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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

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 2
~1730

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,786,807 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,080 Total Patients Enrolled
Kathleen SchmelerPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Biospecimen Collection Clinical Trial Eligibility Overview. Trial Name: NCT02140021 — N/A
Vulvar Cancer Research Study Groups: Screening (biospecimen collection)
Vulvar Cancer 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Biospecimen Collection and Testing for the Prevalence of Anal Dysplasia and Anal Cancer in Patients With Cervical, Vaginal and Vulvar Dysplasia and Cancer
2014. "Biospecimen Collection and Testing for the Prevalence of Anal Dysplasia and Anal Cancer in Patients With Cervical, Vaginal and Vulvar Dysplasia and Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02140021.
All > Anal Cancer > Cervical Cancer
~0 spots leftby Apr 2024
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