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NCT Number: NCT07153705

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. OCS product inspection

    Time frame: Before the operation

Sponsors and collaborators

Lead sponsor

Beihua Kong

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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