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Recruiting NCT07493928

HPV After chemoRadioTherapy

— Observational Cervical Cancer Recurrent Radiotherapy Cell Free DNA HPV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cervical Cancer Recurrent, Radiotherapy, Cell Free DNA, HPV. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Implementation of HPV Testing in Patients After Radiotherapy for Cervical Cancer

Overview

The HART (HPV After chemoRadiotherapy) study is a prospective multicenter observational trial designed to evaluate the clinical utility of HPV testing in the follow-up of patients treated with definitive chemoradiotherapy (CRT) for cervical cancer. Current surveillance after CRT relies mainly on clinical examination and imaging, while the role of HPV-based molecular monitoring remains insufficiently defined. The study plans to enroll 120 patients with FIGO stage IB-IVA cervical cancer treated with primary radiotherapy with curative intent. HPV detection will be performed using two complementary approaches: PCR-based detection of HPV DNA from a cervical swab and analysis of circulating HPV tumor DNA (ctDNA) in peripheral blood. Samples will be collected before treatment and during follow-up at 3, 12, and 24 months after completion of CRT. The primary objective is to determine the sensitivity of these methods for detecting disease recurrence during a two-year follow-up period. Secondary objectives include evaluation of HPV clearance after treatment, comparison of HPV genotypes before and after therapy in cases of persistence, and comparison of the diagnostic performance of cervical HPV testing and ctDNA detection. The study aims to generate evidence supporting the integration of HPV-based molecular monitoring into routine follow-up, potentially enabling earlier detection of recurrence and more individualized surveillance strategies for patients after CRT for cervical cancer.

Primary outcome measures

  • Sensitivity of recurrence detection using Real Time PCR HPV DNA from a cervical swab in patients after (chemo)radiotherapy administered for cervical cancer [Time frame: 2 years]
  • Sensitivity of recurrence detection using circulating HPV DNA fragments in the peripheral blood of patients after (chemo)radiotherapy for cervical cancer [Time frame: 2 years]
Secondary outcome measures (4)
  • Rate of PCR HPV DNA negativity from a swab after CRT administration [Time frame: 3 months (from the start of radiotherapy)]
  • Rate of HPV negativity based on detection of circulating HPV DNA fragments in peripheral blood after CRT. [Time frame: 3 months (from the start of radiotherapy)]
  • Comparison of the sensitivity of recurrence detection using HPV DNA PCR from cervical swabs versus detection of circulating HPV DNA fragments in peripheral blood. [Time frame: 2 years]
  • Evaluation of the course of further treatment (especially the possibility of curability) in patients who were detected with recurrence during the study [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • Patient indicated for primary RT for cervical cancer
  • FIGO stage IB - IVA
  • Signed informed consent
  • Age ≥ 18 years
  • Administration of RT with curative intent

Exclusion criteria

  • Clinical stage FIGO IA
  • Clinical stage FIGO IVB
  • History of radiotherapy in the pelvis
  • Hysterectomy performed before the start of radiotherapy (adjuvant RT)
  • History of HPV-associated malignancy in personal history
  • HIV or other significant immunodeficiency

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Czechia · 1 center
  • General Faculty Hospital in Prague — Prague

Identifiers

NCT: NCT07493928 · 102/25 · GIP-26-L-04-223

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗