Cervical AdenocarcinomaNCT02140021
Biospecimen Collection and Testing for the Prevalence of Anal Dysplasia and Anal Cancer in Patients With Cervical, Vaginal and Vulvar Dysplasia and Cancer
A study testing Biospecimen Collection and Laboratory Biomarker Analysis in people with Cervical Adenocarcinoma and Cervical Adenocarcinoma In Situ, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Adenocarcinoma, Cervical Adenocarcinoma In Situ, Cervical Intraepithelial Neoplasia
- What is being tested?
- Biospecimen Collection and Laboratory Biomarker Analysis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 409 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Oct 2014to 8 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lyndon Baines Johnson General Hospital
Houston, Texas, 77026-1967
M D Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Prevalence of Anal Dysplasia and Anal Cancer in Women With Cervical, Vaginal and Vulvar Dysplasia and Cancer
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- To estimate the prevalence of anal dysplasia in women with high-grade dysplasia or carcinoma of the cervix, vagina or vulva.
EXPLORATORY OBJECTIVES:
- 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.
- 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.
- Conditions
- Cervical Adenocarcinoma, Cervical Adenocarcinoma In Situ, Cervical Intraepithelial Neoplasia, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Cervical Squamous Intraepithelial Neoplasia, Early Invasive Cervical Adenocarcinoma
- Being tested
- Biospecimen Collection, Laboratory Biomarker Analysis
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo anal, cervical, vaginal, and oral sample collection
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Screening (biospecimen collection) | Experimental | Patients undergo collection of anal, cervical, vaginal, and oral samples during their scheduled pelvic exam. Receives: Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study start27 Oct 2014
- Primary completion8 Jul 2025
- Study completion8 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kathleen Schmeler, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140021
- Sponsor's protocol ID
- 2014-0021
- Other IDs
- NCI-2018-02553, 2014-0021
- Status last verified
- Jul 2025
- First submitted
- 14 May 2014
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Anal Dysplasia and Anal Cancer in Women With Cervical, Vaginal and Vulvar Dysplasia and Cancer
- ClinicalTrials.gov ID
- NCT02140021
- Acronym / sponsor ID
- 2014-0021
- Conditions
- Cervical Adenocarcinoma, Cervical Adenocarcinoma In Situ, Cervical Intraepithelial Neoplasia, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Cervical Squamous Intraepithelial Neoplasia, Early Invasive Cervical Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 409 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Oct 2014 (actual)
- Primary completion
- 8 Jul 2025 (actual)
- Study completion
- 8 Jul 2025 (actual)
- First posted
- 16 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- To estimate the prevalence of anal dysplasia in women with high-grade dysplasia or carcinoma of the cervix, vagina or vulva.
EXPLORATORY OBJECTIVES:
- 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.
- 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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (biospecimen collection) | Experimental | Procedure: Biospecimen Collection, Other: Laboratory Biomarker AnalysisPatients undergo collection of anal, cervical, vaginal, and oral samples during their scheduled pelvic exam. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionUndergo anal, cervical, vaginal, and oral sample collection | Procedure or surgery | Screening (biospecimen collection) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Screening (biospecimen collection) |
Primary outcome
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.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Schmeler principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection and Laboratory Biomarker Analysis in people with Cervical Adenocarcinoma and Cervical Adenocarcinoma In Situ, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of invasive squamous cell carcinoma of the anus (time frame: Up to 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.