NCT02897401|Unknown
Determination of Carcinogens Nicotine in Electronic Cigarettes Users
CANICE
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CANICE
Sponsor study identifier
interventional
80
1 country
1
Study Start
September 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Multicenter, national study, non-randomized , controlled, comparative with 4 independent groups (20 participants in each group). There are 3 experimental groups ("smocker", "nicotine replacement therapy" an "electronic cigarette") and 1 control group ("without nicotine"). The main objective of the study is to compare the level of urinary NNN in the electronic cigarette users versus the nicotine replacement therapy (patch) users.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2016
Date type not reportedThis date has not been verified as actual or estimated.
September 7, 2016
Actual (reported)September 13, 2016
Actual (reported)November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
NNN urinary concentrations obtained in the group "electronic cigarette" versus group "nocotine replacement treatment".
The determination of urinary NNN of will be performed at the end of the study only for subjects with cotinine / creatinine ratio adequate.
At the inclusion
NNN urinary concentrations obtained in the group "electronic cigarette" versus group "smocker"
At the inclusion
NNN urinary concentrations obtained in the group "electronic cigarette" versus group "no consumption of nicotine"
At the inclusion
NNN urinary concentrations obtained in the group "nicotine replacement treatment" versus group "smocker"
At the inclusion
NNN urinary concentrations obtained in the group "nicotine replacement treatment" versus "no consumption of nicotine"
At the inclusion
Cigarette consumption in the context of their habit (not related to the particiapion under study).
Electronic cigarette consumption in the context of their habit (not related to the particiapion under study).
Collection of 5 mL of urinary sample.The pregnancy test is done in each investigator center.
APHP, Paul Brousse Hospital
Villejuif, 94800, France
Patrick Dupont, MD
APHP, Paul Brousse Hospital
First Submitted
September 7, 2016
First Posted
September 13, 2016
Study Start
September 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2017
Estimated (date passed)Nicotine replacement therapy (only patch) consumption in the context of their habit (not related to the particiapion under study).
No consumption in the context of their habit (not related to the particiapion under study).
Collection of 10 mL of urinary sample for cotinine analysis. The analysis is maid during the study and is centralised at the hospital Paul Brousse.
Collection of 20 mL of urinary sample for NNN analysis. The analysis is maid at the end of the study and is centralised in a laboratory located at Strasbourg.
This questionnaire will permit to assess the smoking habits of the participants.
This test will permit to determinate if the participant are axposed to passive smoking or not.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 13, 2016
Record last verified: 2016-08
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Source: ClinicalTrials.gov.
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