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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
Must not have
Patients who have had a hysterectomy
History of endometrial hyperplasia or cancer of the endometrium, vagina, or cervix
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
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.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a hysterectomy.
Select...
I have had endometrial, vaginal, or cervical cancer or pre-cancer.
Select...
I have received or am receiving radiation or chemotherapy for vaginal or cervical cancer.
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
13,748 Previous Clinical Trials
40,958,524 Total Patients Enrolled
GOG FoundationLead Sponsor
45 Previous Clinical Trials
16,557 Total Patients Enrolled
Gynecologic Oncology GroupLead Sponsor
250 Previous Clinical Trials
70,509 Total Patients Enrolled
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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.
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