Shanghai Ovarian Cancer and Family Care Project

Sponsor
Shanghai First Maternity and Infant Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06118307
Collaborator
(none)
3,546
1
189.4
18.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3546 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Shanghai Ovarian Cancer and Family Care Project
    Actual Study Start Date :
    Jan 1, 2013
    Anticipated Primary Completion Date :
    Oct 13, 2028
    Anticipated Study Completion Date :
    Oct 13, 2028

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Death due to ovarian cancer [From diagnosis of ovarian cancer until October 31, 2028.]

      Death due to ovarian cancer determined by independent outcomes committee.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Participant meet the criteria for one of the following conditions:
    • Patients attending the oncology department require differential diagnosis of ovarian cancer.

    • Patients with known high-risk factors for ovarian cancer, such as history of ovarian cancer or BRCA-associated cancer, etc.

    • Patients attending the Physical Examination Center who have normal findings on physical examination and no symptoms.

    Exclusion Criteria:
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai first maternity and infant hospital Shanghai Shanghai China 200120

    Sponsors and Collaborators

    • Shanghai First Maternity and Infant Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai First Maternity and Infant Hospital
    ClinicalTrials.gov Identifier:
    NCT06118307
    Other Study ID Numbers:
    • KS23259
    First Posted:
    Nov 7, 2023
    Last Update Posted:
    Nov 7, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 7, 2023