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

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ClinicalTrials.gov Identifier: NCT03241680
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
Lyliana Coutinho Resende Barbosa, Universidade do Vale do Sapucai

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.


Condition or disease Intervention/treatment Phase
Anal Carcinoma Anal Condyloma Diagnostic Test: Search of anal citology alterations Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study of Anal Cytologies in Patients With High Grade Cervical Intraepithelial Neoplasia (CIN II and III)
Actual Study Start Date : August 2, 2017
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer

Arm Intervention/treatment
No Intervention: Control Group with conventional citology
Patients who do not have high grade cervical intraepithelial neoplasia and will have anal cytology performed by conventional method
No Intervention: Control Group with liquid based citology
Patients who do not have cervical intraepithelial neoplasia of high grade and will have anal cytology performed by liquid based method
No Intervention: CIN 2-3/Conventional Citology
Patients with high grade cervical intraepithelial neoplasia and will have anal citology performed by conventional method
Active Comparator: CIN 2-3/Liquid Based
Patients with high grade cervical intraepithelial neoplasia and will have anal citology performed by liquid based method
Diagnostic Test: Search of anal citology alterations

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 Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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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.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241680


Contacts
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Contact: LYLIANA C R BARBOSA 35988532927 magibarbosa@gmail.com

Locations
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Brazil
Lyliana C R Barbosa Recruiting
Pouso Alegre, MG, Brazil, 37550000
Contact: LYLIANA C R BARBOSA    35988532927    magibarbosa@gmail.com   
Contact: MARCIO E FRANCO RIBEIRO       marcioerikfr@hotmail.com   
Sponsors and Collaborators
Universidade do Vale do Sapucai
Investigators
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Study Chair: Daniela F Veiga Vale do Sapucai University

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Responsible Party: Lyliana Coutinho Resende Barbosa, MD Phd, Universidade do Vale do Sapucai
ClinicalTrials.gov Identifier: NCT03241680     History of Changes
Other Study ID Numbers: Citologia anal
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Anus Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases