Assessment of Prognosis Using Peripheral Blood Circulating Tumor DNA in Patients With Cervical Cancer
Study Details
Study Description
Brief Summary
This observational study is conducted to assess the value of using peripheral blood ctDNA to detect dynamic changes in HPV and genetic variants in predicting the prognosis of patients with locally advanced cervical cancer, as compared with traditional imaging and tumor markers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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. |
Other: 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. |
Other: 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.
|
Outcome Measures
Primary Outcome Measures
- Progression Free Survival (PFS) [Two years]
Assess PFS in ctDNA HPV and genetic variants clearance versus not clearance
Secondary Outcome Measures
- Overall Survival (OS) [Two years]
Assess OS in ctDNA HPV and genetic variants clearance versus not clearance
- Recurrence prediction performance of ctDNA dynamic changes [Two years]
Performance of dynamic changes of HPV copy number and genetic variation in ctDNA in predicting recurrence compared with imaging and serum tumor markers
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Not receiving systemic treatment
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Pathological diagnosis: cervical squamous cell carcinoma
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Aged 18-70 years
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ECOG PS: 0-1
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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:
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Patients diagnosed with other malignancies within 5 years
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Patients had received previous systemic antitumor therapy
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In the judgment of the investigator, the patients had other factors that might have caused the study to be discontinued
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fudan University Shanghai Cancer Center | Shanghai | China | 200023 |
Sponsors and Collaborators
- Fudan University
- Amoy Diagnostics Co., LTD
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LACC-BD-1