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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-02553 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2014-0021 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies the prevalence of anal dysplasia and anal cancer in patients with cervical, vaginal, and vulvar dysplasia and cancer. Studying samples collected from patients in the laboratory may help doctors learn more about the human papillomavirus and how often anal cancer occurs in patients with cervix, vagina, or vulvar cancer.
PRIMARY OBJECTIVES:
I. To estimate the prevalence of invasive squamous cell carcinoma of the anus in women with high-grade dysplasia or carcinoma of the cervix, vagina or vulva.
SECONDARY OBJECTIVES:
I. To estimate the prevalence of anal dysplasia in women with high-grade dysplasia or carcinoma of the cervix, vagina or vulva.
EXPLORATORY OBJECTIVES:
I. To estimate the clinical performance (sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios) of anal pap testing to diagnose anal dysplasia in women with high-grade dysplasia or carcinoma of the cervix, vagina or vulva.
II. To estimate the clinical performance (sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios) of anal high-risk human papillomavirus (HPV) testing to diagnose anal dysplasia in women with high-grade dysplasia or carcinoma of the cervix, vagina or vulva.
III. To estimate the clinical performance (sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios) of anal pap testing and HPV testing (anal "cotesting") to diagnose anal dysplasia in women with high-grade dysplasia or carcinoma of the cervix, vagina or vulva.
IV. To determine associations between gut and cervical microbiomes and anal dysplasia/carcinoma in women with high-grade dysplasia or carcinoma of the cervix, vagina, or vulva.
V. To estimate the prevalence of oral HPV infection in women with high-grade dysplasia or carcinoma of the cervix, vagina or vulva.
VI. To compare a new HPV point of care test developed by Rice University with current standard HPV testing.
OUTLINE:
Patients undergo collection of anal, cervical, vaginal, and oral samples during their scheduled pelvic exam.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening (biospecimen collection) | Experimental | Patients undergo collection of anal, cervical, vaginal, and oral samples during their scheduled pelvic exam. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo anal, cervical, vaginal, and oral sample collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of invasive squamous cell carcinoma of the anus | Will estimate the prevalence of invasive squamous cell carcinoma of the anus in women with 95% confidence intervals. | Up to 5 years |
| Sensitivity and specificity of anal pap testing to diagnose anal dysplasia | Will use the results of anoscopy as the true state of the patient and will estimate with 95% confidence intervals. | Up to 5 years |
| Sensitivity and specificity of anal human papillomavirus (HPV) testing to diagnose anal dysplasia | Will use the results of anoscopy as the true state of the patient and will estimate with 95% confidence intervals. | Up to 5 years |
| Sensitivity and specificity of the combination of anal pap testing + anal HPV testing to diagnose anal dysplasia | Will use the results of anoscopy as the true state of the patient and will estimate with 95% confidence intervals. | Up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Schmeler | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyndon Baines Johnson General Hospital | Houston | Texas | 77026-1967 | United States | ||
| M D Anderson Cancer Center |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 9, 2019 | Jul 9, 2025 |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Houston |
| Texas |
| 77030 |
| United States |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| D002583 | Uterine Cervical Neoplasms |
| D014625 | Vaginal Neoplasms |
| D014846 | Vulvar Neoplasms |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D014623 | Vaginal Diseases |
| D014845 | Vulvar Diseases |
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