NCT04512508

Brief Summary

The diagnosis of anal cancer is superior with the Anal Test system compared to liquid cytology and anoscopy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
17 days until next milestone

Study Start

First participant enrolled

August 30, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

1 month

First QC Date

July 30, 2020

Last Update Submit

August 11, 2020

Conditions

Anal InjuryAnal Cancer

Keywords

Anal cancerAnal testAnoscopyHPV

Outcome Measures

Primary Outcomes (1)

  • Percentage of positive results for Anal Test system versus anal liquid cytology and anoscopy for the presence of high-risk human papillomaviruses

    Statistical difference for percentages of the presence of high-risk human papillomaviruses between self-test versus liquid anal cytology.

    12 months

Secondary Outcomes (4)

  • Number of predictive value for positive and negative results for self-test versus liquid cytology results

    12 months

  • Number and percentage of patients with anal intraepithelial lesions caused by HPV-Ar infection compared between HIV-positive and HIV-negative patients

    12 months

  • Number and percentage of LSIL and HSIL for patients using self-test (by presence of mRNA for viral proteins E6 and E7) compared to number and percentage of LSIL and HSIL for patients with liquid cytology or with results by biopsy.

    12 months

  • Number and percentage of patients to have a positive opinion to use Self-Test system.

    12 months

Study Arms (2)

Group 1, HIV negative patients.

OTHER

Only HIV negative patients

Diagnostic Test: Self test sample

Group 2, HIV positive patients

OTHER

Only HIV positive patients

Diagnostic Test: Self test sample

Interventions

Self test sampleDIAGNOSTIC_TEST

Self test sample, DNA analysis, Biopsy and Anoscopy

Also known as: Citology sample
Group 1, HIV negative patients.Group 2, HIV positive patients

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women between 30 and 65 years old.
  • They agree to participate in the study and sign informed consent.
  • They have not received previous treatments for HPV or had previous intraepithelial lesions or anal cancer.
  • Immunosuppressed patients.
  • Women with LIAG of the genital tract (cervix, vagina, or vulva).
  • Patients who have had anal intercourse

You may not qualify if:

  • Patients sexually inactive
  • Subjects who had anal sex in less than 24 hours prior to the study.
  • Patients with local medication application (enemas, suppositories).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General de México Eduardo Liceaga

Mexico City, 06720, Mexico

Location

MeSH Terms

Conditions

Anus Neoplasms

Condition Hierarchy (Ancestors)

Rectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal Diseases

Study Officials

  • Luis G Molina Fernández de Lara

    Hospital General de México Eduardo Liceaga

    STUDY CHAIR

Central Study Contacts

Carlos E Aranda Flores

CONTACT

5550043807aranda_floresc@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: A randomized and consecutive number will be assigned. If it is a non-number, the self-test will be performed first, followed by liquid cytology and then anoscopy. If it is a even number, first the liquid cytology will be performed, then the autotoma and the anoscopy
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgeon, specialty in oncology

Study Record Dates

First Submitted

July 30, 2020

First Posted

August 13, 2020

Study Start

August 30, 2020

Primary Completion

September 30, 2020

Study Completion

January 31, 2021

Last Updated

August 13, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)