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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03614689
• Other study ID #: RN2017090101
• Status: Active, not recruiting
• Start date: November 25, 2017
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Geneplus-Beijing Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 104
• Est. completion date: June 2024
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Neoplasm, Residual
• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing
China	Peking University International Hospital	Beijing
China	Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University	Changsha	Hunan
China	Sichuan Cancer Hospital	Chengdu	Sichuan
China	Affiliated Cancer Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
Geneplus-Beijing Co. Ltd.	Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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