HPV Serum Level and FDG PET CT in Patients With Cervical Cancer Treated With Radical Radiochemotherapy (HPV-RICCO)

January 4, 2024 updated by: The Greater Poland Cancer Centre

HPV Serum Level and FDG PET CT in Patients With Cervical Cancer Treated With Radical Radiochemotherapy (HPV-RICCO - HPV Relation in Cervical Cancer Outcomes)

The main purpose of the study is to describe changes in plasma HPV DNA levels in patients with locally advanced cervical cancer during radical radiochemotherapy (CRT) and to correlate changes with response to treatment. Monitoring of the response to treatment will also be assessed in FDG PET CT imaging.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Ninety-five per cent of cervical cancer cases are caused by persistent infections with carcinogenic HPVs. Locally advanced stage IB2 to IVA cervical cancers are treated with definitive chemoradiation therapy (CRT). Despite known clinical prognostic factors of poor treatment outcome such as advanced stage and positive nodal status, we still don't know predictors of relapse.

HPV status will be assessed in the neoplastic tissue and DNA from the blood serum of patients with cervical cancer will be isolated and analyzed by real-time PCR. Plasma HPV DNA would identify patients with residual disease after CRT due to persistent detectable HPV. This would earlier detect high risk patients who would benefit from adjuvant therapy.

While metabolic response in post - therapy FDG PET CT is predictive of survival, there is usually 3 months waiting period time needed to perform this imaging. This pilot study will provide preliminary estimates of the correlation between plasma HPV DNA level, PET finding and clinical outcome in polish cervical cancer patients.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Greater Poland
      • Poznan, Greater Poland, Poland, 61-866
        • Greater Poland Cancer Centre / Oncological Gynecology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Age Limits: more than 18Y Histologically confirmed squamous cell carcinoma, FIGO stage IB-IVA planned for radical radiochemotherapy Eastern Cooperative Oncology Group (ECOG) performance status 0,1,2

Exclusion Criteria:

Patients who have received any anticancer treatment for their cervical cancer. Eastern Cooperative Oncology Group (ECOG) performance status > 2 Other cervical cancer tumor histologies (e.g. small cell, serous) Contraindications to 18FDG PET-CT Contraindication to radiochemotherapy Known pregnancy or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: One-Arm HPV serum level and FDG PET CT
HPV serum level and FDG PET CT in patients with cervical cancer treated with radical radiochemotherapy
Diagnostic test: HPV serum level and FDG PET CT in patients with cervical cancer treated with radical radiochemotherapy

Locally advanced non-operable newly diagnosed FIGO stage IB-IVA cervical cancer patients planned for definitive radiochemotherapy will be accrued to study and will have:

  1. FDG PET Scan before treatment and 3 months after treatment
  2. Pre- treatment DNA from the neoplastic time preserved in the form of paraffin blocks to determine HPV status
  3. Blood sample to measure HPV DNA at time point baseline (before treatment), in the middle of treatment and at the end of definitive radiochemotherapy,
  4. [F-18] - FDG PET scan before treatment and 3 months post completion of radiochemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
local control
Time Frame: 18 months
18 months
Response to treatment
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: 18 months
18 months
Plasma HPV DNA levels
Time Frame: Up to 3 months
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Greater Poland Cancer Centre

Investigators

  • Principal Investigator: Ewa Burchardt, PhD, MD, Oncological Gynecology Clinic / GPCC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Actual)

May 31, 2022

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

December 21, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (Actual)

December 24, 2020

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15/06/2020/E/WCO/007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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