Clinical trial NCT00080639: CA-125 in Screening Patients at High Risk for Ovarian Cancer
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 type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ovarian Cancer
Keywords: ovarian epithelial cancer
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-04-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women know to be at high risk for ovarian cancer

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.

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 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

Primary outcomes:
measure: Determine the feasibility of prospective screening for ovarian cancer in high-risk patients.
timeFrame: baseline
measure: 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).
timeFrame: baseline
Secondary outcomes:
measure: 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.
timeFrame: baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Comprehensive Cancer Center at University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Edward E. Partridge, MD
role: PRINCIPAL_INVESTIGATOR
References: