Clinical trial · Observational
CA-125 in Screening Patients at High Risk for Ovarian Cancer
Specialized Program Of Research Excellence (SPORE) In Ovarian Cancer/Cancer Genetics Network Collaborative Ovarian Cancer Screening Pilot Trial In High Risk Women
NCT00080639CI-TRIAL-00011597withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated for administrative reasons and becuase there were no enrollments
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| physiologic testing | Other | — | UNRESOLVED |
| study of high risk factors | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- 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 (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
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 trialsReferences
Publications (0)
Data not yet available
No reference posted for this study.