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NCT04683549 Clinical Trial

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

Cervical Cancer Clinical Trial

— HPV-RICCO  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04683549
Other study ID # 15/06/2020/E/WCO/007
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 15, 2020
Est. completion date June 30, 2024

Study information
Verified date December 2023
Source The Greater Poland Cancer Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 30
Est. completion date June 30, 2024
Est. primary completion date May 31, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: Age Limits: more than 18Y Histologically confirmed squamous cell carcinoma, FIGO stage IB-IVA planned for radical radiochemotherapy Eastern Cooperative Oncology Group (ECOG) performance status 0,1,2 Exclusion Criteria: Patients who have received any anticancer treatment for their cervical cancer. Eastern Cooperative Oncology Group (ECOG) performance status > 2 Other cervical cancer tumor histologies (e.g. small cell, serous) Contraindications to 18FDG PET-CT Contraindication to radiochemotherapy Known pregnancy or lactating

Study Design

Related Conditions & MeSH terms

Intervention

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: FDG PET Scan before treatment and 3 months after treatment Pre- treatment DNA from the neoplastic time preserved in the form of paraffin blocks to determine HPV status Blood sample to measure HPV DNA at time point baseline (before treatment), in the middle of treatment and at the end of definitive radiochemotherapy, [F-18] - FDG PET scan before treatment and 3 months post completion of radiochemotherapy.

Locations
Country Name City State
Poland Greater Poland Cancer Centre / Oncological Gynecology Clinic Poznan Greater Poland

Sponsors (1)
Lead Sponsor Collaborator
The Greater Poland Cancer Centre

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary local control 18 months
Primary Response to treatment 6 months
Secondary Progression-free survival 18 months
Secondary Plasma HPV DNA levels Up to 3 months
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