HPV Serum Level and FDG PET CT in Patients With Cervical Cancer Treated With Radical Radiochemotherapy
NCT ID: NCT04683549
Last Updated: 2024-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
30 participants
INTERVENTIONAL
2020-06-15
2024-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
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.
DIAGNOSTIC
NONE
Study Groups
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One-Arm HPV serum level and FDG PET CT
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
85 Years
FEMALE
No
Sponsors
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The Greater Poland Cancer Centre
OTHER
Responsible Party
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Principal Investigators
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Ewa Burchardt, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Oncological Gynecology Clinic / GPCC
Locations
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Greater Poland Cancer Centre / Oncological Gynecology Clinic
Poznan, Greater Poland Voivodeship, Poland
Countries
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Other Identifiers
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15/06/2020/E/WCO/007
Identifier Type: -
Identifier Source: org_study_id
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