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Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00080639    
Other Study ID Numbers: CDR0000353332
UAB-120
UAB-0120
First Posted: April 8, 2004    Key Record Dates
Last Update Posted: August 5, 2013
Last Verified: August 2013
Keywords provided by University of Alabama at Birmingham:
ovarian epithelial cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
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