HPV After chemoRadioTherapy (HART)

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.

Study Overview

• Status: Recruiting
• Conditions: HPV; Radiotherapy; Cervical Cancer Recurrent; Cell Free DNA

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Lukas Dostalek, MD, PhD; Phone Number: +420224967451; Email: lukas.dostalek@vfn.cz

Study Locations

• Czechia
  • Prague, Czechia, 12800
    • Recruiting
    • General Faculty Hospital in Prague
    • Contact: Lukas Dostalek, MD PhD; Phone Number: +420224967451; Email: lukas.dostalek@vfn.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing primary (chemo)radiation for cervical cancer

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cervical cancer patients after primary (chemo)radiotherapy

What is the study measuring?

Primary 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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: General University Hospital, Prague

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: March 8, 2026
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: radiotherapy; cfDNA; cervical cancer
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms
• Other Study ID Numbers: 102/25; GIP-26-L-04-223 (Other Grant/Funding Number: General Faculty Hospital, Prague)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No