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Biomarker Analysis for Cervical Cancer Diagnosis
N/A
Waitlist Available
Led By Shu-Yuan liao
Research Sponsored by GOG Foundation
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 baseline
Awards & highlights
Study Summary
This trialstudies biomarkers to better diagnose cervical lesions, improving treatment plans for abnormal cervical cells.
Who is the study for?
This trial is for patients with abnormal cervical cells, diagnosed within the last 6 months, who have not had a hysterectomy or treatment for vaginal/cervical cancer. They must consent to personal health information release and be willing to undergo a full examination of the uterus and cervix if HPV positive.Check my eligibility
What is being tested?
The study is testing how well certain biomarkers like CA-IX, p16, proliferative markers, and HPV can diagnose cervical lesions. It involves collecting cervical cell samples (LBC specimen) and analyzing them in a lab.See study design
What are the potential side effects?
Since this trial involves diagnostic procedures rather than drug treatments, side effects are minimal but may include discomfort from sample collection and potential risks associated with complete histologic examinations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Biomarker expression in patients from Japan
Biomarker expression in patients from Korea
Biomarker expression in patients from North America
Secondary outcome measures
Effect of patient age on the accuracy of diagnosis based on CA-IX, HPV, p16, Ki-67, and/or MCM2 expression in the Korean and Japanese populations
Effect of patient age on the accuracy of diagnosis based on CA-IX, HPV, p16, Ki-67, and/or MCM2 expression in the North American population
Other outcome measures
Biomarker expression, loss of heterozygosity (LOH), chromosome gains, and chromosome losses in tissue from the highest grade or most abnormal lesions in women with AGC
CA-IX expression, combined p16 and Ki67 expression, and MCM2 expression in LBC specimens
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ancillary-Correlative (biomarkers in cervical cancer)Experimental Treatment2 Interventions
Patients undergo liquid-based cytology specimen sample collection for analysis of CA-IX, p16, Ki-67, and MCM2 expression via IHC and for the presence of high risk HPV DNA and HPV genotyping.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,276 Total Patients Enrolled
GOG FoundationLead Sponsor
41 Previous Clinical Trials
15,264 Total Patients Enrolled
Gynecologic Oncology GroupLead Sponsor
250 Previous Clinical Trials
70,049 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with abnormal glandular cells or AIS in the last 6 months and can wait for a specific test.I have HPV and agree to a detailed exam of my uterus and cervix within 6 months after my AGC or AIS diagnosis.I have had a hysterectomy.I have had endometrial, vaginal, or cervical cancer or pre-cancer.I have received or am receiving radiation or chemotherapy for vaginal or cervical cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Ancillary-Correlative (biomarkers in cervical cancer)
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 health facilities are participating in this clinical investigation?
"Patients in this trial are being recruited from Grant Medical Center (Columbus, Ohio), Truman Medical Centers (Kansas City, Missouri) and Grady Memorial Hospital (Delaware, Oklahoma). Additionally there are 70 other locations participating."
Answered by AI
Is this experiment actively seeking volunteers?
"Clinicaltrials.gov states that this research project is no longer actively looking for participants due to being first posted on February 9th, 2009 and last updated October 27th 2022. However, there are currently 205 other studies in need of patient volunteers."
Answered by AI
Has this treatment been granted authorization from the FDA?
"The safety of this treatment has been approximated to be a 1, as it is currently at the initial stage of testing and there is little evidence that suggests its efficacy or security."
Answered by AI
Who else is applying?
What site did they apply to?
Banner University Medical Center - Tucson
What portion of applicants met pre-screening criteria?
Did not meet criteria
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