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

NCT06025045 | Unknown

• 1 other identifier: SunYatsen202309
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer Stage IV; Ovarian Cancer Stage III

Keywords

ctDNA; Ovarian cancer; PDS; IDS; adjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• 2 years DFS rate

  The recurrence rate of patients at two years after surgery

  2 years

Secondary Outcomes (1)

• DFS

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Advanced ovarian cancer patients

You may qualify if:

• ≥ 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）. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jing Li: lead
• Nanjing Shihejiyin Technology, Inc.: collaborator

Study Sites (1)

Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma sample； tumor tissue; WBC

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

Central Study Contacts

Jing Li, Prefessor

CONTACT

15915893493; lijing228@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 6, 2023
• Study Start: August 1, 2022
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: September 6, 2023

Record last verified: 2023-08

Locations

CN (1)