Assessment of the Minimal Residual Disease in Ovarian Cancer From Circulating Tumor DNA and Immune Repertoire
1 other identifier
observational
104
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2017
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 25, 2017
CompletedFirst Submitted
Initial submission to the registry
July 30, 2018
CompletedFirst Posted
Study publicly available on registry
August 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJuly 18, 2024
July 1, 2024
3 years
July 30, 2018
July 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Eligibility Criteria
Patients with previously untreated Ovarian Cancer.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Geneplus-Beijing Co. Ltd.lead
- Peking Union Medical College Hospitalcollaborator
Study Sites (6)
Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Changsha, Hunan, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Peking Union Medical College Hospital
Beijing, China
Peking University International Hospital
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2018
First Posted
August 3, 2018
Study Start
November 25, 2017
Primary Completion
November 30, 2020
Study Completion
December 1, 2024
Last Updated
July 18, 2024
Record last verified: 2024-07