Exosome-based Recurrence Score for Post-Treatment Ovarian Cancer

NCT06925126 | Not Yet Recruiting

• 1 other identifier: 2501-Exp131
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Does this model have the potential for ovarian cancer recurrence monitoring?
2. 2.Can this model demonstrate superior performance to CA125 for ovarian cancer recurrence monitoring?
3. 3.Provide serial blood samples at predefined times
4. 4.Undergo standardized imaging and clinical assessments during follow-up visits

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  From the end of adjuvant threapy to the end of follow-up visits at 18 months

Study Arms (1)

Single Cohort

Other: Not applicable- observational study

Interventions

Not applicable- observational study OTHER

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.

Single Cohort

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Ovarian cancer affects only biological females, as ovaries are part of the female reproductive system. Thus, research focuses on this population to ensure findings are relevant and applicable to those at risk.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Zheng Feng

CONTACT

86-21-64175590-81000; lizfeng1231@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gynecological Oncology

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: April 13, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 13, 2025

Record last verified: 2025-04