Biomarker Analysis for Cervical Cancer Diagnosis

Recruiting in Palo Alto (17 mi)

+167 other locations

Overseen byShu-Yuan liao

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: GOG Foundation

No Placebo Group

Trial Summary

What is the purpose of this trial?

This research trial studies carbonic anhydrase 9 (CA-IX), p16, proliferative markers, and human papilloma virus (HPV) in diagnosing cervical lesions in patients with abnormal cervical cells. Studying biomarkers in abnormal cervical cells may improve the ability to find cervical lesions and plan effective treatment.

Research Team

Shu-Yuan liao

Principal Investigator

Gynecologic Oncology Group

Eligibility Criteria

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.

Inclusion Criteria

I was diagnosed with abnormal glandular cells or AIS in the last 6 months and can wait for a specific test.

Patients must have signed an approved informed consent and authorization permitting release of personal health information

I have HPV and agree to a detailed exam of my uterus and cervix within 6 months after my AGC or AIS diagnosis.

Exclusion Criteria

Patients who are pregnant and thought to be at risk for excessive bleeding or preterm labor if a cone biopsy is performed

I have had a hysterectomy.

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

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Treatment Details

Interventions

Cytology Specimen Collection Procedure (Procedure)
Laboratory Biomarker Analysis (Other)

Trial OverviewThe 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.

Participant Groups

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.