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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06025045

Enrollment

Registered

2023-09-06

Start date

2022-08-01

Completion date

2025-08-01

Last updated

2023-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer Stage III, Ovarian Cancer Stage IV

Keywords

ctDNA, Ovarian cancer, PDS, IDS, adjuvant chemotherapy

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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. ≥ 18 years old. 2. Patients diagnosed with stage IIIC-IVA ovarian cancer through pathological examination. 3. The participant has read and fully understands the patient information, and has signed the informed consent form. 4. The patient is willing to undergo primary debulking surgery (PDS) or interval debulking surgery（IDS）. -

Exclusion criteria

1. Other tumors have been detected within the last 5 years. 2. Organ transplant recipients or those who previously had non-autologous (allogeneic) bone marrow or stem cell transplants. 3. Patients was deemed unsuitable to participate in this study by other researchers. 4. Patients who have previously received neoadjuvant chemotherapy or targeted therapy.

Design outcomes

Primary

Measure	Time frame	Description
2 years DFS rate	2 years	The recurrence rate of patients at two years after surgery

Secondary

Measure	Time frame	Description
DFS	2 years	Disease-free survival

Countries

China

Contacts

Primary ContactJing Li, Prefessor

lijing228@mail.sysu.edu.cn15915893493

Outcome results