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Diagnostic Test

Screening Tests for Anal Cancer (SWAN Trial)

N/A
Recruiting
Led By Elizabeth Chiao, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women with a history of pathologically proven high-grade genital HPV-associated neoplastic disease (cervical intraepithelial neoplasia 2+, vulvar intraepithelial neoplasia 2+, or vaginal intraepithelial neoplasia 2+, or history of non-metastatic cervical, vaginal or vulvar cancer)
Aged 35 years and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trialtests ways to detect early signs of anal cancer in HIV-negative women with a history of genital cancer.

Who is the study for?
This trial is for women under 45 years old who have had high-grade HPV-related diseases or non-metastatic cancers of the cervix, vagina, or vulva. They must be HIV-negative and treated within Mount Sinai Health System or Harris Health System in Houston. Participants need to understand English or Spanish.
What is being tested?
The study is evaluating diagnostic tests used to screen for anal cancer precursors in women with a history of lower genital tract neoplasias and cancers but who do not have HIV.
What are the potential side effects?
Since this trial involves diagnostic screening rather than medication, side effects are minimal but may include discomfort during testing procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had a high-grade HPV-related disease or non-spreading cancer in my genital area.
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I am 35 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sensitivity and specificity of anal cytology
Secondary study objectives
Concordance of self- and clinician-collected PCR testing
Incidence of aHSIL at follow-up
Incidence of hrHPV, by type
+6 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: Women With Prior HPV for Anal NeoplasiaExperimental Treatment1 Intervention
Standard of care anal cancer screening with anal cytology, HPV testing and high resolution anoscopy.

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaOTHER
979 Previous Clinical Trials
7,400,694 Total Patients Enrolled
M.D. Anderson Cancer CenterOTHER
3,074 Previous Clinical Trials
1,803,047 Total Patients Enrolled
The University of Texas Health Science Center, HoustonOTHER
957 Previous Clinical Trials
347,557 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiLead Sponsor
914 Previous Clinical Trials
572,601 Total Patients Enrolled
Baylor College of MedicineOTHER
1,028 Previous Clinical Trials
6,029,862 Total Patients Enrolled
Elizabeth Chiao, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Ashish Deshmukh, PhDPrincipal InvestigatorMedical University of South Carolina
Keith Sigel, MD, PhD, MPHPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Media Library

Diagnostic tests for anal cancer screening (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT05217940 — N/A
Lower Genital Tract Neoplasias Research Study Groups: Women With Prior HPV for Anal Neoplasia
Lower Genital Tract Neoplasias Clinical Trial 2023: Diagnostic tests for anal cancer screening Highlights & Side Effects. Trial Name: NCT05217940 — N/A
Diagnostic tests for anal cancer screening (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05217940 — N/A
~120 spots leftby Nov 2026
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