HPV After chemoRadioTherapy

NCT07493928 | Recruiting

• 2 other identifiers: 102/25GIP-26-L-04-223
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer Recurrent; Radiotherapy; Cell Free DNA; HPV

Keywords

cervical cancer; cfDNA; radiotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Rate of PCR HPV DNA negativity from a swab after CRT administration

  3 months (from the start of radiotherapy)

• Rate of HPV negativity based on detection of circulating HPV DNA fragments in peripheral blood after CRT.

  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.

  2 years

• Evaluation of the course of further treatment (especially the possibility of curability) in patients who were detected with recurrence during the study

  2 years

Study Arms (1)

Cervical cancer patients after primary (chemo)radiotherapy

Cervical cancer patients after primary (chemo)radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing primary (chemo)radiation for cervical cancer

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• General University Hospital, Prague: lead

Study Sites (1)

General Faculty Hospital in Prague

Prague, 12800, Czechia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood samples for cfDNA assessment cervical swabs

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Lukas Dostalek, MD, PhD

CONTACT

+420224967451; lukas.dostalek@vfn.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Gynecology, Obstetrics and Neonatology

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 25, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2030
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)