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Biomarker Analysis for Cervical Cancer Diagnosis

Phase 1
Waitlist Available
Led By Shu-Yuan liao
Research Sponsored by Gynecologic Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a cytologic diagnosis of AGC (AGC, atypical endocervical cells [AEC], atypical endometrial cells [AEmC]) or a cytologic/histologic diagnosis of AIS documented within the last 6 months who can wait at least one week after the AGC or AIS diagnosis to have an LBC specimen (i.e., ThinPrep) collected and then receive any other intervention; acceptable time frame range is 4 days prior to registration to 7 days after registration
Patients with positive HPV results who are willing to undergo a complete histologic examination of the uterus and cervix, including the cervical transformation zone, within 6 months of the AGC or AIS diagnosis (histologic examination includes a loop electrosurgical excision procedure [LEEP], loop excision of the transformation zone [LETZ], excisional cone biopsy, or hysterectomy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
No Placebo-Only Group

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was diagnosed with abnormal glandular cells or AIS in the last 6 months and can wait for a specific test.
Select...
I have HPV and agree to a detailed exam of my uterus and cervix within 6 months after my AGC or AIS diagnosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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?

Gynecologic Oncology GroupLead Sponsor
250 Previous Clinical Trials
70,049 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,565 Previous Clinical Trials
41,222,923 Total Patients Enrolled
Shu-Yuan liaoPrincipal InvestigatorGynecologic Oncology Group

Media Library

Ancillary-Correlative (biomarkers in cervical cancer) Clinical Trial Eligibility Overview. Trial Name: NCT00892866 — Phase 1
Cervical Cancer Research Study Groups: Ancillary-Correlative (biomarkers in cervical cancer)
Cervical Cancer Clinical Trial 2023: Ancillary-Correlative (biomarkers in cervical cancer) Highlights & Side Effects. Trial Name: NCT00892866 — Phase 1
Ancillary-Correlative (biomarkers in cervical cancer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00892866 — Phase 1

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
~67 spots leftby May 2025