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- Ensayo clínico NCT02535026
An Observational Study on Human Epidermal Growth Factor Receptor (HER) 2 Status of Breast Invasive Carcinoma in Latin American Participants
24 de febrero de 2017 actualizado por: Hoffmann-La Roche
Epidemiological, Prospective and Observational Study on the HER2 Status in Breast Invasive Carcinomas Assessed by Immunohistochemistry (IHC) and Silver In-situ Hybridization (SISH) in a Sample of Latin-American Patients
This is a descriptive, prospective, observational and epidemiological study on participants recently diagnosed with breast cancer to evaluate the HER2 status by IHC and SISH procedures.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
De observación
Inscripción (Actual)
580
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Método de muestreo
Muestra no probabilística
Población de estudio
Breast tissue samples from female participants with a breast cancer diagnosis that undergo an anatomopathological examination of surgical specimens and/or core needle biopsies when surgery is not possible.
Descripción
Inclusion Criteria:
- Anatomopathological samples (surgical specimens or when a surgical sample is not possible, a core needle biopsy may be used) from female participants with a histopathological diagnosis of invasive breast cancer
Exclusion Criteria:
- Samples whose residual material in the paraffin block(s) is insufficient for neoplasm representation in the procedures in this study
- Cancer samples that have received previous chemotherapy treatment
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Solo caso
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
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Breast Cancer Participants
Breast tissue samples from female participants with a breast cancer diagnosis that undergo an anatomopathological examination of surgical specimens and/or core needle biopsies will be considered for analysis in this study.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percentage of Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Status in Breast Cancer Specimens Using Immunohistochemistry (IHC) and Silver In-Situ Hybridization (SISH) Procedures
Periodo de tiempo: Baseline up to 30 months
|
HER2 status of the collected tissue samples was determined based on the results obtained from IHC test and SISH procedure.
The IHC test gives a score of 0 to 3 positive (+) that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample.
If the score is 0 to 1+, it's called "HER2 negative (-)."
If the score is 2+, it's called "borderline."
A score of 3+ is called "HER2 positive."
Tissue samples which had the IHC score of 2+ (borderline) were re-tested using SISH procedure for confirmation of the HER2 status.
Tissue samples with SISH test results + were considered as HER2+.
Tissue samples for which HER2 status was not determined were considered as HER2 equivocal.
|
Baseline up to 30 months
|
Percentage of Participants With Different Phenotypes of Breast Cancer
Periodo de tiempo: Baseline up to 30 months
|
Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were estrogen receptor (ER) + and/or progesterone receptor (PR) +, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.
Histological grading was done by Nottingham Histologic Score system based on three factors, a) the amount of gland formation (differentiation), b) the nuclear features (pleomorphism) and c) the mitotic activity.
Each of these features is scored from 1-3, and then each score is added to give a final total score ranging from 3-9.
The final total score is used to determine the grade in the following way: i) Grade 1 tumors have a score of 3-5, ii) Grade 2 tumors have a score of 6-7, and iii) Grade 3 tumors have a score of 8-9.
|
Baseline up to 30 months
|
Percentage of Participants With Histological Sub-types of Breast Cancer
Periodo de tiempo: Baseline up to 30 months
|
Histological subtypes of breast cancer included ductal carcinoma, lobular carcinoma, mucinous carcinoma, mixed carcinoma, metaplastic carcinoma, and others.
|
Baseline up to 30 months
|
Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups
Periodo de tiempo: Baseline up to 30 months
|
Participants were categorized in to following age groups: a) less than (<) 40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) greater than or equal to (≥) 70 years.
|
Baseline up to 30 months
|
Percentage of Participants With ER Status (Positive or Negative) Based on Nuclear Grades
Periodo de tiempo: Baseline up to 30 months
|
Nuclear pleomorphism was observed and graded accordingly.
Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.
|
Baseline up to 30 months
|
Percentage of Participants With ER Status (Positive or Negative) Based on Lymphovascular Invasion
Periodo de tiempo: Baseline up to 30 months
|
Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels.
|
Baseline up to 30 months
|
Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups
Periodo de tiempo: Baseline up to 30 months
|
Participants were categorized in to following age groups: a) <40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) ≥70 years.
|
Baseline up to 30 months
|
Percentage of Participants With PR Status (Positive or Negative) Based on Nuclear Grades
Periodo de tiempo: Baseline up to 30 months
|
Nuclear pleomorphism was observed and graded accordingly.
Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.
|
Baseline up to 30 months
|
Percentage of Participants With PR Status (Positive or Negative) Based on Lymphovascular Invasion
Periodo de tiempo: Baseline up to 30 months
|
Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels.
|
Baseline up to 30 months
|
Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups
Periodo de tiempo: Baseline up to 30 months
|
Participants were categorized in to following age groups: a) <40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) ≥70 years.
|
Baseline up to 30 months
|
Percentage of Participants With HER2 Status (Positive or Negative) Based on Nuclear Grades
Periodo de tiempo: Baseline up to 30 months
|
Nuclear pleomorphism was observed and graded accordingly.
Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.
|
Baseline up to 30 months
|
Percentage of Participants With HER2 Status (Positive or Negative) Based on Lymphovascular Invasion
Periodo de tiempo: Baseline up to 30 months
|
Lymphovascular invasion is entering of breast cancer cells in to the lymph or blood/vascular channels.
|
Baseline up to 30 months
|
Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups
Periodo de tiempo: Baseline up to 30 months
|
Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.
Participants were categorized in to following age groups: a) <40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) ≥70 years.
|
Baseline up to 30 months
|
Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades
Periodo de tiempo: Baseline up to 30 months
|
Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.
Nuclear pleomorphism was observed and graded accordingly.
Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.
|
Baseline up to 30 months
|
Percentage of Participants With Different Phenotypes of Breast Cancer Based on Lymphovascular Invasion
Periodo de tiempo: Baseline up to 30 months
|
Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.
Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels.
|
Baseline up to 30 months
|
Percentage of Participants With Different Phenotypes of Breast Cancer Based on ER Status
Periodo de tiempo: Baseline up to 30 months
|
Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.
|
Baseline up to 30 months
|
Percentage of Participants With Different Phenotypes of Breast Cancer Based on PR Status
Periodo de tiempo: Baseline up to 30 months
|
Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.
|
Baseline up to 30 months
|
Percentage of Participants With Different Phenotypes of Breast Cancer Based on HER2 Status
Periodo de tiempo: Baseline up to 30 months
|
Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.
|
Baseline up to 30 months
|
Percentage of Participants With Breast Cancer Phenotypes Among Different Hispanic Countries
Periodo de tiempo: Baseline up to 30 months
|
Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.
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Baseline up to 30 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2011
Finalización primaria (Actual)
1 de diciembre de 2013
Finalización del estudio (Actual)
1 de diciembre de 2013
Fechas de registro del estudio
Enviado por primera vez
26 de agosto de 2015
Primero enviado que cumplió con los criterios de control de calidad
26 de agosto de 2015
Publicado por primera vez (Estimar)
28 de agosto de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de abril de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
24 de febrero de 2017
Última verificación
1 de febrero de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ML25371
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. .
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