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HPV After chemoRadioTherapy

NCT07493928 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-03-25

No results posted yet for this study

Summary

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.

Conditions

  • Cervical Cancer Recurrent
  • Radiotherapy
  • Cell Free DNA
  • HPV

Sponsors & Collaborators

  • General University Hospital, Prague

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2028-02-01
Completion
2030-02-01

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

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 NCT07493928 on ClinicalTrials.gov