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Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III)

Primary Purpose

Anal Carcinoma, Anal Condyloma

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Search of anal citology alterations
Sponsored by
Universidade do Vale do Sapucai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anal Carcinoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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.

-

Exclusion Criteria:

Patients who withdraw the consent term. History of previous anal cancer / anal intraepithelial neoplasia. Immunosuppressed: HIV, SLE, users of immunosuppressive and transplanted drugs.

-

Sites / Locations

  • Lyliana C R BarbosaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

No Intervention

No Intervention

Active Comparator

Arm Label

Control Group with conventional citology

Control Group with liquid based citology

CIN 2-3/Conventional Citology

CIN 2-3/Liquid Based

Arm Description

Patients who do not have high grade cervical intraepithelial neoplasia and will have anal cytology performed by conventional method

Patients who do not have cervical intraepithelial neoplasia of high grade and will have anal cytology performed by liquid based method

Patients with high grade cervical intraepithelial neoplasia and will have anal citology performed by conventional method

Patients with high grade cervical intraepithelial neoplasia and will have anal citology performed by liquid based method

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 2, 2017
Last Updated
August 2, 2017
Sponsor
Universidade do Vale do Sapucai
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1. Study Identification

Unique Protocol Identification Number
NCT03241680
Brief Title
Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III)
Official Title
Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Anticipated)
Study Completion Date
May 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Vale do Sapucai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Carcinoma, Anal Condyloma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group with conventional citology
Arm Type
No Intervention
Arm Description
Patients who do not have high grade cervical intraepithelial neoplasia and will have anal cytology performed by conventional method
Arm Title
Control Group with liquid based citology
Arm Type
No Intervention
Arm Description
Patients who do not have cervical intraepithelial neoplasia of high grade and will have anal cytology performed by liquid based method
Arm Title
CIN 2-3/Conventional Citology
Arm Type
No Intervention
Arm Description
Patients with high grade cervical intraepithelial neoplasia and will have anal citology performed by conventional method
Arm Title
CIN 2-3/Liquid Based
Arm Type
Active Comparator
Arm Description
Patients with high grade cervical intraepithelial neoplasia and will have anal citology performed by liquid based method
Intervention Type
Diagnostic Test
Intervention Name(s)
Search of anal citology alterations
Intervention Description
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).
Primary Outcome Measure Information:
Title
Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III)
Description
Search for alterations in the anal cytology of patients with CIN 2-3 in conventional and liquid based anal citology
Time Frame
Six months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. - Exclusion Criteria: Patients who withdraw the consent term. History of previous anal cancer / anal intraepithelial neoplasia. Immunosuppressed: HIV, SLE, users of immunosuppressive and transplanted drugs. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LYLIANA C R BARBOSA
Phone
35988532927
Email
magibarbosa@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela F Veiga
Organizational Affiliation
Vale do Sapucai University
Official's Role
Study Chair
Facility Information:
Facility Name
Lyliana C R Barbosa
City
Pouso Alegre
State/Province
MG
ZIP/Postal Code
37550000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LYLIANA C R BARBOSA
Phone
35988532927
Email
magibarbosa@gmail.com
First Name & Middle Initial & Last Name & Degree
MARCIO E FRANCO RIBEIRO
Email
marcioerikfr@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III)

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