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Biospecimen Collection and Testing for the Prevalence of Anal Dysplasia and Anal Cancer in Patients With Cervical, Vaginal and Vulvar Dysplasia and Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02140021
Recruitment Status : Recruiting
First Posted : May 16, 2014
Last Update Posted : December 23, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE May 14, 2014
First Posted Date  ICMJE May 16, 2014
Last Update Posted Date December 23, 2019
Actual Study Start Date  ICMJE October 27, 2014
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2018)
  • Prevalence of invasive squamous cell carcinoma of the anus [ Time Frame: Up to 5 years ]
    Will estimate the prevalence of invasive squamous cell carcinoma of the anus in women with 95% confidence intervals.
  • Sensitivity and specificity of anal pap testing to diagnose anal dysplasia [ Time Frame: Up to 5 years ]
    Will use the results of anoscopy as the true state of the patient and will estimate with 95% confidence intervals.
  • Sensitivity and specificity of anal human papillomavirus (HPV) testing to diagnose anal dysplasia [ Time Frame: Up to 5 years ]
    Will use the results of anoscopy as the true state of the patient and will estimate with 95% confidence intervals.
  • Sensitivity and specificity of the combination of anal pap testing + anal HPV testing to diagnose anal dysplasia [ Time Frame: Up to 5 years ]
    Will use the results of anoscopy as the true state of the patient and will estimate with 95% confidence intervals.
Original Primary Outcome Measures  ICMJE
 (submitted: May 14, 2014)
Prevalence of Invasive Squamous Cell Carcinoma of the Anus in Women with Cervical, Vaginal and Vulvar Dysplasia and Cancer [ Time Frame: 1 day ]
Prevalence of invasive squamous cell carcinoma of the anus estimated in women with each of the 3 diagnoses with 95% confidence intervals. Prevalence of anal dysplasia estimated in women with each of the 3 diagnoses. Results of anoscopy used as true state of the patient. Sensitivity and specificity of anal HPV testing estimated with 95% confidence intervals to diagnose anal dysplasia in women with each of the 3 diagnoses. Results of anoscopy used as true state of the patient. Sensitivity and specificity of combination of anal pap testing + anal HPV testing estimated with 95% confidence intervals to diagnose anal dysplasia in women with each of the 3 diagnoses.
Change History Complete list of historical versions of study NCT02140021 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biospecimen Collection and Testing for the Prevalence of Anal Dysplasia and Anal Cancer in Patients With Cervical, Vaginal and Vulvar Dysplasia and Cancer
Official Title  ICMJE Prevalence of Anal Dysplasia and Anal Cancer in Women With Cervical, Vaginal and Vulvar Dysplasia and Cancer
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Cervical Adenocarcinoma
  • Cervical Adenocarcinoma In Situ
  • Cervical Intraepithelial Neoplasia
  • Cervical Squamous Cell Carcinoma, Not Otherwise Specified
  • Cervical Squamous Intraepithelial Neoplasia
  • Early Invasive Cervical Adenocarcinoma
  • Early Invasive Cervical Squamous Cell Carcinoma
  • High Grade Cervical Squamous Intraepithelial Neoplasia
  • High Grade Vaginal Intraepithelial Neoplasia
  • Low Grade Vaginal Intraepithelial Neoplasia
  • Stage I Cervical Cancer AJCC v8
  • Stage I Vaginal Cancer AJCC v8
  • Stage I Vulvar Cancer AJCC v8
  • Stage IA Cervical Cancer AJCC v8
  • Stage IA Vaginal Cancer AJCC v8
  • Stage IA Vulvar Cancer AJCC v8
  • Stage IA1 Cervical Cancer AJCC v8
  • Stage IA2 Cervical Cancer AJCC v8
  • Stage IB Cervical Cancer AJCC v8
  • Stage IB Vaginal Cancer AJCC v8
  • Stage IB Vulvar Cancer AJCC v8
  • Stage IB1 Cervical Cancer AJCC v8
  • Stage IB2 Cervical Cancer AJCC v8
  • Stage II Cervical Cancer AJCC v8
  • Stage II Vaginal Cancer AJCC v8
  • Stage II Vulvar Cancer AJCC v8
  • Stage IIA Cervical Cancer AJCC v8
  • Stage IIA Vaginal Cancer AJCC v8
  • Stage IIA1 Cervical Cancer AJCC v8
  • Stage IIA2 Cervical Cancer AJCC v8
  • Stage IIB Cervical Cancer AJCC v8
  • Stage IIB Vaginal Cancer AJCC v8
  • Stage III Cervical Cancer AJCC v8
  • Stage III Vaginal Cancer AJCC v8
  • Stage III Vulvar Cancer AJCC v8
  • Stage IIIA Cervical Cancer AJCC v8
  • Stage IIIA Vulvar Cancer AJCC v8
  • Stage IIIB Cervical Cancer AJCC v8
  • Stage IIIB Vulvar Cancer AJCC v8
  • Stage IIIC Vulvar Cancer AJCC v8
  • Stage IV Cervical Cancer AJCC v8
  • Stage IV Vaginal Cancer AJCC v8
  • Stage IV Vulvar Cancer AJCC v8
  • Stage IVA Cervical Cancer AJCC v8
  • Stage IVA Vaginal Cancer AJCC v8
  • Stage IVA Vulvar Cancer AJCC v8
  • Stage IVB Cervical Cancer AJCC v8
  • Stage IVB Vaginal Cancer AJCC v8
  • Stage IVB Vulvar Cancer AJCC v8
  • Vaginal Adenocarcinoma
  • Vulvar Adenocarcinoma
  • Vulvar High Grade Squamous Intraepithelial Lesion
  • Vulvar Intraepithelial Neoplasia
  • Vulvar Squamous Cell Carcinoma
  • Vulvar Squamous Intraepithelial Lesion
Intervention  ICMJE
  • Procedure: Biospecimen Collection
    Undergo anal, cervical, vaginal, and oral sample collection
  • Other: Laboratory Biomarker Analysis
    Correlative studies
Study Arms  ICMJE Experimental: Screening (biospecimen collection)
Patients undergo collection of anal, cervical, vaginal, and oral samples during their scheduled pelvic exam.
Interventions:
  • Procedure: Biospecimen Collection
  • Other: Laboratory Biomarker Analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2014)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2020
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.
  • Women with a diagnosis of high grade intraepithelial lesion (HSIL) from a routine pap test.
  • Patients must sign an approved informed consent document.

Exclusion Criteria:

  • Patients with previously documented perianal squamous cell dysplasia or invasive squamous cell carcinoma of the anus or anal canal.
  • Patients unwilling or unable to provide informed consent for the study.
  • Male patients will not be included in this study.
  • Patients with previously documented HPV related oropharyngeal cancer.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02140021
Other Study ID Numbers  ICMJE 2014-0021
NCI-2018-02553 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2014-0021 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Kathleen Schmeler M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP