Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring

Cervical Cancer Clinical Trial

Official title:

Liquid Biopsies - a Possible Tool for Treatment Monitoring and Early Recurrence Detection in HPV-associated Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05774561
• Other study ID #: NU-23-03-00255
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 1, 2026

Study information

• Verified date: March 2023
• Source: The Institute of Molecular and Translational Medicine, Czech Republic
• Contact: Marian Hajduch, MD., PhD.
• Phone: +420 585 632 083
• Email: marian.hajduch[@]upol.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial will evaluate the possible benefits and the performance of liquid biopsies in HPV-associated cancer treatment monitoring. This study aims to find a combination of an adequately sensitive and specific sampling method and biomarkers for early risk stratification of disease recurrence.

Description:

Although the cancers associated with human papillomavirus (HPV) infection are currently almost entirely preventable, a significant part of the Czech population suffers from these diseases. The most common HPV-associated cancers are cervical cancer (CC) and oropharyngeal cancer (OPC). In these, the severe problem is successful monitoring of the treatment effectiveness and early disease recurrence detection. It is, therefore, necessary to find a non-invasive method that could specifically and timely identify patients at risk of recurrence and thus enable patients with quality and less burdensome medical care. The use of liquid biopsies (LB), which the study focuses on, looks most promising. This study is divided into two arms, with each arm including both prospective and retrospective parts. Into prospective parts will be enrolled only newly diagnosed CC/HSIL (high-grade cervical intraepithelial lesions) or OPC patients. In contrast, the retrospective part will enroll patients in post-treatment follow-up. In both study arms, fresh tumor tissues will be sampled from patients in prospective parts before treatment, and archived Formalin Fixed Paraffin Embedded (FFPE) tissue samples will be obtained from patients of retrospective parts. Regarding the liquid biopsies, pre & post-treatment sampling of LB will be performed. Subsequently, regular sample acquisition will be performed during follow-up according to the standard medical practice in both prospective and retrospective parts. Oropharyngeal swabs, gargle lavage,exhaled breath condensate (EBC), and blood samples will be collected from OPC patients. Blood collection and self-sampling of cervicovaginal swabs will be performed in patients with CC/HSIL. All samples, excluding blood samples, will be tested for the presence of the most prevalent high-risk and low-risk HPV genotypes. The circulating tumor (ct) HPV DNA will be monitored in blood samples. Additionally, the mutation profile of the primary tumors will be examined in fresh and FFPE samples. The dynamics of HPV DNA will be monitored throughout all follow-up samples and correlated with the obtained clinical data. A created panel of frequently altered genes will be used for alterations monitoring in liquid biopsies. In the final analysis of laboratory and clinical results, we assume a finding of a clinically usable algorithm that could predict the risk of disease recurrence for a particular patient.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: December 1, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

Women diagnosed with CC/HSIL. Men and women diagnosed with OPC. Patients must agree with study enrollment and must sign study informed consent. Exclusion Criteria: No exclusion criteria are set.

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Dysplasia
• Cervical Intraepithelial Neoplasia
• Human Papillomavirus Infection
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms
• Papillomavirus Infections
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Intervention

Diagnostic Test:
• Arm A - Diagnostic test: HPV detection in liquid biopsies
Patients will be asked to perform self-collection of gargle lavage samples. Oropharyngeal swabs, breath condensate, and blood samples will be taken by trained clinicians.
• Arm B - Diagnostic test: HPV detection in liquid biopsies
Patients will be asked to perform cervicovaginal self-sampling using Evalyn Brush. Blood samples will be taken by trained clinicians.

Locations

Country	Name	City	State
Czechia	University Hospital Olomouc	Olomouc

Sponsors (3)

Lead Sponsor	Collaborator
The Institute of Molecular and Translational Medicine, Czech Republic	Cancer Research Czech Republic, University Hospital Olomouc

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamics of HPV infection in cervical cancer patients during 4-year follow-up.	HPV-status in liquid biopsies collected during pre-treatment, post-treatment and follow-up check-ups.	4 years
Primary	Dynamics of HPV infection in oropharyngeal cancer patients during 4-year follow-up.	HPV-status in liquid biopsies collected during pre-treatment, post-treatment and follow-up check-ups.	4 years
Primary	Dynamics of circulating tumor (ct) HPV DNA in oropharyngeal cancer patients.	Correlation of plasmatic ct HPV DNA level with cancer patient´s prognosis.	4 years
Primary	Dynamics of circulating tumor (ct) HPV DNA in cervical cancer patients	Correlation of plasmatic ct HPV DNA level with patient´s prognosis	4 years
Primary	Analysis of the mutational landscape of oropharyngeal cancer cases.	Correlation of tumor mutational burden (TMB) with cancer patient´s prognosis.	4 years
Primary	Analysis of the mutational landscape of cervical cancer cases.	Correlation of tumor mutational burden (TMB) with cancer patient´s prognosis.	4 years