RBR-788y7c Participation of the HPV virus in the appearance of laryngeal papillomas in patients from São Luís, Maranhão

Date of registration: 07/09/2020 ^(mm/dd/yyyy)
Last approval date : 07/09/2020 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1252-1515

• Public title:

  en

  Participation of the HPV virus in the appearance of laryngeal papillomas in patients from São Luís, Maranhão

  pt-br

  Participação do vírus HPV no aparecimento de papilomas de laringe em pacientes de São Luís, Maranhão

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 49681215610015087
    Issuing authority: Plataforma Brasil
  • 1.377.876
    Issuing authority: Comite de Ética em Pesquisa da UFMA

Sponsors

• Primary sponsor: UNIVERSIDADE FEDERAL DO MARANHÃO
• Secondary sponsor:
  • Institution: Fundação de Amparo à Pesquisa e ao Desenvolvimento Científico e Tecnológico do Maranhão
• Supporting source:
  • Institution: Fundação de Amparo à Pesquisa e ao Desenvolvimento Científico e Tecnológico do Maranhão

Health conditions

• Health conditions:

  en

  papilloma; laryngeal diseases

  pt-br

  papiloma; doenças da laringe

• General descriptors for health conditions:

  en

  C23 Pathological conditions, signs and symptoms

  pt-br

  C23 Condições patológicas, sinais e sintomas

  es

  C23 Condiciones patológicas, signos y síntomas

• Specific descriptors:

Interventions

• Interventions:

  en

  The study population consisted of patients of the University Hospital of the Federal University of Maranhão (HUUFMA), from July 2013 to August 2018, diagnosed with laryngeal papillomatosis. The only form of effective treatment is surgical intervention to remove lesions that may obstruct the larynx. Therefore, patients were referred for surgery. Before the surgical procedure, the patient and / or their guardian were approached. After explaining the research, reading the Informed Consent and consent, the samples were collected during surgery and stored in RNA Later (Life Technologies) at 4 ° C and, the next day, stored in a freezer at -80 ° C. The lesions extracted from the patient were subjected to DNA extraction and PCR analysis of the presence of HPV. Positive samples were sent for sequencing for viral genotyping. The clinical data of the patients were collected directly from the medical records.

  pt-br

  A população do estudo consistiu em indivíduos atendidos no Hospital Universitário da Universidade Federal do Maranhão (HUUFMA), no período de julho de 2013 a agosto de 2018, diagnosticados com papilomatose laríngea. A única forma de tratamento eficaz é a intervenção cirúrgica para retirada das lesões que podem obstruir a laringe. Os pacientes, portanto, eram encaminhados para a cirurgia. Antes do procedimento cirúrgico, o paciente e/ou seu responsável eram abordados. Após explicação da pesquisa, leitura do TCLE e consentimento, as amostras foram coletadas durante a cirurgia e acondicionadas em RNA Later (Life Technologies) a 4°C e, no dia seguinte, armazenadas em freezer a -80°C. As lesões extraídas do paciente eram submetidas a extração do DNA e análise da presença do HPV através da técnica de PCR. As amostras positivas foram encaminhadas para sequenciamento para genotipagem viral. Os dados clínicos dos pacientes foram coletados diretamente dos prontuários.

• Descriptors:

  en

  C01.925.256 DNA Virus Infections

  pt-br

  C01.925.256 Infecções por Vírus de DNA

  es

  C01.925.256 Infecciones por Virus ADN

  en

  L01.313.500.750.280 Information Storage and Retrieval

  pt-br

  L01.313.500.750.280 Armazenamento e Recuperação da Informação

  es

  L01.313.500.750.280 Almacenamiento y Recuperación de la Información

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 07/01/2013 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  13	-	0 -	0 -

• Inclusion criteria:

  en

  Individuals of all ages, of both sexes, who underwent surgery to remove the papillomas.

  pt-br

  Maiores e menores de idade, ambos os sexos, submetidos à cirurgia para retirada dos papilomas.

• Exclusion criteria:

  en

  Inadequate biological material (necrotic), scarce material

  pt-br

  Material biológico inadequado (necrótico), material escasso

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Prevention	Single-group	1	Open	Single-arm-study	N/A

Outcomes

• Primary outcomes:

  en

  Presence of the HPV virus in all laryngeal papilloma samples with a prevalence of low oncogenic risk types 6 and 11.

  pt-br

  Presença do vírus HPV em todas as amostras de papiloma de laringe com prevalência dos tipos de baixo risco oncogênico 6 e 11.

• Secondary outcomes:

  en

  Recurrent respiratory papillomatosis is more prevalent in children up to 12 years of age, and is also more aggressive with higher rates of recurrence and the need for tracheostomy.

  pt-br

  Papilomatose respiratória recorrente é mais prevalente em crianças até 12 anos, sendo também mais agressiva com maiores taxas de recorrência e necessidade de traqueostomia.

Contacts

• Public contact
  • Full name: Flavia Castello Branco Vidal
  • • Address: RUA COELHO NETO 311
    • City: SÃO LUÍS / Brazil
    • Zip code: 65.020-14
  • Phone: 55 98 21091273
  • Email: flavidal@hotmail.com
  • Affiliation: UNIVERSIDADE FEDERAL DO MARANHÃO
   
• Scientific contact
  • Full name: Flavia Castello Branco Vidal
  • • Address: RUA COELHO NETO 311
    • City: SÃO LUÍS / Brazil
    • Zip code: 65.020-14
  • Phone: 55 98 21091273
  • Email: flavidal@hotmail.com
  • Affiliation: UNIVERSIDADE FEDERAL DO MARANHÃO
   
• Site contact
  • Full name: Flavia Castello Branco Vidal
  • • Address: RUA COELHO NETO 311
    • City: SÃO LUÍS / Brazil
    • Zip code: 65.020-14
  • Phone: 55 98 21091273
  • Email: flavidal@hotmail.com
  • Affiliation: UNIVERSIDADE FEDERAL DO MARANHÃO
   

Additional links:

• Download in ICTRP format