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| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
| Medical University of South Carolina | OTHER |
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The goal of this single arm trial is to prospectively evaluate screening methods for anal cancer precursors in HIV uninfected women with a history of lower genital tract neoplasias and cancers.
This single arm trial will enroll 300 HIV uninfected women with a history of genital neoplasia (ie., cervical intraepithelial neoplasia grade 2-3, vaginal intraepithelial neoplasia grade 2-3 or vulvar intraepithelial neoplasia grade 2-3) or early stage cervical or vulvar cancer to evaluate the test characteristics of anal cancer screening tests (cytology, HPV testing and high resolution anoscopy) and determine the prevalence and incidence of anal high-grade squamous intraepithelial lesions in this population. Participants will undergo evaluation at baseline and then at 12 and 24 months. The investigators will also measure the acceptability of anal cancer screening in this previously unstudied group. The trial is expected to run from 2021-2027.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women With Prior HPV for Anal Neoplasia | Experimental | Standard of care anal cancer screening with anal cytology, HPV testing and high resolution anoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic tests for anal cancer screening | Diagnostic Test | The initial screening interventions will include the collection of (1) anal cytology; (2) self-collected HPV testing specimens (by subjects); (3) a clinician collected HPV specimen. A digital rectal exam will also be done on all patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of anal cytology | Test sensitivity and specificity | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Concordance of self- and clinician-collected PCR testing | Proportionate concordance of high-risk HPV testing | baseline |
| Prevalence of hrHPV types at baseline | Proportion of subjects with high-risk HPV and subtype proportions |
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Inclusion Criteria:
Exclusion Criteria:
• prior history or high resolution anoscopy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniela Solis | Contact | 305-775-2140 | daniela.solis@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| Keith Sigel, MD, PhD, MPH | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Elizabeth Chiao, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
All of the individual participant data collected during the trial, after deidentification.
Beginning 3 months and ending 5 years following article publication.
Researchers who provide a methodologically sound proposal. Any purpose. Email principal investigator: keith.sigel@mssm.edu
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| ID | Term |
|---|---|
| D001005 | Anus Neoplasms |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
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| ID | Term |
|---|---|
| D003955 | Diagnostic Tests, Routine |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| Baseline |
| hrHPV with Cobas PCR testing (self-collected) | Presence of high-risk HPV subtype | Baseline |
| hrHPV with Cobas PCR testing (self-collected) | Presence of high-risk HPV subtype | 12 months |
| hrHPV with Cobas PCR testing (self-collected) | Presence of high-risk HPV subtype | 24 months |
| hrHPV with Cobas PCR testing (clinician-collected) | Presence of high-risk HPV subtype | Baseline |
| hrHPV with Cobas PCR testing (clinician-collected) | Presence of high-risk HPV subtype | 12 months |
| hrHPV with Cobas PCR testing (clinician-collected) | Presence of high-risk HPV subtype | 24 months |
| Prevalence of aHSIL at baseline | Proportion of subjects with aHSIL | Baseline |
| Incidence of aHSIL at follow-up | Proportion of subjects with new aHSIL during follow-up period | 24 months |
| Screening Experience Survey | Survey measures anal cancer screening test acceptability. Each item is scored 0-3, with higher score indicting more acceptability. 0-3. There is no total scale. Each question is scored separately and the overall results are used qualitatively. | Baseline |
| Incidence of hrHPV, by type | Proportion of subjects with new hrHPV infection | 12 months |
| Incidence of hrHPV, by type | Proportion of subjects with new hrHPV infection | 24 months |
| Proportion of subjects with new hrHPV infection | Proportion of subjects with prevalent hrHPV without measurable hrHPV at follow-up | 12 months |
| Proportion of subjects with new hrHPV infection | Proportion of subjects with prevalent hrHPV without measurable hrHPV at follow-up | 24 months |
| Ashish Deshmukh, PhD |
| Medical University of South Carolina |
| Principal Investigator |
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
|
| University of Texas M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
|
| D004067 |
| Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |