False/Negative Rate of Lung Percutaneous Needle Biopsy
Palabras clave
Abstracto
Descripción
We will review medical records to identify patients who underwent percutaneous needle biopsy of a lung mass between 5/1/01 and 10/30/04. If the pathology report indicates that the biopsy showed no evidence of malignancy, we will examine the medical record for a "gold standard" diagnosis of the lesion in question, including the pathology result from a surgical resection or a repeat biopsy, imaging follow-up demonstrating regression of the lesion or size stability for at least 2 years, or clinical follow-up for at least 2 years with no clinical evidence of malignant disease. If this information is not available in the University Hospital medical record, we will contact the patient to obtain consent for follow-up using external sources (physician records, imaging studies, pathology reports).
We will derive descriptive statistics (prevalence of malignancy, sensitivity, specificity, and false negative rates). The overall sample size will be ~500 patients who had PTNB of a lung mass within the study period. Approximately 80 are expected to have a biopsy result showing no evidence of malignancy, based on a retrospective review performed under an IRB exemption (87-04, letter dated 9/28/04). The expected proportion of cases with no evidence of malignancy is approximately 0.15. For a 95% confidence interval of 0.15+/-0.075 we will need follow-up information from 61 patients, considering that this is a descriptive study with a dichotomous variable. This gives us a margin for patients who will be lost to follow-up
fechas
Verificado por última vez: | 06/30/2016 |
Primero enviado: | 03/11/2008 |
Inscripción estimada enviada: | 03/11/2008 |
Publicado por primera vez: | 03/18/2008 |
Última actualización enviada: | 07/14/2016 |
Última actualización publicada: | 07/17/2016 |
Fecha de inicio real del estudio: | 05/31/2006 |
Fecha estimada de finalización primaria: | 02/28/2010 |
Fecha estimada de finalización del estudio: | 03/31/2010 |
Condición o enfermedad
Fase
Criterio de elegibilidad
Edades elegibles para estudiar | 18 Years A 18 Years |
Sexos elegibles para estudiar | All |
Método de muestreo | Non-Probability Sample |
Acepta voluntarios saludables | si |
Criterios | Inclusion Criteria: - subjects who underwent percutaneous needle biopsy of a lung mass during the study period of 5/1/01 to 10/30/04 Exclusion Criteria: - subjects will be excluded if at least one core sample was not obtained in the course of the biopsy. - subjects who had a pathology sample read as "insufficient for diagnosis" - subjects who underwent needle biopsy only for infection, to identify a causative organism |
Salir
Medidas de resultado primarias
1. The primary objective is to determine the false negative rate of PTNB procedures that include core tissue samples, and to compare it to the historical false negative rate of PTNB with FNA only. [2 years]
Medidas de resultado secundarias
1. To determine the sensitivity of PTNB procedures that include at least one core tissue sample, for the diagnosis of malignancy. [2 years]