Clinical trial NCT04683549: HPV Serum Level and FDG PET CT in Patients With Cervical Cancer Treated With Radical Radiochemotherapy
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cervical Cancer
Keywords: locally advanced cervical cancer
HPV
radiochemotherapy
FDG PET CT
Lead sponsor: The Greater Poland Cancer Centre
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: local control
timeFrame: 18 months
measure: Response to treatment
timeFrame: 6 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: 18 months
measure: Plasma HPV DNA levels
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Greater Poland Cancer Centre / Oncological Gynecology Clinic
state: Greater Poland
Study officials:
affiliation: Oncological Gynecology Clinic / GPCC
name: Ewa Burchardt, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: