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Clinical Trial NCT07493928 (HART) for Cervical Cancer Recurrent, Radiotherapy, Cell Free DNA, HPV is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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HPV After chemoRadioTherapy (HART) 120 Observational
Clinical Trial NCT07493928 (HART) is an observational study for Cervical Cancer Recurrent, Radiotherapy, Cell Free DNA, HPV that is recruiting. It started on 1 February 2026 with plans to enroll 120 participants. Led by General University Hospital, Prague, it is expected to complete by 1 February 2030. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
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 stud...Show More
Official Title
Implementation of HPV Testing in Patients After Radiotherapy for Cervical Cancer
Conditions
Cervical Cancer RecurrentRadiotherapyCell Free DNAHPVOther Study IDs
- HART
- 102/25
- GIP-26-L-04-223 (Other Grant/Funding Number) (General Faculty Hospital, Prague)
NCT ID Number
Start Date (Actual)
2026-02-01
Last Update Posted
2026-03-25
Completion Date (Estimated)
2030-02-01
Enrollment (Estimated)
120
Study Type
Observational
Status
Recruiting
Keywords
cervical cancer
cfDNA
radiotherapy
cfDNA
radiotherapy
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Cervical cancer patients after primary (chemo)radiotherapy Cervical cancer patients after primary (chemo)radiotherapy | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 2 years |
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. | 2 years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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). | 3 months (from the start of radiotherapy) |
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). | 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. | The sensitivities of the two tests will be compared using receiver operating characteristic (ROC) curve analysis. | 2 years |
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. | 2 years |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
- Patient indicated for primary RT for cervical cancer
- FIGO stage IB - IVA
- Signed informed consent
- Age ≥ 18 years
- Administration of RT with curative intent
- 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
General University Hospital, PragueStudy Responsible Party
David Cibula, Principal Investigator, Head of the Department of Gynecology, Obstetrics and Neonatology, General University Hospital, Prague
Study Central Contact
Contact: Lukas Dostalek, MD, PhD, +420224967451, [email protected]
1 Study Locations in 1 Countries
General Faculty Hospital in Prague, Prague, 12800, Czechia
Lukas Dostalek, MD PhD, Contact, +420224967451, [email protected]
Recruiting