Prognostic Value of MRD Detection in CA125 Non-sensitive Ovarian Cancer Patients

NCT06182917 | Recruiting

• 1 other identifier: WCSUH20231108
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Ovarian cancer ranks third in the incidence of gynecologic malignancies, while mortality ranks first. The tumor marker CA125 is the most concerned tumor marker in the clinical monitoring prognosis of ovarian cancer, and an elevated CA125 indicates a later stage and a worse prognosis. However about 20% of patients with ovarian cancer have low CA125 expression. Therefore, CA125 is not sensitive to some ovarian cancers with a high risk of recurrence. How to improve the diagnostic performance of these CA125-insensitive patients is a difficult problem in current research. Minimal residual disease (MRD) refers to the residual tumor components in the body of tumor patients after achieving complete remission through treatment. MRD detection is mainly achieved by liquid biopsy, and residual tumor components can be detected by circulating tumor DNA (ctDNA). This study aims to explore the value of MRD (ctDNA) in the risk assessment of CA125 non sensitive ovarian cancer populations by combining ctDNA with traditional imaging and serological tumor markers.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• The prognostic value of MRD

  The sensitivity of MRD in CA125 low level ovarian patients.

  12 months

Secondary Outcomes (1)

• Progress Free Survival

  From date of the beginning of therapy to disease metastasis or recurrence due to any cause,assessed up to 24 months

Study Arms (1)

ctDNA alternation during the treatment of Ovarian cancer

Tumor samples of included patients were detected by WES, and 16 major clonal mutation sites were screened for the personalized monitoring panel. All patients received blood ctDNA detection to monitor the major clonal alternation after 3 cycels treatment or 3 months after therapy, at the same time, the detection of serum tumor markers (CA125) and imaging examination were carried out, in order to evaluate the MRD detection efficiency.

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study intends to include 35 patients with low CA125 level ovarian cancer at first diagnosis or recurrence between the ages of 18-75 years old.

You may qualify if:

• Age 18-75;
• Pathologically confirmed ovarian cancer;
• CA125 ≤200U/ml at first diagnosis or recurrence;
• Physical condition score PS ≤ 2 points;
• Enough tumor samples for WES detection;
• Patients and their families can understand and are willing to participate in this study and provide written informed consent.

You may not qualify if:

• Patients unable to provide sufficient tissue / blood samples for research detection;
• Pregnant or lactating women;
• Other diseases considered by the research doctor to affect the prognosis and survival;

Sponsors & Collaborators

• West China Second University Hospital: lead

Study Sites (1)

west china second University， SICHUAN University, China

Chengdu, Sichuan, 610016, China

RECRUITING

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 Officials

• Mengpei Zhang

  West China Second University Hospital

  PRINCIPAL INVESTIGATOR

• Rui Li

  West China Second University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rutie Yin

CONTACT

028-88570403; yrtt2013@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: West China Second University Hospital

Study Record Dates

• First Submitted: November 25, 2023
• First Posted: December 27, 2023
• Study Start: October 1, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 27, 2023

Record last verified: 2023-12

Locations

CN (1)