Ovarian CancerNCT07153705
OCS Products Based on Exosome Technology Were Applied in the Recurrence Monitoring Study After the Initial Treatment of Baseline CA125-negative Ovarian Cancer
An observational study of Ovarian Cancer, run by Beihua Kong.
Trial summary
To study the performance of OCS products based on exosome detection technology in monitoring the recurrence of baseline CA125-negative ovarian cancer patients after initial treatment, and to explore reliable methods for monitoring the recurrence of baseline CA125-negative ovarian cancer patients after initial… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Apr 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ovarian cancer
Who may be able to join
- Women over 18 years old;
- Pathologically confirmed as stage I-IV primary epithelial ovarian malignant tumor;
- ECOG < 2;
- The expected survival period exceeds 6 months;
- CA125 ≤ 35 U/ml before initial treatment;
- Undergo surgery and adjuvant chemotherapy;
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- The period between diagnosis and enrollment does not exceed 8 weeks;
- Be willing to provide blood samples for OCS testing during the research process;
- Sign the informed consent form.
Who cannot join
- Have had other malignant tumors within the last five years;
- Have received any treatment for ovarian cancer;
- Benign ovarian mass;
- Non-primary ovarian tumors;
- Combined with other malignant tumors;
- Patients receiving neoadjuvant therapy;
- Pregnancy.
About this study
To study the performance of OCS products based on exosome detection technology in monitoring the recurrence of baseline CA125-negative ovarian cancer patients after initial treatment, and to explore reliable methods for monitoring the recurrence of baseline CA125-negative ovarian cancer patients after initial treatment.
- Conditions
- Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
OCS product inspection
Measured: Before the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cross-sectional
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beihua Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Beihua Kong, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153705
- Sponsor's protocol ID
- CM-2401
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCS Products Based on Exosome Technology Were Applied in the Recurrence Monitoring Study After the Initial Treatment of Baseline CA125-negative Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07153705
- Acronym / sponsor ID
- CM-2401
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Beihua KongUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 4 Sep 2025 (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.
To study the performance of OCS products based on exosome detection technology in monitoring the recurrence of baseline CA125-negative ovarian cancer patients after initial treatment, and to explore reliable methods for monitoring the recurrence of baseline CA125-negative ovarian cancer patients after initial treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ovarian cancer
Key inclusion criteria (9 listed)
- Women over 18 years old;
- Pathologically confirmed as stage I-IV primary epithelial ovarian malignant tumor;
- ECOG < 2;
- The expected survival period exceeds 6 months;
- CA125 ≤ 35 U/ml before initial treatment;
Key exclusion criteria (7 listed)
- Have had other malignant tumors within the last five years;
- Have received any treatment for ovarian cancer;
- Benign ovarian mass;
- Non-primary ovarian tumors;
- Combined with other malignant tumors;
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
OCS product inspection
Time frame: Before the operation
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 4 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Beihua Kong.
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 9 inclusion and 7 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: opening soon, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
OCS product inspection (time frame: Before the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2025.