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Biomarker Analysis for Cervical Cancer

N/A
Waitlist Available
Led By Kathleen Schmeler
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women with a diagnosis of high grade intraepithelial lesion (HSIL) from a routine pap test
Women with histologically confirmed cervical, vaginal or vulvar high-grade dysplasia, invasive squamous cell carcinoma, invasive adenocarcinoma, or adenocarcinoma-in-situ (AIS). All stages and grades will be eligible
Must not have
Male patients will not be included in this study
Patients with previously documented perianal squamous cell dysplasia or invasive squamous cell carcinoma of the anus or anal canal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at how often anal cancer occurs in patients with cervical, vaginal, or vulvar cancer. Samples from patients will be studied in the lab to learn more about the human papillomavirus.

Who is the study for?
This trial is for women diagnosed with high-grade lesions or cancer of the cervix, vagina, or vulva. Participants can have any stage of squamous cell carcinoma, adenocarcinoma, or in-situ adenocarcinoma and must consent to the study. Men and those with prior anal dysplasia/cancer or HPV-related throat cancer are excluded.
What is being tested?
The study is collecting tissue samples from patients to analyze biomarkers related to human papillomavirus (HPV). It aims to understand how often anal cancer occurs in patients who have cervical, vaginal, or vulvar cancers.
What are the potential side effects?
Since this trial involves biospecimen collection rather than drug testing, typical medication side effects are not expected. However, there may be minor discomforts associated with sample collection procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with a high-grade lesion from a pap test.
Select...
I have a confirmed diagnosis of advanced cervical, vaginal, or vulvar cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not a male.
Select...
I have had squamous cell cancer or pre-cancer in my anal area before.
Select...
My throat cancer is related to HPV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Prevalence of invasive squamous cell carcinoma of the anus
Sensitivity and specificity of anal human papillomavirus (HPV) testing to diagnose anal dysplasia
Sensitivity and specificity of anal pap testing to diagnose anal dysplasia
+1 more

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: Screening (biospecimen collection)Experimental Treatment2 Interventions
Patients undergo collection of anal, cervical, vaginal, and oral samples during their scheduled pelvic exam.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,200 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,651 Total Patients Enrolled
Kathleen SchmelerPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Biospecimen Collection Clinical Trial Eligibility Overview. Trial Name: NCT02140021 — N/A
Cervical Adenocarcinoma Research Study Groups: Screening (biospecimen collection)
Cervical Adenocarcinoma Clinical Trial 2023: Biospecimen Collection Highlights & Side Effects. Trial Name: NCT02140021 — N/A
Biospecimen Collection 2023 Treatment Timeline for Medical Study. Trial Name: NCT02140021 — N/A
~50 spots leftby Apr 2026
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