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Biomarker Testing with Standard Treatment for Cervical Cancer
N/A
Recruiting
Led By Denise Fabian, MD
Research Sponsored by Denise Fabian
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months posttherapy
Awards & highlights
Study Summary
This trialtests biomarkers of uterine cervix cancer in women receiving radiochemotherapy and brachytherapy. Blood samples are used to detect cancer markers.
Who is the study for?
This trial is for women with untreated cervical cancer stages IB3 (>4cm), II, III, or IVA. It's not suitable for those who've had other invasive cancers in the last three years (except certain skin cancers and in situ cervical carcinoma) or prior pelvic radiotherapy that could harm normal tissue.Check my eligibility
What is being tested?
The study tests molecular biomarkers in women undergoing standard radiochemotherapy followed by brachytherapy for uterine cervix cancer. Researchers will analyze blood samples to detect specific DNA and tumor cells.See study design
What are the potential side effects?
Since patients receive standard treatments, side effects may include fatigue, nausea, hair loss from chemotherapy; skin irritation and discomfort from radiation; and potential bleeding or infection from sample collection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months posttherapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months posttherapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Biomarker
Side effects data
From 2014 Phase 4 trial • 82 Patients • NCT0183537912%
Osteomyelitis
5%
Cellulitis
2%
Anaemia
2%
Deep vein thrombosis
2%
Lower GI hermorrhage
2%
GERD
2%
Transient ischemic attack (TIA)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard
Oasis
Trial Design
1Treatment groups
Experimental Treatment
Group I: Radiochemotherapy followed by brachytherapyExperimental Treatment1 Intervention
Standard daily radiotherapy plus weekly cisplatin followed by brachytherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard
2013
Completed Phase 4
~5340
Find a Location
Who is running the clinical trial?
UK Radiopharma AllianceUNKNOWN
Denise FabianLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Charles KunosLead Sponsor
1 Previous Clinical Trials
2 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer in the last 3 years, except for skin cancer or cervical pre-cancer.I have another active cancer besides the one being treated.My cervical cancer is at a stage that cannot be cured by surgery alone.I have had pelvic radiotherapy that might affect my treatment now.
Research Study Groups:
This trial has the following groups:- Group 1: Radiochemotherapy followed by brachytherapy
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.
Are there any vacancies for participants in this medical trial?
"Clinicaltrials.gov information suggests that this medical trial is actively enrolling participants, with a first posting date of March 1st 2023 and most recent update on April 1st 2023."
Answered by AI
To what extent is the trial participant pool expanding?
"Affirmative, the information on clinicaltrials.gov verifies that this study is currently seeking volunteers. This experiment was initially posted on March 1st 2023 and has been recently revised as of April 1st 2023. 30 participants are being recruited from a single medical centre."
Answered by AI
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