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

Locally Advanced Cervical Cancer Clinical Trial

Official title:

Using Peripheral Blood Circulating Tumor DNA (ctDNA) Based Human Papillomavirus (HPV) and Genetic Variant Test to Assess the Prognosis of Surgery or Radical Chemoradiotherapy in Patients With Locally Advanced Cervical Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05602831
• Other study ID #: LACC-BD-1
• Status: Recruiting
• Start date: August 10, 2022
• Est. completion date: August 2024

Study information

• Verified date: October 2022
• Source: Fudan University
• Contact: Hao Wen, MD
• Phone: +86-021-64175590
• Email: wenhao[@]shca.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	Amoy Diagnostics Co., LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	Assess PFS in ctDNA HPV and genetic variants clearance versus not clearance	Two years
Secondary	Overall Survival (OS)	Assess OS in ctDNA HPV and genetic variants clearance versus not clearance	Two years
Secondary	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	Two years