Ovarian CancerNCT06925126
Exosome-based Recurrence Score for Post-Treatment Ovarian Cancer
An observational study of Ovarian Cancer, run by Fudan University.
Trial summary
The goal of this observational study is to develop an exosome-based scoring model for post-treatment surveillance of recurrence in ovarian cancer. The main questions it aims to answer are: 1. Does this model have the potential for ovarian cancer recurrence monitoring? 2. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Not applicable- observational study
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 31 Dec 2027
- 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 recurrent epithelial ovarian cancer who treated in the Fudan University Shanghai Cancer Center
Who may be able to join
- Women aged ≥ 18 years
- Pathologic confirmed stage I-IV epithelial ovarian cancer, with ≤2 prior lines of therapy (maintenance therapy is not counted as a line of treatment), platinum-sensitive recurrence (achieved complete/partial response [CR/PR] after last platinum-based chemotherapy, with a platinum-free interval >6 months), and radiologically confirmed recurrent disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- A life expectancy of at least 6 months
- Written informed consent
Who cannot join
- Patients with non-epithelial tumors
- Patients with history of other malignancies within the past 5 years (except completely resected basal cell carcinoma or squamous cell carcinoma of the skin)
- Women who are pregnant, lactating, or intend to become pregnant during the study period
- Patients who refuse to participate in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Exosome-based Scoring Model for Post-treatment Surveillance of Recurrence in Ovarian Cancer
The goal of this observational study is to develop an exosome-based scoring model for post-treatment surveillance of recurrence in ovarian cancer. The main questions it aims to answer are:
- Does this model have the potential for ovarian cancer recurrence monitoring?
- Can this model demonstrate superior performance to CA125 for ovarian cancer recurrence monitoring?
Participants will :
- Provide serial blood samples at predefined times
- Undergo standardized imaging and clinical assessments during follow-up visits
Read the detailed description
Ovarian cancer is the most lethal gynecologic malignancy with the lowest survival rate among the three major gynecological malignancies. Over 70% of ovarian cancer patients experience recurrence within three years after initial treatment, making treatment response prediction and recurrence monitoring during treatment phases and follow-up visits particularly crucial. CA125 remains the primary recommended biomarker for ovarian cancer recurrence surveillance in current national and international guidelines, while its suboptimal performance necessitates further improvements.
Clinical trial data demonstrated that an exosome-based scoring model, Ovarian Cancer Score (OCS), outperformed CA125 in sensitivity for detecting FIGO stage I ovarian cancer. Notably, OCS results correlated well with FIGO stage and demonstrated improved sensitivity over CA125, particularly in early-stage ovarian cancer, suggesting its potential for recurrence surveillance. This study proposes to develop and validate a new exosome-based scoring model for post-treatment surveillance of recurrence in ovarian cancer, aiming to explore the potential of exosomal biomarkers in cancer recurrence monitoring and ultimately provide clinicians with an effective surveillance tool for ovarian cancer recurrence management.
The study consists of two stages and plans to prospectively enroll 200 patients with epithelial ovarian cancers. In stage I, enrolled patients will be categorized into relapse and non-relapse groups based on their imaging-confirmed recurrence status. Serum exosomal protein profiles obatined from their blood samples will be used for model development. In stage II, patients in the relapse group will undergo standard clinical management with follow-up visits every 3 months. Serum exosomal protein profiles obatined from them will be used for model validation. Overall, blood samples will be collected at enrollment (baseline), after surgery prior to adjuvant chemotherapy (if applicable), during adjuvant chemotherapy or systemic chemotherapy, after adjuvant chemotherapy prior to follow-up visits, and at several time points during follow-up visits. Follow-up visits will continue until either patients experience an ovarian cancer recurrence or the predetermined endpoint of follow-up visits (18 months) is reached. In stage I, logistic regression model will be used to draw a ROC curve and the Youden index will be used to select the most suitable cutoff value. In stage II, sensitivity, specificity, PPV and NPV will be calculated based on results of the model and imaging-confirmed recurrence status. All data will be processed via SPSS 23.0, GraphPad PRISM version 8.0, and R version 4.4.0.
- Conditions
- Ovarian Cancer
- Being tested
- Not applicable- observational study
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
This is an observational cohort study with no planned interventions. Participants will be followed over multiple time points to evaluate treatment outcomes based on the standard care process.
| Study group | Role | What they receive |
|---|---|---|
| Single Cohort | Not described Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
The length of time from the date of the end of adjuvant threapy to the date of the first loco-regional or systemic recurrence
Measured: From the end of adjuvant threapy to the end of follow-up visits at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion31 Dec 2027 (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.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaohua Wu MD [zzhong], Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925126
- Sponsor's protocol ID
- 2501-Exp131
- Status last verified
- Apr 2025
- First submitted
- 6 Apr 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exosome-based Scoring Model for Post-treatment Surveillance of Recurrence in Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06925126
- Acronym / sponsor ID
- 2501-Exp131
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Apr 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.
The goal of this observational study is to develop an exosome-based scoring model for post-treatment surveillance of recurrence in ovarian cancer. The main questions it aims to answer are:
- Does this model have the potential for ovarian cancer recurrence monitoring?
- Can this model demonstrate superior performance to CA125 for ovarian cancer recurrence monitoring?
Participants will :
- Provide serial blood samples at predefined times
- Undergo standardized imaging and clinical assessments during follow-up visits
Detailed description
Ovarian cancer is the most lethal gynecologic malignancy with the lowest survival rate among the three major gynecological malignancies. Over 70% of ovarian cancer patients experience recurrence within three years after initial treatment, making treatment response prediction and recurrence monitoring during treatment phases and follow-up visits particularly crucial. CA125 remains the primary recommended biomarker for ovarian cancer recurrence surveillance in current national and international guidelines, while its suboptimal performance necessitates further improvements.
Clinical trial data demonstrated that an exosome-based scoring model, Ovarian Cancer Score (OCS), outperformed CA125 in sensitivity for detecting FIGO stage I ovarian cancer. Notably, OCS results correlated well with FIGO stage and demonstrated improved sensitivity over CA125, particularly in early-stage ovarian cancer, suggesting its potential for recurrence surveillance. This study proposes to develop and validate a new exosome-based scoring model for post-treatment surveillance of recurrence in ovarian cancer, aiming to explore the potential of exosomal biomarkers in cancer recurrence monitoring and ultimately provide clinicians with an effective surveillance tool for ovarian cancer recurrence management.
The study consists of two stages and plans to prospectively enroll 200 patients with epithelial ovarian cancers. In stage I, enrolled patients will be categorized into relapse and non-relapse groups based on their imaging-confirmed recurrence status. Serum exosomal protein profiles obatined from their blood samples will be used for model development. In stage II, patients in the relapse group will undergo standard clinical management with follow-up visits every 3 months. Serum exosomal protein profiles obatined from them will be used for model validation. Overall, blood samples will be collected at enrollment (baseline), after surgery prior to adjuvant chemotherapy (if applicable), during adjuvant chemotherapy or systemic chemotherapy, after adjuvant chemotherapy prior to follow-up visits, and at several time points during follow-up visits. Follow-up visits will continue until either patients experience an ovarian cancer recurrence or the predetermined endpoint of follow-up visits (18 months) is reached. In stage I, logistic regression model will be used to draw a ROC curve and the Youden index will be used to select the most suitable cutoff value. In stage II, sensitivity, specificity, PPV and NPV will be calculated based on results of the model and imaging-confirmed recurrence status. All data will be processed via SPSS 23.0, GraphPad PRISM version 8.0, and R version 4.4.0.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Cohort | – | Other: Not applicable- observational study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with recurrent epithelial ovarian cancer who treated in the Fudan University Shanghai Cancer Center
Key inclusion criteria (5 listed)
- Women aged ≥ 18 years
- Pathologic confirmed stage I-IV epithelial ovarian cancer, with ≤2 prior lines of therapy (maintenance therapy is not counted as a line of treatment), platinum-sensitive recurrence (achieved complete/partial response [CR/PR] after last platinum-based chemotherapy, with a platinum-free interval >6 months), and radiologically confirmed recurrent disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- A life expectancy of at least 6 months
- Written informed consent
Key exclusion criteria (4 listed)
- Patients with non-epithelial tumors
- Patients with history of other malignancies within the past 5 years (except completely resected basal cell carcinoma or squamous cell carcinoma of the skin)
- Women who are pregnant, lactating, or intend to become pregnant during the study period
- Patients who refuse to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studyThis is an observational cohort study with no planned interventions. Participants will be followed over multiple time points to evaluate treatment outcomes based on the standard care process. | Other | Single Cohort |
Primary outcome
Recurrence-free survival
Time frame: From the end of adjuvant threapy to the end of follow-up visits at 18 months
The length of time from the date of the end of adjuvant threapy to the date of the first loco-regional or systemic recurrence
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 13 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Fudan University.
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 5 inclusion and 4 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 13 Apr 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?
Contact Zheng Feng (86-21-64175590-81000, lizfeng1231@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (time frame: From the end of adjuvant threapy to the end of follow-up visits at 18 months). 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 13 Apr 2025.