- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03208777
Telomeric Abnormalities in Colorectal Diseases by Fluorescent in Situ Hybridization Technique
Telomeric Abnormalities in Benign and Malignant Colorectal Diseases by Fluorescent in Situ Hybridization Technique
Colorectal carcinoma is a heterogeneous disease that is caused by the interaction of genetic and environmental factors. colorectal carcinoma encompasses a complex disease with different molecular pathways and biological characteristics arising from a multi-step process that implicates several genetic and epigenetic events . The multi-step genetic model involves the loss of function of tumor suppressor genes, such as adenomatous polyposis coli (APC), Telomeres could be a promising marker due to the fact that their lengths change in the colorectal polyp-carcinoma sequence . Moreover, telomere length (TL) is altered in blood cells in patients with colorectal carcinoma
- These findings could suggest that changes in TL may take place before the development of the tumor .
The two main forms of inflammatory bowel disease (IBD), ulcerative colitis (UC) and Crohn's disease (CD) are characterized by chronic intestinal inflammation and risk of progression to colon cancer. One proposed cause of the latter characteristic is chromosome instability, since the rearrangement of genetic material can lead to activation of oncogenes, loss of tumor suppressor genes and other changes that lead to uncontrolled cell growth. Chromosome instability is particularly associated with UC and has been observed in colon epithelial cells and peripheral blood mononuclear cell. Since genomic instability in peripheral blood mononuclear cells (PBMCs) has been used as a biomarker for global cancer risk in a number of diseases, the latter observation suggests the possibility of a chromosome instability syndrome in UC that could affect all tissues. One possible cause of chromosome instability is telomere dysfunction .
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Human chromosomes are capped and stabilized by telomeres, which not only protect them from damage but also have a role in regulating cellular senescence. After reaching a critical length, telomeres experience a double DNA change and cells will eventually enter senescence (replication) or cell death . Telomere length and telomere shortening have been long hypothesized to be a biological marker of aging at the cellular level and a potential mechanism of carcinogenesis. Genomic instability is a critical factor in the initiation and progression of human cancers. One mechanism that underlies genomic instability is loss of telomere function .
fluorescent in situ hybridization is a molecular diagnostic technique that utilizes labeled DNA probes to detect or confirm gene or chromosome abnormalities. fluorescent in situ hybridization is often utilized for both research and diagnosis of hematological malignancies and solid tumors. Conceptually, fluorescent in situ hybridization is a very straightforward technique whereby a DNA probe is hybridized to its complementary sequence on chromosomal preparations previously fixed on microscope slides . fluorescent in situ hybridization is able to detect cells that have chromosomal abnormalities consistent with neoplasia .
There has been a surge of published studies which assessed the association between telomere length and development of colorectal carcinoma. Thus, a meta-analysis addressing colorectal carcinoma and telomere length would be a useful addition to the current information in this area.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Adult age group ˃ 18 years.
- Newly diagnosed cases (no previous treatment).
- No treatment was taken for HCV infection.
Exclusion Criteria:
- age group < 18 years.
- Patients with malignancy of other type.
- Patients not diagnosed by endoscopy or biopsy (not surely diagnosed).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
control group
taking blood samples from apparently healthy people
|
taking blood samples and measure telomeric abnormalities
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benign colorectal
taking blood samples from patients
|
taking blood samples and measure telomeric abnormalities
|
malignant colorectal
taking blood samples from patients
|
taking blood samples and measure telomeric abnormalities
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
presence of telomeric abnormalities
Periodo de tiempo: one year
|
measure percentage of telomeric abnormalities in benign and malignant colorectal diseases
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one year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: fatma magdy zidan, residant, South Egypt Cancer Institute
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FISH
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Tumor Gástrico
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Aadi Bioscience, Inc.ReclutamientoTumor sólido avanzado | Tumor | Tumor SólidoEstados Unidos
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Sorrento Therapeutics, Inc.RetiradoTumor solido | Tumor sólido en recaída | Tumor refractario
-
Baodong QinReclutamientoTumor refractario | Tumor raroPorcelana
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Memorial Sloan Kettering Cancer CenterReclutamientoTumor solido | Tumor Sólido, Adulto | Tumor Sólido, No Especificado, AdultoEstados Unidos
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterReclutamientoTumor solido | Tumor Sólido, Adulto | Tumor Sólido, No Especificado, AdultoEstados Unidos, Puerto Rico
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterReclutamientoTumor solido | Tumor Sólido, Adulto | Tumor Sólido, No Especificado, AdultoEstados Unidos, Puerto Rico
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RemeGen Co., Ltd.TerminadoTumor sólido metastásico | Tumor sólido localmente avanzado | Tumor sólido irresecableAustralia
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BeiGeneReclutamientoTumor solido | Tumor sólido avanzadoEstados Unidos, Nueva Zelanda, Australia, Porcelana
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Second Affiliated Hospital of Soochow UniversitySciClone PharmaceuticalsReclutamientoTumor sólido avanzado | Tumor refractarioPorcelana
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Anjali PawarReclutamientoTumor solido | Tumor Sólido, InfanciaEstados Unidos
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The Hospital for Sick ChildrenTerminado
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Smiths Medical, ASD, Inc.Terminado
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Tokat Gaziosmanpasa UniversityTerminadoDientes primarios | Pulpotomía | Sangrado Pulpal; TinciónPavo
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Applied Science & Performance InstituteTerminadoDeficiencia de hierro (sin anemia)Estados Unidos
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Ischemia Care LLCTerminadoAccidente cerebrovascular isquémico | Fibrilación auricular | Accidente cerebrovascular trombótico | Ataques isquémicos transitorios | Accidente cerebrovascular cardioembólico | Accidente cerebrovascular de la arteria basilar | Eventos cerebrovasculares transitoriosEstados Unidos
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Tan Tock Seng HospitalMayo ClinicDesconocidoSepticemia | Fungemia | Bacteriemia | Infección del torrente sanguíneoSingapur
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University of California, IrvineNational Heart, Lung, and Blood Institute (NHLBI)ReclutamientoHipertensión | Adherencia a la medicaciónEstados Unidos