AIN3PACCONCT05060640
ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS.
An observational study of AIN3 and AIN2, run by University Fernando Pessoa at 1 site in Portugal.
Trial summary
HIV-positive patients, women with a history of genital neoplasia and patients under pharmacologically immunosuppression (e.g. transplanted recipients, Crohn´s disease and Lupus) are a high-risk population for anal human-papillomavirus infection and associated complications, like anal precancerous lesions and anal… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- AIN3, AIN2, HSIL, High Grade Squamous Intraepithelial Lesions
- What is being tested?
- Detection of anal HSIL in a routine colonoscopy.
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- 26 Aug 2021to 31 Aug 2024
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: HIV-positive patients, women with genital neoplasia (cervix, vulva and vagina), solid organ transplanted recipients, patients with inflammatory bowel disease and patients with Lupus.
Who may be able to join
- HIV-positive patients
- Solid transplanted recipients
- Crohn's disease patients under immunosuppression: steroids, thiopurines, biologics
- Patients with lupus under immunosuppression
- Women with a previous history of genital neoplasia (high-grade lesions or cancer) in the cervix, vagina or vulva.
Who cannot join
- Previous anal/perianal cancer history
- Previous known history of anal/perianal intraepithelial neoplasia
- Pelvic radiation
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Fernando Pessoa Teaching Hospital
Gondomar, Porto District, 4420-096
Andreia Albuquerque, MD PhD, 00351965501747, a.albuquerque.dias@gmail.com
About this study
Official title: PREVALENCE OF ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS DETECTED BY ROUTINE COLONOSCOPY (PACCO STUDY)
HIV-positive patients, women with a history of genital neoplasia and patients under pharmacologically immunosuppression (e.g. transplanted recipients, Crohn´s disease and Lupus) are a high-risk population for anal human-papillomavirus infection and associated complications, like anal precancerous lesions and anal squamous cell carcinoma. There is a lack of information on the prevalence of anal precancerous detected by routine colonoscopy in this population, by evaluating the squamocolumnar junction (the most susceptible area for lesions) during this procedure. Given, the increasing incidence rates of anal squamous cell carcinoma expected for the next two decades and the increase number of at-risk patients, the possible benefit of routine endoscopy in the diagnosis of anal precancerous lesions needs to be further explored.
Read the detailed description
Procedures in all patients:
- Digital anorectal evaluation
- Colonoscopy with retroflection and visualization of the anal squamocolumnar junction
- After identification of this area 5% acetic acid will be applied.
- Visualization under NBI/BLI.
- Biopsies of all the suspected lesions of anal high-grade squamous lesions (HSIL).
- Being tested
- Detection of anal HSIL in a routine colonoscopy.
- Medical subject headings
- Squamous Intraepithelial Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of anal HSIL in a routine colonoscopy.Procedure or surgery
Detection of anal HSIL in a routine colonoscopy by using acetic acid and NBI/BLI.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of anal high-grade squamous intraepithelial lesions in the squamocolumnar junction detected during routine colonoscopy.
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start26 Aug 2021
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIN3Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Fernando Pessoa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060640
- Sponsor's protocol ID
- 78A
- Acronym
- PACCO
- Status last verified
- Dec 2022
- First submitted
- 17 Sep 2021
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVALENCE OF ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS DETECTED BY ROUTINE COLONOSCOPY (PACCO STUDY)
- ClinicalTrials.gov ID
- NCT05060640
- Acronym / sponsor ID
- PACCO / 78A
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Fernando PessoaUniversity, hospital or other
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 29 Sep 2021 (actual)
- 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.
HIV-positive patients, women with a history of genital neoplasia and patients under pharmacologically immunosuppression (e.g. transplanted recipients, Crohn´s disease and Lupus) are a high-risk population for anal human-papillomavirus infection and associated complications, like anal precancerous lesions and anal squamous cell carcinoma. There is a lack of information on the prevalence of anal precancerous detected by routine colonoscopy in this population, by evaluating the squamocolumnar junction (the most susceptible area for lesions) during this procedure. Given, the increasing incidence rates of anal squamous cell carcinoma expected for the next two decades and the increase number of at-risk patients, the possible benefit of routine endoscopy in the diagnosis of anal precancerous lesions needs to be further explored.
Detailed description
Procedures in all patients:
- Digital anorectal evaluation
- Colonoscopy with retroflection and visualization of the anal squamocolumnar junction
- After identification of this area 5% acetic acid will be applied.
- Visualization under NBI/BLI.
- Biopsies of all the suspected lesions of anal high-grade squamous lesions (HSIL).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HIV-positive patients, women with genital neoplasia (cervix, vulva and vagina), solid organ transplanted recipients, patients with inflammatory bowel disease and patients with Lupus.
Key inclusion criteria (5 listed)
- HIV-positive patients
- Solid transplanted recipients
- Crohn's disease patients under immunosuppression: steroids, thiopurines, biologics
- Patients with lupus under immunosuppression
- Women with a previous history of genital neoplasia (high-grade lesions or cancer) in the cervix, vagina or vulva.
Key exclusion criteria (3 listed)
- Previous anal/perianal cancer history
- Previous known history of anal/perianal intraepithelial neoplasia
- Pelvic radiation
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 |
|---|---|---|
| Detection of anal HSIL in a routine colonoscopy.Detection of anal HSIL in a routine colonoscopy by using acetic acid and NBI/BLI. | Procedure or surgery | – |
Primary outcome
Prevalence of anal high-grade squamous intraepithelial lesions in the squamocolumnar junction detected during routine colonoscopy.
Time frame: through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Individual participant dataSharing planned: Undecided
Related trials for AIN3
RecruitingPhase 2
CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial
HSIL, High Grade Squamous Intraepithelial Lesion, HPV-Related Squamous Cell Carcinoma
Not yet recruiting
Anal Cancer Prevention in High-Risk Categories of Men Who Have Sex With Men
Anal HSIL, Anal AIN3
Active, not recruitingPhase 3
A Phase III Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent HPV Vaccine in Chinese Males
Genital Wart, Penile Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AIN3 and AIN2, run by University Fernando Pessoa at 1 site in Portugal.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreia Albuquerque, MD PhD (00351222455455, a.albuquerque.dias@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of anal high-grade squamous intraepithelial lesions in the squamocolumnar junction detected during routine colonoscopy. (time frame: through study completion, an average of 3 years). 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 12 Dec 2022.