HPV After chemoRadioTherapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorGeneral University Hospital, Prague
About this trial
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
This trial does not accept healthy volunteersQualifiers
Patient indicated for primary RT for cervical cancer
FIGO stage IB - IVA
Signed informed consent
Age ≥ 18 years
Disqualifiers
Clinical stage FIGO IA
Clinical stage FIGO IVB
History of radiotherapy in the pelvis
Hysterectomy performed before the start of radiotherapy (adjuvant RT)
Trial population
Patients undergoing primary (chemo)radiation for cervical cancer
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 1 trial groupGroup A: Cervical cancer patients after primary (chemo)radiotherapy
Trial outcomes
Primary outcomes
1
Sensitivity of recurrence detection using Real Time PCR HPV DNA from a cervical swab in patients after (chemo)radiotherapy administered for cervical cancer
Sensitivity will be calculated as the proportion of patients who tested HPV-positive after (chemo)radiotherapy (Visit 1) among all patients who developed recurrence during the two-year follow-up.
Time frame
2 years2
Sensitivity of recurrence detection using circulating HPV DNA fragments in the peripheral blood of patients after (chemo)radiotherapy for cervical cancer
Sensitivity will be calculated as the proportion of patients with detectable circulating HPV DNA in peripheral blood after (chemo)radiotherapy (Visit 1) among all patients who developed recurrence during the two-year follow-up.
Time frame
2 yearsSecondary outcomes
1
Rate of PCR HPV DNA negativity from a swab after CRT administration
Proportion of patients with a negative HPV test by real-time PCR from a cervical swab after (chemo)radiotherapy (Visit 1) among patients who were HPV-positive before treatment (Screening).
Time frame
3 months (from the start of radiotherapy)2
Rate of HPV negativity based on detection of circulating HPV DNA fragments in peripheral blood after CRT.
Proportion of patients with an undetectable level of circulating HPV DNA in peripheral blood after completion of (chemo)radiotherapy (Visit 1) among patients in whom circulating HPV DNA was detected before treatment (Screening).
Time frame
3 months (from the start of radiotherapy)3
Comparison of the sensitivity of recurrence detection using HPV DNA PCR from cervical swabs versus detection of circulating HPV DNA fragments in peripheral blood.
The sensitivities of the two tests will be compared using receiver operating characteristic (ROC) curve analysis.
Time frame
2 years4
Evaluation of the course of further treatment (especially the possibility of curability) in patients who were detected with recurrence during the study
Proportion of patients with recurrence who underwent curative surgery (with complete resection of the recurrent tumor) among those who developed recurrence.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov