NCT04683549

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

January 8, 2024

Status Verified

December 1, 2023

Enrollment Period

2 years

First QC Date

December 21, 2020

Last Update Submit

January 4, 2024

Conditions

Cervical Cancer

Keywords

locally advanced cervical cancerHPVradiochemotherapyFDG PET CT

Outcome Measures

Primary Outcomes (2)

  • local control

    18 months

  • Response to treatment

    6 months

Secondary Outcomes (2)

  • Progression-free survival

    18 months

  • Plasma HPV DNA levels

    Up to 3 months

Study Arms (1)

One-Arm HPV serum level and FDG PET CT

OTHER

HPV serum level and FDG PET CT in patients with cervical cancer treated with radical radiochemotherapy

Diagnostic Test: HPV serum level and FDG PET CT in patients with cervical cancer treated with radical radiochemotherapy

Interventions

HPV serum level and FDG PET CT in patients with cervical cancer treated with radical radiochemotherapyDIAGNOSTIC_TEST

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.

One-Arm HPV serum level and FDG PET CT

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Greater Poland Cancer Centre / Oncological Gynecology Clinic

Poznan, Greater Poland Voivodeship, 61-866, Poland

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Ewa Burchardt, PhD, MD

    Oncological Gynecology Clinic / GPCC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2020

First Posted

December 24, 2020

Study Start

June 15, 2020

Primary Completion

May 31, 2022

Study Completion

June 30, 2024

Last Updated

January 8, 2024

Record last verified: 2023-12

Locations

PL(1)