Assessment of the Minimal Residual Disease in Ovarian Cancer From Circulating Tumor DNA and Immune Repertoire

Active, not recruiting

• Conditions: Ovarian Cancer

• Registration Number: NCT03614689
• Lead Sponsor: Geneplus-Beijing Co. Ltd.

Brief Summary

To analyze the proportion of hereditary tumors in ovarian cancer patients in China, as well as the spectrum of variations; the ctDNA characteristics in patients with ovarian cancer; the correlation between the clonal status of mutations and therapy response; whether ctDNA detection can be used to predict the risk of ovarian cancer recurrence; and the characteristics of immune repertoire before and after treatment in patients with ovarian cancer.

Detailed Description

100 OC cases with available matched tumor DNA and plasma will be collected. All patients will be treated according to clinical guidelines, and receive circulating tumor DNA (ctDNA) liquid biopsy at the time of diagnosis, at mid treatment, at the end of treatment and during follow-up. The study will be ended when the patients have progressive disease (PD) or reach the longest follow-up time (2 years).

Study Timeline

• Study Start: 2017-11-25
• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-08-03
• Primary Completion: 2020-11-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-18
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 104

Inclusion Criteria

• Patients who have not received treatment including radiotherapy, chemotherapy, and surgery.
• Expected to achieve satisfactory tumor cytoreductive surgery.
• Estimated lifetime is more than 3 months.
• Understand the research plan and voluntarily participate in the study, sign the informed consent form.
• Ability to collect specimens from each time point and provide corresponding clinical information.

Exclusion Criteria

• Patients who will receive new adjuvant therapy.
• Patients who have other primary cancer.
• Pregnant or breast-feeding woman.
• Patients with severe mental illness.
• Patients achieve unsatisfactory tumor cytoreductive surgery.
• Patients who voluntarily withdraw for any reason.
• Patients who cannot complete the research plan.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The ctDNA characteristics in patients with ovarian cancer , the correlation between the clonal status of mutations and therapy response and whether ctDNA detection can be used to predict the risk of ovarian cancer recurrence.	2 years

Secondary Outcome Measures

Name	Time	Method
The proportion of hereditary tumors in ovarian cancer patients in China, as well as the spectrum of variations and the characteristics of immune repertoire before and after treatment in patients with ovarian cancer.	1 years

Trial Locations

Locations (6)

Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University; 🇨🇳 Changsha, Hunan, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, China

Sichuan Cancer Hospital; 🇨🇳 Chengdu, Sichuan, China

Affiliated Cancer Hospital of Xinjiang Medical University; 🇨🇳 Ürümqi, Xinjiang, China

Peking University International Hospital; 🇨🇳 Beijing, China

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China