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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

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

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Time frame: 2 years

Secondary outcomes

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.

Time frame: 1 years

Sponsors and collaborators

Lead sponsor

Geneplus-Beijing Co. Ltd.

Industry

Collaborators

Peking Union Medical College Hospital

Registry information

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2024
First posted: Aug 3, 2018
Registry last updated: Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting