Trial Parameters
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Brief 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.
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