Last reviewed · How we verify
NCT05801263
ctDNA Methylation for Epithelial Ovarian Cancer
trial testing CDO1 and HOXA9 methylation assay in Epithelial Ovarian Cancer in 5,000 participants. Status unknown.
24 March 2024
Quick facts
| Lead sponsor | Lei Li |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 5,000 |
| Start date | 24 March 2023 |
| Primary completion | 24 March 2024 |
| Estimated completion | 24 March 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- CDO1 and HOXA9 methylation assay
Conditions studied
- Epithelial Ovarian Cancer — all drugs for Epithelial Ovarian Cancer →
- Circulating Tumor DNA — all drugs for Circulating Tumor DNA →
- DNA Methylation — all drugs for DNA Methylation →
- Non-invasive Diagnosis — all drugs for Non-invasive Diagnosis →
Sponsor
Lei Li — full company profile →
Who can join
18 and older, female only, with Epithelial Ovarian Cancer or Circulating Tumor DNA. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Ovarian cancer is one of the most dangerous and predominant gynecological cancers, with a high cancer-related mortality rate in women. However, current testing methods are still limited, and if detected early, patients have a five-year survival rate of 92%. Therefore, early diagnosis and detection are crucial for diagnosing and treating ovarian cancer. According to the results of the researchers' previous research, it has been found that CDO1 and HOXA9 genes are hypermethylated in ovarian cancer, and the expression of free DNA methylation in plasma can be used as one of the biomarkers for detection. In a single-center retrospective/prospective study, it has been demonstrated that the detection of CDO1 and HOXA9 methylation levels based on cell-free DNA in blood and comparison with ovarian pathology results can achieve \>80% sensitivity and specificity. To further explore the application of methylation detection technology in ovarian cancer, the application value of non-invasive diagnosis and prognosis follow-up will be explored to clarify the clinical application value of DNA methylation for early detection of ovarian cancer in the real world. The investigators will conduct a prospective multi-center cohort study, referred to as the OVAMethy study, which will involve more than ten research centers and is expected to recruit more than 5,000 clinical subjects to test the methylation detection kit and histopathology further, ROMA index and imaging results, and sensitivity and specificity technical performance parameters.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Circulating tumor DNA methylation detection as biomarker and its application in tumor liquid biopsy: advances and challenges.
Li L, Sun Y. · · 2024 · cited 52× · PMID 39525954 · DOI 10.1002/mco2.766
Verify or expand the search:
- PubMed search for NCT05801263
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Epithelial Ovarian Cancer
Currently open trials in the same condition.
- NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
- NCT07480954 — Dual-Targeting CAR-NK Cells for Recurrent Ovarian Cancer (MSLN, FRα, MUC16) · Phase 1, PHASE2 · recruiting
- NCT07218809 — AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Can · Phase 3 · recruiting
- NCT07495397 — Single-arm, Prospective Clinical Trial of Efficacy and Safety of Daphnetin Capsules Combined With TC Regimen for Targete · NA · recruiting
- NCT06915025 — Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemo · Phase 3 · recruiting
Other Lei Li trials
Trials by the same sponsor.
- NCT06558019 — Exosome-based OCS Scores for Predicting Ovarian Cancer Recurrence · not yet recruiting
- NCT06557954 — Cervical Cytology DNA Methylation for Cervical Cancer Screening · not yet recruiting
- NCT05801276 — ctDNA Methylation for Detecting Ovarian Cancer · unknown
- NCT06490380 — HRD Status Reference Standard Based on WGS · completed
- NCT05311579 — Niraparib Plus Anlotinib for Recurrent Ovarian Cancer · Phase 2 · unknown
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 NCT05801263 (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 Lei Li
- Last refreshed: 6 April 2023
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/NCT05801263.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing