- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02519972
Low-dose Computed Tomography Screening for Lung Cancer in Relatives With Family History of Lung Cancer
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Investigators invited participants with family history to join in this study under the criteria of (1) relatives of the lung cancer patients; (2) age older than 55 years old or age older than the age of onset of lung cancer proband if the family members were less than 55 years old; (3) compulsory signing the consent agreement after understanding the purpose of study and the exposure of radiation. The participants with (1) proved lung cancer either with or without treatment, (2) presence of hemoptysis or history of remarkable lung fibrosis, (3) any other cancer history or (4) chest CT examination within one year would be excluded from the study.
The study was planned to enroll 1000 participants from simplex families and 500 participants from multiplex families for lung LDCT screening. Multiplex family was defined as two or more family members with lung cancers, and simplex family as one family member with lung cancer.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- relatives of the lung cancer patients;
- age older than 55 years old or age older than the age of onset of lung cancer proband if the family members were less than 55 years old;
- compulsory signing the consent agreement after understanding the purpose of study and the exposure of radiation.
Exclusion Criteria:
- proved lung cancer either with or without treatment,
- presence of hemoptysis or history of remarkable lung fibrosis,
- any other cancer history or
- chest CT examination within one year
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Low dose computed tomography
All the Low dose computed tomography of lung was performed with 64 slices multidetectors CT in single hold breath covering entire lung.
The protocol of scanning parameters (120KVp, 40-80 mA, 1.25 mm or less in thickness) was standardized.
The raw data would be reconstructed to axial images (3 mm thickness and interval) and coronal images (3 mm thickness and interval).
The scan should be finished in a single breath (15-20 second) from the thoracic inlet to adrenal glands.
|
Participants will receive 3 round of low dose computed tomography screening every year
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Number of participants with lung cancer detected by low dose computed tomography
Periodo de tiempo: three years
|
three years
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Detection rate of early lung cancer
Periodo de tiempo: three years
|
three years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Gee-Chen Chang, MD, PhD, Taichung Veterans General Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
- International Early Lung Cancer Action Program Investigators; Henschke CI, Yankelevitz DF, Libby DM, Pasmantier MW, Smith JP, Miettinen OS. Survival of patients with stage I lung cancer detected on CT screening. N Engl J Med. 2006 Oct 26;355(17):1763-71. doi: 10.1056/NEJMoa060476. Erratum In: N Engl J Med. 2008 Apr 24;358(17):1875. N Engl J Med. 2008 Aug 21;359(8):877. N Engl J Med. 2008 Apr 24;358(17):1862.
- Matakidou A, Eisen T, Houlston RS. Systematic review of the relationship between family history and lung cancer risk. Br J Cancer. 2005 Oct 3;93(7):825-33. doi: 10.1038/sj.bjc.6602769.
- Cote ML, Liu M, Bonassi S, Neri M, Schwartz AG, Christiani DC, Spitz MR, Muscat JE, Rennert G, Aben KK, Andrew AS, Bencko V, Bickeboller H, Boffetta P, Brennan P, Brenner H, Duell EJ, Fabianova E, Field JK, Foretova L, Friis S, Harris CC, Holcatova I, Hong YC, Isla D, Janout V, Kiemeney LA, Kiyohara C, Lan Q, Lazarus P, Lissowska J, Le Marchand L, Mates D, Matsuo K, Mayordomo JI, McLaughlin JR, Morgenstern H, Mueller H, Orlow I, Park BJ, Pinchev M, Raji OY, Rennert HS, Rudnai P, Seow A, Stucker I, Szeszenia-Dabrowska N, Dawn Teare M, Tjonnelan A, Ugolini D, van der Heijden HF, Wichmann E, Wiencke JK, Woll PJ, Yang P, Zaridze D, Zhang ZF, Etzel CJ, Hung RJ. Increased risk of lung cancer in individuals with a family history of the disease: a pooled analysis from the International Lung Cancer Consortium. Eur J Cancer. 2012 Sep;48(13):1957-68. doi: 10.1016/j.ejca.2012.01.038. Epub 2012 Mar 19.
- Sun S, Schiller JH, Gazdar AF. Lung cancer in never smokers--a different disease. Nat Rev Cancer. 2007 Oct;7(10):778-90. doi: 10.1038/nrc2190.
- Katanoda K, Marugame T, Saika K, Satoh H, Tajima K, Suzuki T, Tamakoshi A, Tsugane S, Sobue T. Population attributable fraction of mortality associated with tobacco smoking in Japan: a pooled analysis of three large-scale cohort studies. J Epidemiol. 2008;18(6):251-64. doi: 10.2188/jea.je2007429. Epub 2008 Dec 9.
- Chen CJ, Wu HY, Chuang YC, Chang AS, Luh KT, Chao HH, Chen KY, Chen SG, Lai GM, Huang HH, et al. Epidemiologic characteristics and multiple risk factors of lung cancer in Taiwan. Anticancer Res. 1990 Jul-Aug;10(4):971-6.
- Sone S, Takashima S, Li F, Yang Z, Honda T, Maruyama Y, Hasegawa M, Yamanda T, Kubo K, Hanamura K, Asakura K. Mass screening for lung cancer with mobile spiral computed tomography scanner. Lancet. 1998 Apr 25;351(9111):1242-5. doi: 10.1016/S0140-6736(97)08229-9.
- Sone S, Li F, Yang ZG, Honda T, Maruyama Y, Takashima S, Hasegawa M, Kawakami S, Kubo K, Haniuda M, Yamanda T. Results of three-year mass screening programme for lung cancer using mobile low-dose spiral computed tomography scanner. Br J Cancer. 2001 Jan 5;84(1):25-32. doi: 10.1054/bjoc.2000.1531.
- Nawa T, Nakagawa T, Kusano S, Kawasaki Y, Sugawara Y, Nakata H. Lung cancer screening using low-dose spiral CT: results of baseline and 1-year follow-up studies. Chest. 2002 Jul;122(1):15-20. doi: 10.1378/chest.122.1.15.
- New York Early Lung Cancer Action Project Investigators. CT Screening for lung cancer: diagnoses resulting from the New York Early Lung Cancer Action Project. Radiology. 2007 Apr;243(1):239-49. doi: 10.1148/radiol.2431060467.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
- DOH96-TD-G-111-016
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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