Assessment of Prognosis Using Peripheral Blood Circulating Tumor DNA in Patients With Cervical Cancer
NCT ID: NCT05602831
Last Updated: 2022-11-02
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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UNKNOWN
108 participants
OBSERVATIONAL
2022-08-10
2024-08-31
Brief Summary
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Detailed Description
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Two cohorts will be enrolled: operable group and radical chemoradiotherapy group.
After enrollment, patients will receive standard treatment and follow-up strategy. Peripheral blood samples will be collected from 2 cohorts of patients before treatment and at different time points after starting treatment. Baseline surgical or puncture tissues will be also obtained.
Peripheral blood ctDNA and baseline tissues will be tested for HPV copy number based on ddPCR and genetic variation based on next-generation sequencing (NGS).
Finally, the correlation of ctDNA HPV and genetic variation clearance with patients prognosis and its value for recurrence monitoring compared to traditional tumor markers and imaging examination will be analyzed.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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operable treatment group
After enrollment, patients will receive standard treatment and conventional follow-up strategy.
Peripheral blood samples will be collected before treatment and at different time points after starting treatment.
Baseline surgical tissue will be also obtained.
detect HPV and genetic variants
Serum tumor markers and ctDNA HPV and genetic variants will be detected in peripheral blood samples. HPV and genetic variants will be also detected in baseline surgical tissues.
radical chemoradiotherapy group
After enrollment, patients will receive standard treatment and conventional follow-up strategy.
Peripheral blood samples will be collected before treatment and at different time points after starting treatment.
Baseline puncture tissue will be also obtained before radical chemoradiotherapy.
detect HPV and genetic variants
Serum tumor markers and ctDNA HPV and genetic variants will be detected in peripheral blood samples. HPV and genetic variants will be also detected in baseline puncture tissues.
Interventions
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detect HPV and genetic variants
Serum tumor markers and ctDNA HPV and genetic variants will be detected in peripheral blood samples. HPV and genetic variants will be also detected in baseline surgical tissues.
detect HPV and genetic variants
Serum tumor markers and ctDNA HPV and genetic variants will be detected in peripheral blood samples. HPV and genetic variants will be also detected in baseline puncture tissues.
Eligibility Criteria
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Inclusion Criteria
* Not receiving systemic treatment
* Pathological diagnosis: cervical squamous cell carcinoma
* Aged 18-70 years
* ECOG PS: 0-1
* Patients volunteer to participate in this study and sign the informed consent, with good compliance, and cooperate with the acquisition of tissue samples and blood samples
Exclusion Criteria
* Patients had received previous systemic antitumor therapy
* In the judgment of the investigator, the patients had other factors that might have caused the study to be discontinued
18 Years
70 Years
FEMALE
No
Sponsors
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Amoy Diagnostics
INDUSTRY
Fudan University
OTHER
Responsible Party
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Xiaohua Wu MD
Director of Gynecologic Oncology
Locations
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Fudan University Shanghai Cancer Center
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LACC-BD-1
Identifier Type: -
Identifier Source: org_study_id
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