Bespoke ctDNA Assay for Recurrence and Treatment Response Monitoring in Advanced Epithelial Ovarian Cancer
NCT ID: NCT05446545
Last Updated: 2023-12-28
Study Results
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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RECRUITING
139 participants
OBSERVATIONAL
2021-09-01
2026-12-31
Brief Summary
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Detailed Description
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To evaluate ctDNA dynamics, tumor tissue collected from surgery will be sequenced with whole-exome sequencing (WES) to design patient-specific 16-plex panel. At planned monitoring timepoints, blood samples will be drawn, and ctDNA will be sequenced with ultra-deep ctDNA high-throughput sequencing methods.
Traditional surveillance methods will be applied as comparison, including but not limited to carbohydrate antigen 125 (CA-125)/ human epididymal protein 4 (HE4)/ carcinoembryonic antigen (CEA)/ carbohydrate antigen 199 (CA199), etc., as well as standard imaging.
Survival analyses will be conducted based on ctDNA status (positive/negative) after surgery. Recurrence rate of each subgroup, positive predictive values and negative predictive values etc. will be examined. Changes in ctDNA levels (ΔctDNA) during treatment will be used to evaluate the efficacy of maintenance therapy comparing traditional biomarkers,
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ND-EOC or platinum-sensitive rEOC
1. Newly diagnosed patients with advanced EOC (ND-EOC) who are eligible for radical surgery.
2. Patients relapsed from platinum-based therapy (rEOC) who are eligible for secondary cytoreductive surgery.
ND-EOC or platinum-sensitive rEOC
platinum-based combined chemotherapy or bevacizumab will be used for adjuvant treatment, followed by maintenance therapy with poly adenosine diphosphate-ribose polymerase (PARP) inhibitor, or bevacizumab, or other anti-tumor angiogenesis drugs or immune checkpoint inhibitors
Interventions
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ND-EOC or platinum-sensitive rEOC
platinum-based combined chemotherapy or bevacizumab will be used for adjuvant treatment, followed by maintenance therapy with poly adenosine diphosphate-ribose polymerase (PARP) inhibitor, or bevacizumab, or other anti-tumor angiogenesis drugs or immune checkpoint inhibitors
Eligibility Criteria
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Inclusion Criteria
2. Patients with advanced epithelial ovarian cancer who are eligible for radical surgery;
3. Patients with advanced epithelial ovarian cancer relapsed from platinum-based therapies and eligible for secondary cytoreductive surgery;
4. The subjects agree to sign the informed consent and agree to use their samples and data for related scientific research;
5. Subjects agree to collect tissue samples and peripheral blood samples for whole exon sequencing and ctDNA monitoring.
Exclusion Criteria
2. Patients in pregnancy;
3. Patients with a history of blood transfusion within 3 months before enrollment;
4. Newly diagnosed patients who only received laparoscopic surgery;
5. Patients received chemotherapy or other anti-tumor therapy before surgery.
18 Years
70 Years
FEMALE
No
Sponsors
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BGI Tianjin
INDUSTRY
Fudan University
OTHER
Responsible Party
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Zhong Zheng MD
Director of Gynecologic Oncology
Locations
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Hao Wen
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Hao Wen, Dr
Role: primary
Other Identifiers
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2021-39-2342
Identifier Type: -
Identifier Source: org_study_id