Calendario›BIAF›Collection of Sputum and Labeling for Lung Cancer
Collection of Sputum and Labeling for Lung Cancer
Ensayo de bioAffinity Technologies, Inc. en Cancer de pulmon.
Más ensayos de: Cáncer de pulmón.
- Fase
- no aplica
- Estado
- Reclutando pacientes
- Participantes
- 500
- Centros
- 3
- Fin del objetivo primario
- dic 2025
Qué significa cada fase y cada estado.
Estudio observacional. Comenzó en mar 2018.
Qué mide
Identificacion de caracteristicas diferenciales (320 dias)
Qué se prueba
Se comparan resultados de un ensayo diagnóstico con los métodos habituales de detección de cáncer de pulmón, analizando muestras de esputo de participantes sanos, de alto riesgo y con cáncer.
Lo que dice el documentocompare Assay results to diagnoses determined by currently accepted standards for lung cancer detection. This will be accomplished by analysis of sputum samples from three cohorts including healthy Participants, high risk Participants, and cancer patient Participants using the Assay as developed in accordance with findings of bioAffinity protocol BA-001 to confirm assay results.
Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe primary objective of this study is to compare Assay results to diagnoses determined by currently accepted standards for lung cancer detection. This will be accomplished by analysis of sputum samples from three cohorts including healthy Participants, high risk Participants, and cancer patient Participants using the Assay as developed in accordance with findings of bioAffinity protocol BA-001 to confirm assay results. Adjustments will be made as necessary to finalize Assay design for clinical trials and commercialization. The secondary objective of this study is to determine optimum methods for collection of sputum samples. Three sputum collection methods used by high risk Participants will be compared. Individuals at high risk for lung cancer will be assigned to one of three sputum collection cohorts including (1) acapella® airway assist device under medical supervision to obtain a single sputum sample; (2) acapella® airway assist device to obtain a sputum sample over a three-day period, and (3) individuals who under medical supervision will collect a single sputum sample assisted by nebulization of between 0.9% to 10% hypertonic saline. Samples will be compared to determine the optimal collection method for sample analysis by CyPath® Lung.
Más ensayos de BIAF
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| BA-004 | Sin fase asignada | Reclutando pacientes | abr 2029 (prevista) |
| Detection of Abnormal Respiratory Cell Populations in Lung Cancer Screening Patients Using the CyPath Lung Assay | no aplica | Sin noticias del promotor | mar 2024 (prevista, ya pasada: sin actualizar en el registro) |
| Sputum Labeling Utilizing Synthetic Meso-Tetra (4-Carboxyphenyl) Porphyrin (TCPP) for Detection of Lung Cancer | no aplica | Completado | ago 2018 (real) |
| CyPath® | Sin fase asignada | Completado | abr 2015 (real) |
Todos los de BIAF, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03457415), actualizada en mar 2025.