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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03614689

Enrollment

104

Registered

2018-08-03

Start date

2017-11-25

Completion date

2024-12-31

Last updated

2024-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

China

Outcome results