Assessment of Prognosis Using Peripheral Blood Circulating Tumor DNA in Patients With Cervical Cancer

Recruiting

• Conditions: Locally Advanced Cervical Cancer

• Registration Number: NCT05602831
• Lead Sponsor: Fudan University

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.

Study Timeline

• Study Start: 2022-08-10
• Status Verified: 2022-10
• Study First Submitted: 2022-10-28
• Study First Submitted QC: 2022-10-28
• Last Update Submitted: 2022-10-28
• Study First Posted: 2022-11-02
• Last Update Posted: 2022-11-02
• Primary Completion: 2024-07
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 108

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	Two years	Assess PFS in ctDNA HPV and genetic variants clearance versus not clearance

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China