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Establishment and application of clinical screening and chronic disease management system for hereditary ovarian cancer

Establishment and application of clinical screening and chronic disease management system for hereditary ovarian cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000037198
Enrollment
Unknown
Registered
2020-08-27
Start date
2021-01-30
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

hereditary ovarian cancer

Interventions

Gold Standard:Pathological diagnosis
Index test:TnCA125

Sponsors

Obstetrics & Gynecology Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
30 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Age: 30-60 years; 2) With hereditary ovarian cancer susceptibility gene harmful mutations: BRCA1, BRCA2, BRIP1, PALB2, RAD51C , RAD51D, BARD1, MSH2, MSH6, MLH1, PMS2, EPCAM; 3) Have at least one ovary or fallopian tube; 4) Able to follow the research protocol and follow up on schedule; 5) Signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Have a personal history of ovarian cancer, including low malignant potential cancers (LMP), or primary papillary serous carcinoma of the peritoneum; 2) Have received preventive salpingo-oophorectomy (RRSO); 3) Participating in other early screening tests for ovarian cancer; 4) have a history of any medical conditions that would place the subject at risk related to phlebotomy, including but not limited to hemophilia or other bleeding disorders, chronic infectious disease, emphysema or serious anemia.

Design outcomes

Primary

MeasureTime frame
sensitivity;specificity;positive predictive value;negative predictive value;

Countries

Cinia

Contacts

Public ContactKang Yu

Obstetrics & Gynecology Hospital of Fudan University

ykang@126.com+86 13636328211

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026