HPV Serum Level and FDG PET CT in Patients With Cervical Cancer Treated With Radical Radiochemotherapy

NCT04683549 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-01-08

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • The Greater Poland Cancer Centre

    lead OTHER

Principal Investigators

  • Ewa Burchardt, PhD, MD · Oncological Gynecology Clinic / GPCC

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2022-05-31
Completion
2024-06-30

Countries

  • Poland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04683549 on ClinicalTrials.gov