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

NCT ID: NCT03614689

Last Updated: 2024-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-25

Study Completion Date

2024-12-31

Brief Summary

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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

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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).

Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

Geneplus-Beijing Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Changsha, Hunan, China

Site Status

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Site Status

Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status

Peking Union Medical College Hospital

Beijing, , China

Site Status

Peking University International Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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RN2017090101

Identifier Type: -

Identifier Source: org_study_id

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