HPV monitoring after chemoradiotherapy for cervical cancer
Implementation of HPV Testing in Patients After Radiotherapy for Cervical Cancer
This project will test whether HPV detected on cervical swabs and in blood can find cancer recurrence in people with stage IB–IVA cervical cancer after curative chemoradiotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | General University Hospital, Prague Academic / other |
| Locations | 1 site (Prague) |
| Trial ID | NCT07493928 on ClinicalTrials.gov |
What this trial studies
HART is a prospective multicenter observational study enrolling 120 adults with FIGO stage IB–IVA cervical cancer treated with curative-intent chemoradiotherapy. HPV detection will use PCR-based testing of cervical swabs and analysis of circulating HPV tumor DNA (ctDNA) in blood collected before treatment and at 3, 12, and 24 months after completion of therapy. The primary goal is to determine the sensitivity of these molecular methods for identifying disease recurrence over a two-year follow-up period. Patients with prior pelvic radiotherapy, prior hysterectomy, HIV, or FIGO IA/IVB disease are excluded, and the study is conducted at the General Faculty Hospital in Prague.
Who should consider this trial
Good fit: Adults (≥18) with FIGO stage IB–IVA cervical cancer planned for primary curative chemoradiotherapy, who have not had prior pelvic radiotherapy or hysterectomy and do not have significant immunodeficiency, are ideal candidates.
Not a fit: Patients with FIGO IA or IVB disease, prior pelvic radiotherapy or hysterectomy, significant immunodeficiency (such as HIV), or HPV-negative tumors are unlikely to benefit from this HPV-based monitoring approach.
Why it matters
Potential benefit: If successful, HPV-based swab and blood monitoring could detect recurrences earlier than current surveillance and allow faster clinical intervention.
How similar studies have performed: Smaller studies and pilot data suggest HPV ctDNA and swab testing can signal recurrence earlier than imaging or exam, but larger prospective validation is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Prague
- General Faculty Hospital in Prague — Prague, Czechia (Recruiting)
Study contacts
- Study coordinator: Lukas Dostalek, MD, PhD
- Email: lukas.dostalek@vfn.cz
- Phone: +420224967451
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.