Locally Advanced Cervical Cancer
Conditions
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.
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.
Interventions
OTHERdetect 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.
Sponsors
Amoy Diagnostics
Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Two years | Assess PFS in ctDNA HPV and genetic variants clearance versus not clearance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactHao Wen, MD
Outcome results
None listed