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

Fudan University

Status: Enrolling

Conditions: Locally Advanced Cervical Cancer

Treatments: Other: detect HPV and genetic variants

Study type: Observational

Funder types: Other

Identifiers

NCT05602831

LACC-BD-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

108 participants in 2 patient groups

operable treatment group

Description:

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.

Treatment:

Other: detect HPV and genetic variants

Other: detect HPV and genetic variants

radical chemoradiotherapy group

Description:

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.

Treatment:

Other: detect HPV and genetic variants

Other: detect HPV and genetic variants