Public trial
RBR-9tt23hz Evaluation of genetic changes, organism imbalance and gene expression in patients with Amyotrophic Lateral Sclerosis (AL...
Date of registration: 09/30/2021 (mm/dd/yyyy)Last approval date : 09/30/2021 (mm/dd/yyyy)
Study type:
Observational
Scientific title:
en
Evaluation of genetic alterations, oxidative stress and gene expression in patients with Amyotrophic Lateral Sclerosis (ALS)
pt-br
Avaliação de alterações genéticas, de estresse oxidativo e de expressão gênica em pacientes com Esclerose Lateral Amiotrófica (ELA)
es
Evaluation of genetic alterations, oxidative stress and gene expression in patients with Amyotrophic Lateral Sclerosis (ALS)
Trial identification
- UTN code:
-
Public title:
en
Evaluation of genetic changes, organism imbalance and gene expression in patients with Amyotrophic Lateral Sclerosis (ALS)
pt-br
Avaliação de alterações genéticas, desequilíbrio do organismo e expressão de genes em pacientes com Esclerose Lateral Amiotrófica (ELA)
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Scientific acronym:
en
Amyotrophic Lateral Sclerosis (ALS)
pt-br
Esclerose Lateral Amiotrófica (ELA)
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Public acronym:
-
Secondaries identifiers:
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43827215.1.0000.5411
Issuing authority: Plataforma Brasil
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1.048.441
Issuing authority: Comite de etica - Faculdade de Medicina de Botucatu - UNESP
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43827215.1.0000.5411
Sponsors
- Primary sponsor: Faculade de Medina de Botucatu - UNESP
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Secondary sponsor:
- Institution: Departamento de Anestesiologia
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Supporting source:
- Institution: FAPESP - Fundação de Amparo à Pesquisa do Estado de São Paulo
Health conditions
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Health conditions:
en
Amyotrophic lateral sclerosis
pt-br
Esclerose lateral amiotrófica
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General descriptors for health conditions:
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Specific descriptors:
en
G96 Esclerose Amiotrófica Lateral
pt-br
G96 Esclerose Amiotrófica Lateral
Interventions
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Interventions:
en
A sample of blood and material from the oral cavity will be collected from 30 patients with ALS and 30 healthy controls, all over 18 years of age. ALS patients will be recruited at the Neuromuscular Diseases and Neuroimmunology Clinic, Hospital das Clínicas, Faculty of Medicine of Botucatu. A detailed questionnaire will also be applied, including demographic data, medical history, lifestyle, personal and family history for other neurological diseases, with an average application time of 20 minutes for all participants. The collection time of material and demographic data will be approximately 4 months
pt-br
Serão coletados amostra de sangue e material da cavidade oral de 30 pacientes portadores de ELA e 30 controles saudáveis, todos acima de 18 anos de idade. Os pacientes com ELA serão recrutados no Ambulatório de Doenças Neuromuscular e Neuroimunologia, do Hospital das Clínicas da Faculdade de Medicina de Botucatu. Será também aplicado questionário detalhado que incluem dados demográficos, de história médica, estilo de vida antecedentes pessoais e familiares para outras doenças neurológicas, com tempo médio de aplicação de 20 minutos para todos os participantes. O tempo de coleta de material e dados demográficas será de aproximadamente 4 meses
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Descriptors:
en
Z01 Blood Specimen Collection
pt-br
Z01 Coleta de Amostras Sanguíneas
Recruitment
- Study status: Recruitment completed
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Countries
- Brazil
- Date first enrollment: 05/10/2015 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 30 - 0 0 -
Inclusion criteria:
en
Patients diagnosed with ALS; whether or not receiving treatment with Riluzole medication; of both sexes; over 18 years.
pt-br
Pacientes diagnosticados com ELA; recebendo ou não tratamento com medicação Riluzole; de ambos os sexos; acima de 18 anos.
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Exclusion criteria:
en
Patients diagnosed with other neurological pathologies
pt-br
Pacientes diagnosticados com outras patologias neurológicas
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase
Outcomes
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Primary outcomes:
en
Evaluate the frequency of micronuclei and cytological changes in exfoliated cells of the oral mucosa, damage to the genome, oxidative stress and expression of genes involved in oxidative stress in patients with ALS
pt-br
Avaliar a frequência de micronúcleos e alterações citológicas em células esfoliadas da mucosa oral, danos no genoma, estresse oxidativo e expressão de genes envolvidos no estresse oxidativo nos pacientes portadores de ELA
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Secondary outcomes:
en
No secondary outcomes are expected
pt-br
Não são esperados desfechos secundários
Contacts
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Public contact
- Full name: Rodrigo Juliano Oliveira
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- Address:
- City: Campo Grande / Brazil
- Zip code:
- Phone: 55 67 984346510
- Email: rodrigo.olveira@ufms.br
- Affiliation:
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Scientific contact
- Full name: Mariana Gobbo Braz
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- Address: Avenida Professor Mario Rubens Guimaraes Montenegro s/N
- City: Botucatu / Brazil
- Zip code: 18.618-687
- Phone: +55-14-38801650
- Email: mgbraz@hotmail.com
- Affiliation:
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Site contact
- Full name: Mariana Gobbo Braz
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- Address: Avenida Professor Mario Rubens Guimaraes Montenegro s/N
- City: Botucatu / Brazil
- Zip code: 18.618-687
- Phone: +55-14-38801650
- Email: mgbraz@hotmail.com
- Affiliation:
Additional links:
Total de Ensaios Clínicos 16962.
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