Avaliação de Pacientes com Doença Gastrointestinal
Background:
Ongoing and future research projects that study gastrointestinal diseases depend on access to biological samples and clinical data. Researchers want to study people who are seen and treated for these diseases. This may help them assess and treat these diseases better in the future.
Objective:
To collect data and samples from people being seen and/or treated for gastrointestinal problems at NIH, to use in future research.
Eligibility:
Adults aged 18 and older who have known or suspected gastrointestinal disorders or need screening, treatment, or follow-up per current medical guidelines.
Design:
Participants will be screened with a physical exam. Their medical records will be reviewed.
Participants will be seen by doctors based on the ailment they have. Their condition will be treated just like it would at a doctor s office. But the data and samples collected will be used for future research.
Participants may give blood, urine, and/or stool samples.
If participants have an endoscopy or colonoscopy as part of their standard care and samples are taken, they may be asked to give their leftover samples to NIH. Or, they may be asked to have extra samples taken for NIH to use. These samples may include gastric acid and/or tissue from the lining of the stomach or intestines. If samples are not taken as part of their standard care, they may be asked to have samples taken for NIH to use.
Data will be stored at NIH. The data systems are password protected. Samples will be coded.
Participants will take part in the study for as long as they agree to be seen for their disease....
Visão geral do estudo
Status
Descrição detalhada
Patients with suspected or established acute or chronic gastrointestinal diseases or who require clinical screening for gastrointestinal diseases are provided standard clinical care for their condition. Data and samples obtained during regular clinical care will be retained for future research in gastrointestinal diseases. Recommendations for other treatment options outside of the NIH will be discussed with study patients and may be discussed with their primary or referring physicians.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Sheila Kumar, M.D.
- Número de telefone: (301) 496-9730
- E-mail: sheila.kumar@nih.gov
Estude backup de contato
- Nome: Gladys L Salas
- Número de telefone: (301) 594-0636
- E-mail: gladys.salas@nih.gov
Locais de estudo
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892
- Recrutamento
- National Institutes of Health Clinical Center
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Contato:
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
- Número de telefone: TTY8664111010 800-411-1222
- E-mail: prpl@cc.nih.gov
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Patients with known or suspected gastrointestinal disease.
Descrição
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Male or female, aged >= 18 years of age
- Known or suspected gastrointestinal disorders or requiring clinical screening, management and/or treatment and follow-up per current American Gastroenterological Association (AGA), American Society for Gastrointestinal Endoscopy (ASGE) or the American Association for the Study of Liver Disease (AASLD).
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Significant medical illnesses that the investigators feel may interfere with potential evaluations.
- Absence of a referring community physician who would be able to manage care outside of the NIH.
- Any medical, psychiatric, or social conditions which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the patient.
- Inability to provide informed consent.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
|---|
|
Study Cohort
Patients with known or suspected gastrointestinal disease |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
To collect data and samples during clinical evaluation, treatment and follow-up of participants for future use in studies of gastrointestinal diseases.
Prazo: End of study
|
Development of a data set comprised of results and observations obtained during standard clinical care of patients with known or suspected gastrointestinal disease and collection of samples to be used for future research. |
End of study
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Sheila Kumar, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 10000247
- 000247-DK
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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