NCT06118307

Brief Summary

Ovarian cancer is the most lethal gynaecological malignancy, but its incidence in the general population is low. Due to the lack of effective prevention and successful screening approaches, most cases are diagnosed at advanced stages, leading to poor prognosis. In order to address the research requirements pertaining to ovarian cancer, the Shanghai Ovarian Cancer and Family Care Project was established. This initiative offers hospital-based resources for investigating ovarian cancer and high-risk populations. The project comprises an on-going ovarian cancer cohort, a high-risk population cohort, and a healthy population cohort. By leveraging these comprehensive cohorts, the project provides a unique platform for in-depth studies on the detection, prevention, early diagnosis, treatment, and prognosis of ovarian cancer.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,546

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jan 2013Oct 2028

Study Start

First participant enrolled

January 1, 2013

Completed
10.8 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2028

Last Updated

November 7, 2023

Status Verified

October 1, 2023

Enrollment Period

15.8 years

First QC Date

October 31, 2023

Last Update Submit

October 31, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Death due to ovarian cancer

    Death due to ovarian cancer determined by independent outcomes committee.

    From diagnosis of ovarian cancer until October 31, 2028.

Study Arms (3)

Ambispective patient cohort

Patients attending the oncology department require differential diagnosis of ovarian cancer.

High-risk population cohort

Family members of ovarian cancer patients; family history of BRCA mutation-related disease; abnormal findings on ovarian cancer screening; history of ovarian disease and other risk factors.

Healthy control cohort

Healthy women with normal health examination results.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients attending the oncology department; patients with known risk factors for ovarian cancer; healthy individuals who are in good health determined by physical examination.

You may not qualify if:

  • Individuals with evidence of another active cancer.
  • Individuals who have prior bilateral oophorectomy.
  • Individuals who are unwilling or unable to sign the informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai first maternity and infant hospital

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

Related Publications (1)

  • Shi W, Zhang Y, Cheng S, Zhao Y, Li N, Li Y, Yang Y, Ding H, Li Z, Wang Y. Protocol of the SOCFC project: a longitudinal cohort study of ovarian cancer patients, high-risk populations, and healthy controls to identify factors and biomarkers associated with disease diagnosis and prognosis. BMC Cancer. 2025 Feb 26;25(1):355. doi: 10.1186/s12885-025-13652-9.

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Central Study Contacts

Yu Wang, MD; PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2023

First Posted

November 7, 2023

Study Start

January 1, 2013

Primary Completion (Estimated)

October 13, 2028

Study Completion (Estimated)

October 13, 2028

Last Updated

November 7, 2023

Record last verified: 2023-10

Locations