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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04048954
Other study ID # WP-2019-01
Secondary ID NR1512030619
Status Completed
Phase
First received
Last updated
Start date May 30, 2019
Est. completion date June 1, 2020

Study information

Verified date August 2019
Source Weprom
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Smokers do not know the symptoms of cancer and wait on average 5 months with symptoms before consulting. 80% of lung cancers are diagnosed at too late and incurable stage. Systematic CT screening of smokers is under evaluation and currently not supported because expensive and little used in real life (in the US 1.8% of smokers after 7 years of establishment in the USA). An English study showed an increase in the number of operable stage cancers of 3% among smokers by calling them on a trailing cough by a simple poster campaign ("You smoke, you cough for more than 3 weeks, consult"). Regarding COPD, it is linked to tobacco in 85% of cases, affects 3.5 million French and is in 2013 the 4th leading cause of death in France. The evolution of COPD is marked by exacerbations, period of acute aggravation of symptoms, responsible for the deterioration of the quality of life or even hospitalization or death. COPD remains a silent killer responsible, according to this same summary review, of 16,500 deaths per year in France. Dr DENIS has developed a web application that has shown a 7-month survival benefit by early detection of lung cancer relapses based on the reporting of patient symptoms analyzed by a validated algorithm in 300 patients and 1 randomized trial. The Applitabac app takes this concept of symptom self-assessment by patients. By multiplying the number of symptoms analyzed compared to the English study, Applitabac should be able to increase the sensitivity of this early detection of COPD and increase the number of operable bronchial cancers and increase the chances of survival of patients.


Recruitment information / eligibility

Status Completed
Enrollment 5671
Est. completion date June 1, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age >= 18 years old - Applitabac user who has received a notification directing him to his doctor - Smoker or former smoker (current smoking cessation or = 5 years) - Patient informed of the use of his data and not opposing it Exclusion Criteria: - Presence of another evolutionary neoplasia in the past 2 years - Patient who did not use the Applitabac app

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Applitabac
Smartphone application in screening on tabagism complications

Locations

Country Name City State
France All MD Le Mans

Sponsors (3)

Lead Sponsor Collaborator
Weprom Department of Sarthe (72), Le Mans Town Hall (72)

Country where clinical trial is conducted

France, 

References & Publications (2)

Denis F, Basch E, Septans AL, Bennouna J, Urban T, Dueck AC, Letellier C. Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer. JAMA. 2019 Jan 22;321(3):306-307. doi: 10.1001/jama.2018.18085. — View Citation

Ironmonger L, Ohuma E, Ormiston-Smith N, Gildea C, Thomson CS, Peake MD. An evaluation of the impact of large-scale interventions to raise public awareness of a lung cancer symptom. Br J Cancer. 2015 Jan 6;112(1):207-16. doi: 10.1038/bjc.2014.596. Epub 20 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients fit for surgery for a symptomatic stage I-II lung cancer during the 12 weeks after the web-application rollout Proportion of patients fit for surgery for a symptomatic stage I-II lung cancer during the 12 weeks after the web-application rollout 12 weeks
Secondary Proportion of patients operated on for lung cancer during the first and second year of follow-up in comparaison of 2017/2018 Proportion of patients operated on for lung cancer during the first and second year of follow-up in comparaison of 2017/2018 first and second year of follow-up
Secondary Proportion of diagnosed lung cancers, by stage and total first and second year of follow-up Proportion of diagnosed lung cancers, by stage and total first and second year of follow-up first and second year of follow-up
Secondary Stage of lung cancer surgery with Applitabac first and second year of follow-up Stage of lung cancer surgery with Applitabac first and second year of follow-up first and second year of follow-up
Secondary Histological stage of diagnosed lung cancer Histological stage of diagnosed lung cancer second year of follow-up
Secondary Stages of other cancers of Applitabac users diagnosed with Applitabac in the first and second year of follow-up Stages of other cancers of Applitabac users diagnosed with Applitabac in the first and second year of follow-up first and second year of follow-up
Secondary Proportion of other cancers of Applitabac users diagnosed with Applitabac in the first and second year of follow-up Proportion of other cancers of Applitabac users diagnosed with Applitabac in the first and second year of follow-up first and second year of follow-up
Secondary Proportion of Applitabac-induced thoracic interventions without a cancer diagnosis first and second year of follow-up Proportion of Applitabac-induced thoracic interventions without a cancer diagnosis first and second year of follow-up first and second year of follow-up
Secondary Proportion of patients with another pathology detected by Applitabac in the first and second year of follow-up Proportion of patients with another pathology detected by Applitabac in the first and second year of follow-up first and second year of follow-up
Secondary Stage of diagnosis of COPD detected by the application (GOLD classification : VEMS) Stage of diagnosis of COPD detected by the application (GOLD classification : VEMS) second year of follow-up
Secondary Distribution of the stages of operated lung cancer, the two years preceding the implementation of Applitabac over similar periods Distribution of the stages of operated lung cancer, the two years preceding the implementation of Applitabac over similar periods Two years before use of Applitabac
Secondary Compare the distribution of the stages of operated patients (app vs. not app) Compare the distribution of the stages of operated patients (app vs. not app) second year of follow-up
Secondary Comparison of the stage distribution of patients operated before / after implementation of the application (via Epithor data base) Comparison of the stage distribution of patients operated before / after implementation of the application (via Epithor data base) second year of follow-up
Secondary Number of users who want to quit after first use Number of users who want to quit after first use 30 minutes after application implementation
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