- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00899782
Collection and Storage of Blood and Tissue Samples From Patients Who Are Undergoing Surgery For Lung Cancer
The CALGB Lung Cancer Tissue Bank
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- To collect, catalog and store frozen samples of lung carcinoma and when possible, portions of involved lymph nodes, as well as adjacent grossly uninvolved lung tissue obtained from surgical specimens of patients undergoing surgical resection for previously untreated lung cancer as a source of quality DNA, messenger ribonucleic acid (mRNA) and protein for molecular analysis.
- To collect, catalog and store frozen samples of blood pre- and post-resection from the same patients to provide a source of reference DNA to assess somatic mutations associated with tumor or preneoplastic "normal" lung, and to allow assessment of levels of circulating markers.
- To associate these specimens with historical, clinical, pathological, and outcome information.
Grossly viable tumor and grossly normal lung tissue are identified and removed from patient surgical specimens and cryopreserved until shipment to the Cancer and Leukemia Group B (CALGB) Lung Cancer Tissue Bank for future use in research. Blood specimens are also collected prior to surgery and at 4-12 weeks post-surgery (before the start of adjuvant therapy) and shipped immediately to the Tissue Bank.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Delaware
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Lewes, Delaware, Estados Unidos, 19958
- Tunnell Cancer Center at Beebe Medical Center
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Newark, Delaware, Estados Unidos, 19713
- CCOP - Christiana Care Health Services
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Maryland
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Elkton, Maryland, Estados Unidos, 21921
- Union Hospital of Cecil County
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Dana-Farber/Brigham and Women's Cancer Center
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Boston, Massachusetts, Estados Unidos, 02115
- Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- Masonic Cancer Center at University of Minnesota
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Missouri
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Columbia, Missouri, Estados Unidos, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Saint Louis, Missouri, Estados Unidos, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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New Jersey
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Voorhees, New Jersey, Estados Unidos, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
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New York
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Buffalo, New York, Estados Unidos, 14263-0001
- Roswell Park Cancer Institute
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Syracuse, New York, Estados Unidos, 13210
- SUNY Upstate Medical University Hospital
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North Carolina
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Asheville, North Carolina, Estados Unidos, 28805
- Veterans Affairs Medical Center - Asheville
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Durham, North Carolina, Estados Unidos, 27710
- Duke Cancer Institute
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Pennsylvania
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Monroeville, Pennsylvania, Estados Unidos, 15146
- Forbes Regional Hospital
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Natrona Heights, Pennsylvania, Estados Unidos, 15065
- Alle-Kiski Medical Center
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Pittsburgh, Pennsylvania, Estados Unidos, 15212
- Allegheny Cancer Center at Allegheny General Hospital
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02906
- Miriam Hospital
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Providence, Rhode Island, Estados Unidos, 02903
- Rhode Island Hospital Comprehensive Cancer Center
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Vermont
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Burlington, Vermont, Estados Unidos, 05401
- Fletcher Allen Health Care - University Health Center Campus
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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
- Histologic Documentation: All patients with suspected or histologically documented previously untreated lung cancer undergoing surgical resection are eligible whether or not the patient participates in a CALGB-sponsored treatment trial; patients enrolled on a CALGB trial of preoperative chemotherapy for lung cancer will be eligible if a pre-treatment frozen sample of tumor (e.g., a positive lymph node from mediastinoscopy) can be submitted to the bank; patients enrolled on CALGB 140203, intraoperative sentinel node mapping in non-small cell lung cancer, are not eligible.
- No patients with known infectious disease, such as human immunodeficiency virus (HIV), tuberculosis (TB), or hepatitis B, C
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Solo caso
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Ancillary-Correlative (lung cancer tissue bank)
Grossly viable tumor and grossly normal lung tissue are identified and removed from patient surgical specimens and cryopreserved until shipment to the CALGB Lung Cancer Tissue Bank for future use in research.
Blood specimens are also collected prior to surgery and at 4-12 weeks post-surgery (before the start of adjuvant therapy) and shipped immediately to the Tissue Bank.
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correlative studies
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Collection and storage of frozen tissue samples for molecular analysisor resection of lung cancer
Periodo de tiempo: Up to 5 years
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Up to 5 years
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Collection and storage of frozen blood samples for the assessment of somatic mutations and levels of circulating markersto assess levels of circulating markers
Periodo de tiempo: Up to 5 years
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Up to 5 years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: William Richards, MD, Brigham and Women's Cancer Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
- CALGB-140202
- U10CA180821 (Subvención/contrato del NIH de EE. UU.)
- U10CA031946 (Subvención/contrato del NIH de EE. UU.)
- CDR0000271323 (Identificador de registro: NCI Physician Data Query)
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