Ovarian CancerNCT06118307
Shanghai Ovarian Cancer and Family Care Project
An observational study of Ovarian Cancer, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer
- How many people
- 3,546 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2013to 13 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai first maternity and infant hospital
Shanghai, Shanghai Municipality, 200120
Zhen Li, PhD, 20261385 ext. 86, zhen_li@tongji.edu.cn
About this study
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.
- Conditions
- Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death due to ovarian cancer
Death due to ovarian cancer determined by independent outcomes committee.
Measured: From diagnosis of ovarian cancer until October 31, 2028.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Jan 2013
- Primary completion13 Oct 2028 (estimated)
- Study completion13 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 3,546 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118307
- Sponsor's protocol ID
- KS23259
- Status last verified
- Oct 2023
- First submitted
- 31 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40012035
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Ovarian Cancer and Family Care Project
- ClinicalTrials.gov ID
- NCT06118307
- Acronym / sponsor ID
- KS23259
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,546 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 13 Oct 2028 (estimated)
- Study completion
- 13 Oct 2028 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death due to ovarian cancer
Time frame: From diagnosis of ovarian cancer until October 31, 2028.
Death due to ovarian cancer determined by independent outcomes committee.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Derived from this study: PubMed 40012035Shi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Wang, MD; PhD (20261208 ext. 86, renjiwangyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death due to ovarian cancer (time frame: From diagnosis of ovarian cancer until October 31, 2028.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06118307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.