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| ID | Type | Description | Link |
|---|---|---|---|
| GIP-26-L-04-223 | Other Grant/Funding Number | General Faculty Hospital, Prague |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical cancer patients after primary (chemo)radiotherapy | Cervical cancer patients after primary (chemo)radiotherapy |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Women
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Patients undergoing primary (chemo)radiation for cervical cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lukas Dostalek, MD, PhD | Contact | +420224967451 | lukas.dostalek@vfn.cz |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Faculty Hospital in Prague | Recruiting | Prague | 12800 | Czechia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 10, 2025 | Mar 11, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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blood samples for cfDNA assessment cervical swabs
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 |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |