EARLY DETECTION OF SECOND PRIMARY LUNG CANCERS BY SPUTUM CYTOLOGY IMMUNOSTAINING
cytology specimen collection procedure
+ immunoenzyme technique
+ study of high risk factors
Neoplasias bronquiales+7
+ Carcinoma broncogénico
+ Enfermedades del pulmón
Estudio de Detección
Resumen
Fecha de inicio: 10 de octubre de 1995
Fecha en la que se inscribió al primer participante.OBJECTIVES: I. Evaluate whether immunostaining of induced sputum specimens improves the sensitivity and specificity of routine morphologic sputum surveillance to detect second primary lung cancer in patients with previously resected nonsmall cell lung cancer. II. Evaluate which patients are at risk of developing a second primary lung cancer by immunostaining specimens from patients with no morphologic atypia on routine Papanicolaou cytology. III. Make available archived sputum samples and bronchial washings for further analysis of new antibodies and techniques. IV. Evaluate whether analysis of elevations of relevant growth factors in bronchial lavage fluid from patients with positive immunostaining or morphologic atypia increases the accuracy of early detection. V. Evaluate whether quantitation of shed antigens in sputum increases the accuracy of early detection. VI. Evaluate whether the extent of airway obstruction, as measured by the forced expiratory volume, can predict an increased risk of developing lung cancer. OUTLINE: Screening for Second Primary Lung Cancer. Annual sputum induction for Papanicolaou cytology and immunostaining (using monoclonal antibodies 624H12 and 703D4), with optional pulmonary function tests and fiberoptic bronchoscopy with bronchial washings. PROJECTED ACCRUAL: 1,100 patients will be entered over 3 years. The sample size will be adjusted based on the rate of positive staining in the first 100 patients. Patients followed at uncertified centers are analyzed separately.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 1100 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Detección
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 120 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: Stage I (T1-2 N0) nonsmall cell lung cancer curatively resected and in regular follow-up for at least 6 weeks Material available for histologic review At least 1 mediastinal node station sampled or at least 2 years since surgery Any of the following histologies eligible: Squamous cell carcinoma Large cell carcinoma Adenocarcinoma (including bronchoalveolar) No small cell anaplastic component No recurrent disease or second primary No synchronous lung cancer of a different histology Concurrent registration on intergroup protocol I91-0001 allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Cardiovascular: No history of severe hypertension, i.e.: Systolic 200 mm Hg or more Diastolic 120 mm Hg or more No MI within 6 weeks Pulmonary: Available for annual sputum induction and clinical evaluation Clinically able to undergo pulmonary function tests (PFTs) and bronchoscopy Refusal of PFTs or bronchoscopy will not effect eligibility PFTs waived if FEV1/FVC < 65% on prior testing No acute respiratory infection Other: No prior uncontrolled malignancy except nonmelanomatous skin cancer Exceptions for malignancy controlled more than 5 years discretionary PRIOR CONCURRENT THERAPY: Complete surgical resection required as primary therapy At least 6 weeks since resection, any adjuvant chemotherapy or radiotherapy, or thoracoabdominal surgery
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 5 ubicaciones
H. Lee Moffitt Cancer Center and Research Institute
Tampa, United StatesAbrir H. Lee Moffitt Cancer Center and Research Institute en Google MapsCCOP - Iowa Oncology Research Association
Des Moines, United StatesCCOP - Northern New Jersey
Hackensack, United StatesIreland Cancer Center
Cleveland, United States