Epithelial Ovarian CancerNCT06366997
Diagnosis of Epithelial Ovarian Cancer Using Ovarian Cancer Score (OCS) Test
An observational study of Epithelial Ovarian Cancer and Adnexal Mass, run by Chongqing University Cancer Hospital at 1 site in China.
Trial summary
The study is designed to confirm the performance of the 3D Medicines Corporation OCS test in diagnosis of epithelial ovarian cancer in patients with adnexal mass. To this end, blood samples from female patients with adnexal mass required surgical resection from four centers are obtained and analysis in the study. 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
- Epithelial Ovarian Cancer, Adnexal Mass
- How many people
- 1,352 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2019to 5 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adnexal masses (i.e., lumps near the uterus or in or around the ovaries, fallopian tubes, or surrounding connecting tissues) are common and are often detected by primary care providers and gynecologists. Adnexal masses are seen in up to 35% of premenopausal women and 17% of postmenopausal women and can occur throughout a woman's life. Although the majority of these masses are benign, they must be evaluated to rule out the possibility of malignant ovarian cancer. Ovarian cancer is one of the most aggressive gynecologic tumors worldwide, with over 31,4000 new cases diagnosed and 21,3000 deaths each year1,2. Ovarian cancer is the most lethal gynecologic malignancy with an overall 5-year survival rate of 45%.
Who may be able to join
- a) ≥ 18 years of age;
- b) Patients with adnexal masses;
- c) Sign the informed consent form;
- d) Adnexal mass that requires excision;
Who cannot join
- a) history of chemoradiotherapy;
- b) history of malignancy;
- c) pregnancy;
- d) Adnexal mass not require surgical excision;
- e) The adnexal mass has been diagnosed as malignant before surgery, and the number of cases enrolled in a single institution exceeds 50;
- f) Blood CA125 value greater than 1000 U/ml at initial treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
No.181, Hanyulu Road, Shapingba District
Chongqing, Chongqing Municipality, 400030
About this study
Official title: Multicenter Clinical Research for Diagnosis of Epithelial Ovarian Cancer Using OCS Test
The study is designed to confirm the performance of the 3D Medicines Corporation OCS test in diagnosis of epithelial ovarian cancer in patients with adnexal mass. To this end, blood samples from female patients with adnexal mass required surgical resection from four centers are obtained and analysis in the study.
- Conditions
- Epithelial Ovarian Cancer, Adnexal Mass
- Keywords
- early diagnosis, ovarian cancer, OCS test
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Disease, Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
the Performance of Discrimination of Benign Disease and Malignant tumors by the OCS Value.
Evaluation of the performance of the OCS value in discriminating between benign and malignant tumors. Serum was collected before surgery. The serum OCS value was calculated with the serum level of extracellular vesicle biomarkers using a preset formula. The unit for each EV biomarker in the formula was as follows: Carbohydrate antigen 125 (CA125, U/ml), Human Epididymis Protein (HE4, pmol/L) and Complement Component 5a (5a, ng/ml). The OCS value was a numerical value witout units. The OCS value above the preset cut-off (0.506) value indicated maligant tumor, otherwise the adnexal mass was benign. The concordance between the pathological results (gold standard) and the results predicted by the OCS value was compared.
Measured: Data analysis would be completed in three months after all data were collected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start9 Oct 2019
- Primary completion18 Apr 2023
- Study completion5 May 2023
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 Epithelial 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
- Prospective
- Enrolment
- 1,352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing University Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital of Zhengzhou University, 3D Medicines Corporation
- Responsible party
- Sponsor
- Investigators
- Qi Zhou, Principal investigator, Chongqing University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366997
- Sponsor's protocol ID
- CQGOG0207
- Status last verified
- Apr 2024
- First submitted
- 13 Mar 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang H, Zhu J, Zou D, Rao Q, Han L, Lu H, Wang J, Liu L, Ma L, Sun L, Yi L, Feng W, Zhang Y, Du Y, Yang M, Feng Y, Zhang D, Lin Z, Zhou Q. Multicenter study of ovarian cancer score for diagnosing ovarian cancer. Gynecol Oncol. 2025 Feb;193:58-64. doi: 10.1016/j.ygyno.2024.12.017. Epub 2025 Jan 9.
PubMed 39793443
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Clinical Research for Diagnosis of Epithelial Ovarian Cancer Using OCS Test
- ClinicalTrials.gov ID
- NCT06366997
- Acronym / sponsor ID
- CQGOG0207
- Conditions
- Epithelial Ovarian Cancer, Adnexal Mass
- Keywords
- early diagnosis, ovarian cancer, OCS test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,352 participants (actual)
- Lead sponsor
- Chongqing University Cancer HospitalUniversity, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital of Zhengzhou University, 3D Medicines Corporation
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 16 Apr 2024 (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.
The study is designed to confirm the performance of the 3D Medicines Corporation OCS test in diagnosis of epithelial ovarian cancer in patients with adnexal mass. To this end, blood samples from female patients with adnexal mass required surgical resection from four centers are obtained and analysis in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adnexal masses (i.e., lumps near the uterus or in or around the ovaries, fallopian tubes, or surrounding connecting tissues) are common and are often detected by primary care providers and gynecologists. Adnexal masses are seen in up to 35% of premenopausal women and 17% of postmenopausal women and can occur throughout a woman's life. Although the majority of these masses are benign, they must be evaluated to rule out the possibility of malignant ovarian cancer. Ovarian cancer is one of the most aggressive gynecologic tumors worldwide, with over 31,4000 new cases diagnosed and 21,3000 deaths each year1,2. Ovarian cancer is the most lethal gynecologic malignancy with an overall 5-year survival rate of 45%.
Key inclusion criteria (4 listed)
- a) ≥ 18 years of age;
- b) Patients with adnexal masses;
- c) Sign the informed consent form;
- d) Adnexal mass that requires excision;
Key exclusion criteria (6 listed)
- a) history of chemoradiotherapy;
- b) history of malignancy;
- c) pregnancy;
- d) Adnexal mass not require surgical excision;
- e) The adnexal mass has been diagnosed as malignant before surgery, and the number of cases enrolled in a single institution exceeds 50;
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
the Performance of Discrimination of Benign Disease and Malignant tumors by the OCS Value.
Time frame: Data analysis would be completed in three months after all data were collected.
Evaluation of the performance of the OCS value in discriminating between benign and malignant tumors. Serum was collected before surgery. The serum OCS value was calculated with the serum level of extracellular vesicle biomarkers using a preset formula. The unit for each EV biomarker in the formula was as follows: Carbohydrate antigen 125 (CA125, U/ml), Human Epididymis Protein (HE4, pmol/L) and Complement Component 5a (5a, ng/ml). The OCS value was a numerical value witout units. The OCS value above the preset cut-off (0.506) value indicated maligant tumor, otherwise the adnexal mass was benign. The concordance between the pathological results (gold standard) and the results predicted by the OCS value was compared.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Derived from this study: PubMed 39793443Wang H, Zhu J, Zou D, Rao Q, Han L, Lu H, Wang J, Liu L, Ma L, Sun L, Yi L, Feng W, Zhang Y, Du Y, Yang M, Feng Y, Zhang D, Lin Z, Zhou Q. Multicenter study of ovarian cancer score for diagnosing ovarian cancer. Gynecol Oncol. 2025 Feb;193:58-64. doi: 10.1016/j.ygyno.2024.12.017. Epub 2025 Jan 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. This study is not recruiting at the moment.
Qi Zhou principal investigator
Chongqing University Cancer Hospital
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 Epithelial Ovarian Cancer and Adnexal Mass, run by Chongqing University Cancer 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 16 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Performance of Discrimination of Benign Disease and Malignant tumors by the OCS Value. (time frame: Data analysis would be completed in three months after all data were collected.). 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 NCT06366997, 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 16 Apr 2024.