Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring

Trial Title: Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring

NCT ID: NCT05774561

Condition: Cervical Cancer
Cervical Dysplasia
Oropharyngeal Cancer
Human Papillomavirus Infection

Conditions: Official terms:
Papillomavirus Infections
Uterine Cervical Neoplasms
Oropharyngeal Neoplasms
Uterine Cervical Dysplasia

Conditions: Keywords:
human papillomavirus
HPV
liquid biopsies
cervicovaginal swab
cervical cancer
oropharyngeal cancer

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: Arm A - Diagnostic test: HPV detection in liquid biopsies
Description: 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 group label: Arm A - Oropharyngeal cancer patients

Intervention type: Diagnostic Test
Intervention name: Arm B - Diagnostic test: HPV detection in liquid biopsies
Description: Patients will be asked to perform cervicovaginal self-sampling using Evalyn Brush. Blood samples will be taken by trained clinicians.
Arm group label: Arm B - Cervical cancer patients

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.

Detailed 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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Locations:

Facility:
Name: University Hospital Olomouc

Address:
City: Olomouc
Zip: 77900
Country: Czechia

Status: Recruiting

Contact:
Last name: Marian Hajduch, MD, PhD.

Phone: +420 585 632 083
Email: marian.hajduch@upol.cz

Contact backup:
Last name: Vladimira Koudelakova, MSc., PhD.

Phone: +420 585 632 089
Email: vladimira.koudelakova@upol.cz

Investigator:
Last name: Radovan Pilka, prof. MD,PhD
Email: Principal Investigator

Investigator:
Last name: Richard Salzman, MD, PhD.
Email: Principal Investigator

Start date: June 1, 2022

Completion date: December 1, 2026

Lead sponsor:
Agency: The Institute of Molecular and Translational Medicine, Czech Republic
Agency class: Other

Collaborator:
Agency: Cancer Research Czech Republic
Agency class: Other

Collaborator:
Agency: University Hospital Olomouc
Agency class: Other

Source: The Institute of Molecular and Translational Medicine, Czech Republic

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05774561