HPV After chemoRadioTherapy

Официальное название

Implementation of HPV Testing in Patients After Radiotherapy for Cervical Cancer

Обзор

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.

Первичные конечные точки

• Sensitivity of recurrence detection using Real Time PCR HPV DNA from a cervical swab in patients after (chemo)radiotherapy administered for cervical cancer [Срок оценки: 2 years]
• Sensitivity of recurrence detection using circulating HPV DNA fragments in the peripheral blood of patients after (chemo)radiotherapy for cervical cancer [Срок оценки: 2 years]

Вторичные конечные точки (4)

• Rate of PCR HPV DNA negativity from a swab after CRT administration [Срок оценки: 3 months (from the start of radiotherapy)]
• Rate of HPV negativity based on detection of circulating HPV DNA fragments in peripheral blood after CRT. [Срок оценки: 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. [Срок оценки: 2 years]
• Evaluation of the course of further treatment (especially the possibility of curability) in patients who were detected with recurrence during the study [Срок оценки: 2 years]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Чехия · 1 центр

• General Faculty Hospital in Prague — Prague

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗