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HPV Testing During Follow-Up After Radiotherapy for Cervical Cancer

Studies HPV tests for spotting cervical cancer recurrence after chemoradiotherapy.

Plain-language title generated from the registry record
Registry title: HPV After chemoRadioTherapy

Key facts

Where
Prague, CzechiaSee the site

Where in Czechia

  • General Faculty Hospital in PraguePrague, CzechiaTaking people

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Trial details

Who runs it
General University Hospital, Prague
Trial code
NCT07493928
Record updated
25 March 2026
Original description
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.Read full original descriptionShow less

Implementation of HPV Testing in Patients After Radiotherapy for Cervical Cancer

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.

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

ClinicalTrials.gov NCT07493928