Assessment of Prognosis Using Peripheral Blood Circulating Tumor DNA in Patients With Cervical Cancer
Using Peripheral Blood Circulating Tumor DNA (ctDNA) Based Human Papillomavirus (HPV) and Genetic Variant Test to Assess the Prognosis of Surgery or Radical Chemoradiotherapy in Patients With Locally Advanced Cervical Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The goal of this study is to assess the prognostic value of ctDNA HPV and gene variant clearance in peripheral blood.
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Shanghai, China, 200023
- Recruiting
- Fudan University Shanghai Cancer Center
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Contact:
- Hao Wen, MD
- Phone Number: 81000 +862164175590
- Email: wenhao@shca.org.cn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Cohort A：Patients with initial diagnosis, operable locally advanced cervical cancer, FIGO stage IB2/3-IIA1/2.
Cohort B：Patients with initial diagnosis, receive radical chemoradiotherapy locally advanced cervical cancer, FIGO stage IIB-IVA.
Description
Inclusion Criteria:
- Patients with initial diagnosis, operable locally advanced cervical cancer, FIGO stage IB2/3-IIA1/2 or initial diagnosis, receive radical chemoradiotherapy locally advanced cervical cancer, FIGO stage IIB-IVA
- 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 diagnosed with other malignancies within 5 years
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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. |
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.
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.
|
|
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. |
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression Free Survival (PFS)
Time Frame: Two years
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Assess PFS in ctDNA HPV and genetic variants clearance versus not clearance
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Two years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival (OS)
Time Frame: Two years
|
Assess OS in ctDNA HPV and genetic variants clearance versus not clearance
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Two years
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Recurrence prediction performance of ctDNA dynamic changes
Time Frame: Two years
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Performance of dynamic changes of HPV copy number and genetic variation in ctDNA in predicting recurrence compared with imaging and serum tumor markers
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Two years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LACC-BD-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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