NCT04683549

HPV Serum Level and FDG PET CT in Patients With Cervical Cancer Treated With Radical Radiochemotherapy

HPV Serum Level and FDG PET CT in Patients With Cervical Cancer Treated With Radical Radiochemotherapy (HPV-RICCO - HPV Relation in Cervical Cancer Outcomes)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: The Greater Poland Cancer Centre · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of the study is to describe changes in plasma HPV DNA levels in patients with locally advanced cervical cancer during radical radiochemotherapy (CRT) and to correlate changes with response to treatment. Monitoring of the response to treatment will also be assessed in FDG PET CT imaging.

Detailed description

Ninety-five per cent of cervical cancer cases are caused by persistent infections with carcinogenic HPVs. Locally advanced stage IB2 to IVA cervical cancers are treated with definitive chemoradiation therapy (CRT). Despite known clinical prognostic factors of poor treatment outcome such as advanced stage and positive nodal status, we still don't know predictors of relapse. HPV status will be assessed in the neoplastic tissue and DNA from the blood serum of patients with cervical cancer will be isolated and analyzed by real-time PCR. Plasma HPV DNA would identify patients with residual disease after CRT due to persistent detectable HPV. This would earlier detect high risk patients who would benefit from adjuvant therapy. While metabolic response in post - therapy FDG PET CT is predictive of survival, there is usually 3 months waiting period time needed to perform this imaging. This pilot study will provide preliminary estimates of the correlation between plasma HPV DNA level, PET finding and clinical outcome in polish cervical cancer patients.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	HPV serum level and FDG PET CT in patients with cervical cancer treated with radical radiochemotherapy	Locally advanced non-operable newly diagnosed FIGO stage IB-IVA cervical cancer patients planned for definitive radiochemotherapy will be accrued to study and will have: 1. FDG PET Scan before treatment and 3 months after treatment 2. Pre- treatment DNA from the neoplastic time preserved in the form of paraffin blocks to determine HPV status 3. Blood sample to measure HPV DNA at time point baseline (before treatment), in the middle of treatment and at the end of definitive radiochemotherapy, 4. \[F-18\] - FDG PET scan before treatment and 3 months post completion of radiochemotherapy.

Timeline

• Start date: 2020-06-15
• Primary completion: 2022-05-31
• Completion: 2024-06-30
• First posted: 2020-12-24
• Last updated: 2024-01-08

Locations

1 site across 1 country: Poland