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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

No Placebo-Only Group

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.

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.

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:

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I have had a hysterectomy.

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I have had endometrial, vaginal, or cervical cancer or pre-cancer.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Biomarker expression in patients from Japan

Biomarker expression in patients from Korea

Biomarker expression in patients from North America

Secondary study objectives

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 study objectives

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.

0 / 3Eligibility criteria met