Anal CarcinomaNCT03241680
Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III)
A study testing Search of anal citology alterations in people with Anal Carcinoma and Anal Condyloma, run by Universidade do Vale do Sapucai at 1 site in Brazil.
Trial summary
Cervical cancer is the third most frequent neoplasm in Brazilian women (estimated risk of 15.33 cases / 100,000 women by 2014), behind breast and colorectal cancer. This high incidence is explained by the pre-neoplastic lesions of the cervix being probably related to the practice of unsafe sex and to a poor local… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anal Carcinoma, Anal Condyloma
- What is being tested?
- Search of anal citology alterations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Aug 2017to 31 May 2018
- 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female patients aged 18-65 years with an anatomic pathology compatible with CIN II / CIN III, without restriction regarding skin color, race, ethnicity, religion; Patients of the Oncology Gynecology Service of the HCSL, registered in the hospital management system, in outpatient consultations; Those who agree to participate in the study and sign the ICF. Patients attended at the general gynecological surgery outpatient clinic (control group) with no evidence of colpocitological alteration.
- -
Who cannot join
- Patients who withdraw the consent term. History of previous anal cancer / anal intraepithelial neoplasia. Immunosuppressed: HIV, SLE, users of immunosuppressive and transplanted drugs.
- -
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Lyliana C R Barbosa
Pouso Alegre, Minas Gerais, 37550000
LYLIANA C R BARBOSA, 35988532927, magibarbosa@gmail.com
MARCIO E FRANCO RIBEIRO, marcioerikfr@hotmail.com
About this study
Cervical cancer is the third most frequent neoplasm in Brazilian women (estimated risk of 15.33 cases / 100,000 women by 2014), behind breast and colorectal cancer.
This high incidence is explained by the pre-neoplastic lesions of the cervix being probably related to the practice of unsafe sex and to a poor local immune response against HPV.
Read more
Human papillomavirus (HPV) infection affects people of any age, although it is more common in young people, probably due to increased sexual activity in that period.
The association between high-risk HPV and anus neoplasm in men and women with immunodeficiency or immunosuppression has been confirmed and measures related to surveillance are standardized.
In patients without immunodeficiencies, this association is still unclear, which may contribute to the lack of adequate standards to diagnose HPV and prevent cancer of the anus.
The frequency of the cancer of anus previously considered low, is currently in considerable elevation, mainly squamous cell carcinoma (SCC).
The causal relationship between this virus and cancer of the cervix and the anus is established. These facts have motivated the inclusion of this disease as STD, which justifies the necessity of adopting surveillance measures in the clinics of sexual, gynecological and urological diseases.
Cancer of the anus, when diagnosed in the early stage, makes healing possible with less aggressive treatments, but in the advanced stage, abdominoperineal amputation is necessary.
Concerned about possible anal cancer, some gynecologists have referred patients with genital HPV to search for anal infection.
- Conditions
- Anal Carcinoma, Anal Condyloma
- Being tested
- Search of anal citology alterations
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Search of anal citology alterationsDiagnostic test
All patients with a pathological diagnosis of CIN II and III, and in the general gynecological surgery outpatient clinic, will be selected at the outpatient clinic of Oncology Gynecology of the HCSL for a period of six months.
Patients who meet the eligibility criteria will be clarified about the study, and only those who agree to participate will be included, by signing the informed consent form (TCLE).
| Study group | Role | What they receive |
|---|---|---|
| Control Group with conventional citology | No intervention | Patients who do not have high grade cervical intraepithelial neoplasia and will have anal cytology performed by conventional method |
| Control Group with liquid based citology | No intervention | Patients who do not have cervical intraepithelial neoplasia of high grade and will have anal cytology performed by liquid based method |
| CIN 2-3/Conventional Citology | No intervention | Patients with high grade cervical intraepithelial neoplasia and will have anal citology performed by conventional method |
| CIN 2-3/Liquid Based | Active comparator | Patients with high grade cervical intraepithelial neoplasia and will have anal citology performed by liquid based method Receives: Diagnostic Test: Search of anal citology alterations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III)
Search for alterations in the anal cytology of patients with CIN 2-3 in conventional and liquid based anal citology
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start2 Aug 2017
- Primary completion30 Apr 2018 (estimated)
- Study completion31 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CarcinomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Sapucai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lyliana Coutinho Resende Barbosa, Universidade do Vale do Sapucai
- Investigators
- Daniela F Veiga, Study chair, Vale do Sapucai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241680
- Sponsor's protocol ID
- Citologia anal
- Status last verified
- Aug 2017
- First submitted
- 2 Aug 2017
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III)
- ClinicalTrials.gov ID
- NCT03241680
- Acronym / sponsor ID
- Citologia anal
- Conditions
- Anal Carcinoma, Anal Condyloma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidade do Vale do SapucaiUniversity, hospital or other
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 31 May 2018 (estimated)
- First posted
- 7 Aug 2017 (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.
Cervical cancer is the third most frequent neoplasm in Brazilian women (estimated risk of 15.33 cases / 100,000 women by 2014), behind breast and colorectal cancer.
This high incidence is explained by the pre-neoplastic lesions of the cervix being probably related to the practice of unsafe sex and to a poor local immune response against HPV.
Human papillomavirus (HPV) infection affects people of any age, although it is more common in young people, probably due to increased sexual activity in that period.
The association between high-risk HPV and anus neoplasm in men and women with immunodeficiency or immunosuppression has been confirmed and measures related to surveillance are standardized.
In patients without immunodeficiencies, this association is still unclear, which may contribute to the lack of adequate standards to diagnose HPV and prevent cancer of the anus.
The frequency of the cancer of anus previously considered low, is currently in considerable elevation, mainly squamous cell carcinoma (SCC).
The causal relationship between this virus and cancer of the cervix and the anus is established. These facts have motivated the inclusion of this disease as STD, which justifies the necessity of adopting surveillance measures in the clinics of sexual, gynecological and urological diseases.
Cancer of the anus, when diagnosed in the early stage, makes healing possible with less aggressive treatments, but in the advanced stage, abdominoperineal amputation is necessary.
Concerned about possible anal cancer, some gynecologists have referred patients with genital HPV to search for anal infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group with conventional citology | No intervention | –Patients who do not have high grade cervical intraepithelial neoplasia and will have anal cytology performed by conventional method |
| Control Group with liquid based citology | No intervention | –Patients who do not have cervical intraepithelial neoplasia of high grade and will have anal cytology performed by liquid based method |
| CIN 2-3/Conventional Citology | No intervention | –Patients with high grade cervical intraepithelial neoplasia and will have anal citology performed by conventional method |
| CIN 2-3/Liquid Based | Active comparator | Diagnostic Test: Search of anal citology alterationsPatients with high grade cervical intraepithelial neoplasia and will have anal citology performed by liquid based method |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female patients aged 18-65 years with an anatomic pathology compatible with CIN II / CIN III, without restriction regarding skin color, race, ethnicity, religion; Patients of the Oncology Gynecology Service of the HCSL, registered in the hospital management system, in outpatient consultations; Those who agree to participate in the study and sign the ICF. Patients attended at the general gynecological surgery outpatient clinic (control group) with no evidence of colpocitological alteration.
- -
Key exclusion criteria (2 listed)
- Patients who withdraw the consent term. History of previous anal cancer / anal intraepithelial neoplasia. Immunosuppressed: HIV, SLE, users of immunosuppressive and transplanted drugs.
- -
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 |
|---|---|---|
| Search of anal citology alterationsAll patients with a pathological diagnosis of CIN II and III, and in the general gynecological surgery outpatient clinic, will be selected at the outpatient clinic of Oncology Gynecology of the HCSL for a period of six months. Patients who meet the eligibility criteria will be clarified about the study, and only those who agree to participate will be included, by signing the informed consent form (TCLE). | Diagnostic test | CIN 2-3/Liquid Based |
Primary outcome
Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III)
Time frame: Six months
Search for alterations in the anal cytology of patients with CIN 2-3 in conventional and liquid based anal citology
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Anal Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage Anal Cancer
Anal Cancer
Active, not recruitingPhase 2
Anti-PD-1 and mDCF Followed by Chemoradiotherapy in Patients With Stage III Squamous Cell Anal Carcinoma.
Squamous Cell Carcinoma of the Anus Stage III
Recruiting
Distance-Based Exercise to Preserve Function and Prevent Disability
Localized Malignant Solid Neoplasm, Anal Cancer
Active, not recruitingPhase 2
Combination of Spartalizumab, mDCF and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma
Squamous Cell Anal Carcinoma, Metastatic Squamous Cell Carcinoma
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.
Daniela F Veiga study chair
Vale do Sapucai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Search of anal citology alterations in people with Anal Carcinoma and Anal Condyloma, run by Universidade do Vale do Sapucai at 1 site in Brazil.
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 2 inclusion and 2 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 7 Aug 2017. 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 Brazil. 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 LYLIANA C R BARBOSA (35988532927, magibarbosa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III) (time frame: Six months). 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 7 Aug 2017.