Low-dose Computed Tomography Screening for Lung Cancer in Relatives With Family History of Lung Cancer

Lung Cancer Clinical Trial

Official title:

Low-dose Computed Tomography Screening for Lung Cancer in Relatives With Family History of Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519972
• Other study ID #: DOH96-TD-G-111-016
• Status: Completed
• Phase: N/A
• First received: July 31, 2015
• Last updated: August 6, 2015
• Start date: August 2007
• Est. completion date: March 2011

Study information

• Verified date: August 2015
• Source: Taichung Veterans General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

Screening with the use of low-dose computed tomography (LDCT) reduces mortality from lung cancer. Relatives with family history of lung cancer are at increased risk of lung cancer compared to those without a family history in pooled analysis. A prospective trial using LDCT of lung to screen the relatives with family history of lung cancer is needed.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1102
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 75 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Device:
• low dose computed tomography
Participants will receive 3 round of low dose computed tomography screening every year

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital	Ministry of Health and Welfare, Taiwan

References & Publications (11)

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. — View Citation

Coté ML, Liu M, Bonassi S, Neri M, Schwartz AG, Christiani DC, Spitz MR, Muscat JE, Rennert G, Aben KK, Andrew AS, Bencko V, Bickeböller 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, Müeller H, Orlow I, Park BJ, Pinchev M, Raji OY, Rennert HS, Rudnai P, Seow A, Stucker I, Szeszenia-Dabrowska N, Dawn Teare M, Tjønnelan 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. — View Citation

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. Erratum in: N Engl J Med. 2008 Apr 24;358(17):1875. N Engl J Med. 2008 Apr 24;358(17):1862. N Engl J Med. 2008 Aug 21;359(8):877. — View Citation

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. Epub 2008 Dec 9. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Sun S, Schiller JH, Gazdar AF. Lung cancer in never smokers--a different disease. Nat Rev Cancer. 2007 Oct;7(10):778-90. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with lung cancer detected by low dose computed tomography		three years	No
Secondary	Detection rate of early lung cancer		three years	No