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| Name | Class |
|---|---|
| Amoy Diagnostics | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| detect HPV and genetic variants | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Assess PFS in ctDNA HPV and genetic variants clearance versus not clearance | Two years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Assess OS in ctDNA HPV and genetic variants clearance versus not clearance | Two years |
| Recurrence prediction performance of ctDNA dynamic changes | 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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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao Wen, MD | Contact | +86-021-64175590 | 81000 | wenhao@shca.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | 200023 | China |
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Tumor tissue and peripheral blood
| detect HPV and genetic variants | Other | 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. |
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| Two years |