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

NCT ID: NCT06025045

Last Updated: 2023-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2025-08-01

Brief Summary

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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

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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.

Conditions

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Ovarian Cancer Stage IV Ovarian Cancer Stage III

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Shihejiyin Technology, Inc.

INDUSTRY

Sponsor Role collaborator

Jing Li

OTHER

Sponsor Role lead

Responsible Party

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Jing Li

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jing Li, Prefessor

Role: CONTACT

15915893493

Facility Contacts

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Jing Li, Professor

Role: primary

15915893493

Other Identifiers

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SunYatsen202309

Identifier Type: -

Identifier Source: org_study_id

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