OCS Products Based on Exosome Technology Were Applied in the Recurrence Monitoring Study After the Initial Treatment of Baseline CA125-negative Ovarian Cancer

NCT07153705 | Not Yet Recruiting

• 1 other identifier: CM-2401
• Study Type: observational
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief 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 treatment.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• OCS product inspection

  Before the operation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ovarian cancer

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beihua Kong: 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: archiater

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 4, 2025
• Study Start: September 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08