Dynamic Monitoring of ctDNA Predicts Recurrence of Advanced Ovarian Cancer After Primary Treatments

Sponsor

Jing Li (Other)

Overall Status

Recruiting

CT.gov ID

NCT06025045

Collaborator

Nanjing Shihejiyin Technology, Inc. (Industry)

Enrollment

Location

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients who receive satisfactory PDS, currently the change in CA125 during chemotherapy can only be used to evaluate the effectiveness of chemotherapy. This study plans to use ctDNA dynamic monitoring to detect minimal residual lesions during treatment, to demonstrate the application value of ctDNA dynamic monitoring in predicting the recurrence of ovarian cancer after PDS/IDS surgery.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer Stage IV Ovarian Cancer Stage III

Detailed Description

This study plans to include ovarian cancer patients who have undergone PDS/IDS surgery. By analyzing the surgical tissue samples of ovarian cancer patients, we aim to identify risk factors related to the prognosis and recurrence of ovarian cancer. By monitoring the ctDNA status after PDS surgery, we analyze the role of ctDNA-MRD in predicting postoperative recurrence of ovarian cancer. By monitoring the MRD status at the end of the 3rd cycle of adjuvant chemotherapy and at the end of adjuvant treatment, we analyze the predictive role of serial cDNA-MRD for the efficacy of adjuvant treatment, providing a basis for determining the number of cycles of adjuvant treatment after PDS.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Dynamic Monitoring of ctDNA Predicts Recurrence of Advanced Ovarian Cancer After Primary Treatments

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Aug 1, 2025

Outcome Measures

Primary Outcome Measures

2 years DFS rate [2 years]
The recurrence rate of patients at two years after surgery

Secondary Outcome Measures

DFS [2 years]
Disease-free survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

≥ 18 years old.
Patients diagnosed with stage IIIC-IVA ovarian cancer through pathological examination.
The participant has read and fully understands the patient information, and has signed the informed consent form.
The patient is willing to undergo primary debulking surgery (PDS) or interval debulking surgery（IDS）. -

Exclusion Criteria:

Other tumors have been detected within the last 5 years.
Organ transplant recipients or those who previously had non-autologous (allogeneic) bone marrow or stem cell transplants.
Patients was deemed unsuitable to participate in this study by other researchers.
Patients who have previously received neoadjuvant chemotherapy or targeted therapy.