A multicenter study to evaluate the sensitivity and specificity of novel blood markers in the adjunctive diagnosis of ovarian cancer

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2000040136

Enrollment

Unknown

Registered

2020-11-22

Start date

2016-10-10

Completion date

Unknown

Last updated

2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ovarian cancer

Interventions

Gold Standard:Pathology examination

Index test:3D-EDX01&#32

versus&#32

CA125,&#32

HE4&#32

and&#32

CA125&#32

combined&#32

with&#32

HE4

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Informed consent; 2. Epithelial ovarian cancer was confirmed by surgical pathology; 3. Benign ovarian disease confirmed by surgical pathology

Exclusion criteria

Exclusion criteria: 1. A history of malignancy other than ovarian cancer, with the exception of basal cell carcinoma or cervical carcinoma in situ, and intramucosal gastric cancer that has been completely removed; 2. Had received any preoperative neoadjuvant therapy for ovarian cancer.

Design outcomes

Primary

Measure	Time frame
CA125;HE4;3D-EDX01;SEN, SPE, ACC, AUC of ROC;	—

Countries

China

Contacts

Public ContactYuanjing Hu

Tianjin Central Hospital Of Gynecology Obstetrics

tdjhyj@hotmail.com+86 18920196053

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 14, 2026