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NCT00539162
Use of the CA 125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk Women
NA trial testing Questionnaire in Ovarian Cancer in 8,000 participants. Currently enrolling.
30 November 2028
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 8,000 |
| Start date | 2 July 2001 |
| Primary completion | 30 November 2028 |
| Estimated completion | 30 November 2028 |
| Sites | 11 locations across United States |
Drugs / interventions tested
- Questionnaire
Conditions studied
- Ovarian Cancer — all drugs for Ovarian Cancer →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
Adults 50 to 74, female only, with Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical research study is to evaluate a method involving 4 blood tests called CA-125, HE4, HE4 antigen autoantibody complexes, and osteopontin that may be helpful in the early detection of ovarian cancer in women who are at low risk.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
A 2-stage ovarian cancer screening strategy using the Risk of Ovarian Cancer Algorithm (ROCA) identifies early-stage incident cancers and demonstrates high positive predictive value.
Lu KH, Skates S, Hernandez MA, Bedi D, et al · · 2013 · cited 90× · PMID 23983047 · DOI 10.1002/cncr.28183 -
Early detection biomarkers for ovarian cancer.
Sarojini S, Tamir A, Lim H, Li S, et al · · 2012 · cited 64× · PMID 23319948 · DOI 10.1155/2012/709049 -
Epigenetic Biomarkers in the Management of Ovarian Cancer: Current Prospectives.
Singh A, Gupta S, Sachan M. · · 2019 · cited 50× · PMID 31608277 · DOI 10.3389/fcell.2019.00182 -
Normal Risk Ovarian Screening Study: 21-Year Update.
Han CY, Lu KH, Corrigan G, Perez A, et al · · 2024 · cited 12× · PMID 38194613 · DOI 10.1200/jco.23.00141 -
Autoantibodies, antigen-autoantibody complexes and antigens complement CA125 for early detection of ovarian cancer.
Young Han C, Bedia JS, Yang WL, Hawley SJ, et al · · 2024 · cited 10× · PMID 38195887 · DOI 10.1038/s41416-023-02560-z -
Validation of machine learning-based models to predict and explain the risk of ovarian cancer: a multicentric study on <i>BRCA</i>-mutated patients undergoing risk-reducing salpingo-oophorectomy.
Loizzi V, Comes MC, Arezzo F, Apostol AI, et al · · 2025 · PMID 40303993 · DOI 10.3389/fonc.2025.1574037
Verify or expand the search:
- PubMed search for NCT00539162
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00539162 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 16 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00539162.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing