Clinical trial · Interventional
Cancer Screening Program for Women at High Risk for Developing Ovarian Cancer
Ovarian Cancer Early Detection Screening Program
NCT01292733CI-TRIAL-00020576OCEDPterminatedEarly Phase 1ClinicalTrials.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): Closed per local IRB due to advancements in standard ovarian cancer screening.
Summary
Brief summary (as posted)
The main purpose of this program is to see whether periodically measuring CA-125 (tumor marker) levels in the blood and undergoing transvaginal ultrasounds over time will be effective in the early detection of ovarian cancer.
Conditions
Conditions (2)
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 Diseases | — | UNRESOLVED | — |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Health Status Questionnaire | Other | — | UNRESOLVED |
| Laboratory Tumor Marker Analysis | Other | — | UNRESOLVED |
| Transvaginal Ultrasound | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ovarian Cancer Screening
- description
- CA125 tumor marker, Transvaginal Ultrasound, Health Status Questionnaires
- interventionNames
- Other: Laboratory Tumor Marker Analysis
- Other: Transvaginal Ultrasound
- Other: Health Status Questionnaire
Primary outcomes (1)
- measure
- Measuring for elevated levels of tumor marker CA-125 in the blood over time.
- timeFrame
- Average expected time of 1 year
Secondary outcomes (2)
- measure
- Performing transvaginal ultrasounds to look for any abnormalities over time.
- timeFrame
- Average expected time of 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Must meet one of the following: * The family contains at least two ovarian or breast cancers in the subject or first or second degree relatives of the subject. * The subject is of Ashkenazi Jewish ethnicity with one first degree or two second-degree relatives with breast or ovarian cancer, or subject is of Ashkenazi ancestry and has had breast cancer. * The subject has a male relative with breast cancer diagnosed at any age. * Probability of carrying a BRCA1/2 mutation given family pedigree of breast and ovarian cancers exceeds 20% (as determined by BRCAPRO 95% posterior probability interval). Exclusion Criteria: * Prior ovarian cancer or peritoneal carcinomatosis * A first or second degree relative with a BRCA1/2 mutation and has tested negative for exactly the same mutation. * The subject has no ovaries. * Less than 30 years of age, unless 25-30 with BRCA I or II mutation confirmed * Currently pregnant * Currently receiving adjuvant chemotherapy or radiation therapy for cancer (excluding tamoxifen). Patients who are being treated for local disease may enroll 3 months after completion of last treatment (excluding tamoxifen). * Treatment (excluding tamoxifen) for prior metastatic malignancy within the past five years. * Intraperitoneal surgery within the last 3 months.
References
Publications (0)
Data not yet available
No reference posted for this study.