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

NCT03241680 | Unknown DMC

• 1 other identifier: Citologia anal
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal Carcinoma; Anal Condyloma

Outcome Measures

Primary Outcomes (1)

• 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

  Six months

Study Arms (4)

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

Diagnostic Test: Search of anal citology alterations

Interventions

Search of anal citology alterations DIAGNOSTIC_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).

CIN 2-3/Liquid Based

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidade do Vale do Sapucai: lead

Study Sites (1)

Lyliana C R Barbosa

Pouso Alegre, Minas Gerais, 37550000, Brazil

RECRUITING

MeSH Terms

Conditions

Anus Neoplasms

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Study Officials

• Daniela F Veiga

  Vale do Sapucai University

  STUDY CHAIR

Central Study Contacts

LYLIANA C R BARBOSA

CONTACT

35988532927; magibarbosa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Phd

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 7, 2017
• Study Start: August 2, 2017
• Primary Completion: April 30, 2018
• Study Completion: May 31, 2018
• Last Updated: August 7, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)