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FDG-PET for Cervical Cancer (HPVDNA02 Trial)
N/A
Recruiting
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix, FIGO stage IB-IVA
Age ≥ 18 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
HPVDNA02 Trial Summary
This trial will test how well the FDG-PET scan and blood tests for HPV can detect leftover cervical cancer cells after treatment.
Who is the study for?
This trial is for adults over 18 with cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous) at stages IB-IVA who are about to start standard treatment with radiotherapy and cisplatin chemotherapy. It's not open to those who've had previous cancer treatments, are pregnant or breastfeeding, have conditions that rule out PET-CT scans or radiotherapy like severe Crohn's disease, non-reversible kidney issues, other invasive cancers within the last 5 years (except certain skin cancers), or evidence of distant metastases.Check my eligibility
What is being tested?
The study tests how well an FDG-PET Scan and blood tests for HPV can detect remaining cervical cancer cells after standard treatment. The FDG-PET Scan is a special imaging test that shows active areas of cancer by tracking a sugar molecule in the body. Blood tests will check for HPV presence as an indicator of treatment effectiveness.See study design
What are the potential side effects?
Since this study involves diagnostic procedures rather than new treatments, side effects may include discomfort from the PET-CT scan process such as reactions to contrast materials used during imaging. There might also be typical risks associated with drawing blood.
HPVDNA02 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cervical cancer is confirmed and is at stage IB-IVA.
Select...
I am 18 years old or older.
Select...
I am scheduled for intense radiotherapy and chemotherapy with cisplatin.
HPVDNA02 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival rate
Secondary outcome measures
Plasma HPV DNA levels
HPVDNA02 Trial Design
1Treatment groups
Experimental Treatment
Group I: FDG PET ScanExperimental Treatment1 Intervention
[F-18] - FDG PET Scan and blood sample to measure HPV DNA
Find a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreOTHER
656 Previous Clinical Trials
1,551,244 Total Patients Enrolled
University Health Network, TorontoLead Sponsor
1,474 Previous Clinical Trials
484,978 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cervical cancer is confirmed and is at stage IB-IVA.My cancer has spread to distant parts of my body, but it may include certain lymph nodes if they can be targeted by radiation.I have had cancer before, but it was either skin cancer or treated and clear for over 5 years.I am 18 years old or older.I cannot undergo chemotherapy due to a health issue like kidney failure.My cervical cancer is not the usual type.I have received treatment for my cervical cancer.I cannot undergo radiotherapy due to a severe condition like Crohn's disease.I am scheduled for intense radiotherapy and chemotherapy with cisplatin.
Research Study Groups:
This trial has the following groups:- Group 1: FDG PET Scan
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are accepted for this investigation?
"Affirmative, based on information presented on clinicaltrials.gov this experiment is recruiting patients at the present time. It was initially circulated on April 23rd 2019 and last modified October 4th 2021; 64 subjects are necessary to be sourced from 1 medical site."
Answered by AI
Are applicants currently being accepted for participation in this research project?
"The clinical trial is open to applicants, as evidenced by the information on clinicaltrials.gov. The initial posting was made April 23rd 2019 and it underwent its most recent update October 4th 2021."
Answered by AI
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