Exosome-based Recurrence Score for Post-Treatment Ovarian Cancer

April 6, 2025 updated by: Xiaohua Wu MD [zzhong], Fudan University

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:

  1. Does this model have the potential for ovarian cancer recurrence monitoring?
  2. Can this model demonstrate superior performance to CA125 for ovarian cancer recurrence monitoring?

Participants will :

  1. Provide serial blood samples at predefined times
  2. Undergo standardized imaging and clinical assessments during follow-up visits

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with recurrent epithelial ovarian cancer who treated in the Fudan University Shanghai Cancer Center

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single Cohort
Other: Not applicable- observational study
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the end of adjuvant threapy to the end of follow-up visits at 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 6, 2025

First Submitted That Met QC Criteria

April 6, 2025

First Posted (Actual)

April 13, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2025

Last Update Submitted That Met QC Criteria

April 6, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2501-Exp131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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