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NCT00539162

Use of the CA 125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk Women

Recruiting now NA Last updated 16 April 2026
What this trial tests

NA trial testing Questionnaire in Ovarian Cancer in 8,000 participants. Currently enrolling.

Timeline
2 July 2001
Primary endpoint
30 November 2028
30 November 2028

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposescreening
Enrollment8,000
Start date2 July 2001
Primary completion30 November 2028
Estimated completion30 November 2028
Sites11 locations across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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

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Data sources for this page

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