Environment and Lung Cancer (PPE)
Primary Purpose
Cannabis Use
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood and hair sampling
Sponsored by
About this trial
This is an interventional health services research trial for Cannabis Use focused on measuring Cannabis, Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Any patient from 18 y.o to 59 y.o treated in one of the three above-mentioned hospitals for primary lung cancer, whatever its stage, and agreeing to participate in this research.
Exclusion Criteria:
- Patient denied participation.
Sites / Locations
- Centre Chirurgical Marie LannelongueRecruiting
- Institut Gustave Roussy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
cannabis smokers
Tobacco smokers
Non-smoking patients
Arm Description
Outcomes
Primary Outcome Measures
percentage of patients who are active or not active cannabis smokers (at least 10 joints per for at least one year).
Secondary Outcome Measures
Full Information
NCT ID
NCT05119244
First Posted
November 2, 2021
Last Updated
November 2, 2021
Sponsor
Centre Chirurgical Marie Lannelongue
1. Study Identification
Unique Protocol Identification Number
NCT05119244
Brief Title
Environment and Lung Cancer
Acronym
PPE
Official Title
Environment and Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Chirurgical Marie Lannelongue
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cannabis is the most consumed drug in the world and the French are the main consumers in Europe. The most recognized effects of cannabis on human health are of a neuro-psychic nature. The medical literature on the effects of cannabis on the lung in general, and on lung carcinogenesis in particular, is most often reassuring (Tashkin, Chest 2018; Zhang, Int J Cancer 2015; Ghasemiesfe JAMA Netw. Open. 2019), despite the fact that the concentration of carcinogens in cannabis smoke is higher than that contained in tobacco smoke (Moir, Chem. Res. Toxicol. 2008), and that cannabis smoking has been implicated in the occurrence of ENT cancers. Rather, research focuses on the therapeutic effects of cannabis, especially analgesics, and even on its possible anti-tumor virtues (Abrams, Jama Oncol. 2020). These reassuring data should, however, be viewed with a great deal of caution. On the one hand, the illegal nature of cannabis in most countries and its frequent association with tobacco consumption make studies on the subject difficult and often biased. On the other hand, the daily practice of oncologists, who observe numerous cases of advanced and rapidly progressive lung cancer occurring in young patients who are heavy users of cannabis, raises suspicion of an unrecognized role of cannabis in lung carcinogenesis.
In a preliminary multicenter study on French patients under 50 years of age operated for primary lung cancer (Betser, ERJ 2021), we demonstrated that cannabis consumption was extremely frequent, concerning 43% of patients, but mentioned in patients' medical records only in 4 out of 10 cases, while the smoking status was always noted.
In addition, by comparing people who smoke cannabis (always here associated with tobacco) to patients who only smoke tobacco or to non-smokers, we identified a different profile of lung cancers, with more poorly differentiated tumors, presenting at a more advanced stage (more T3-T4 versus T1-T2) requiring more complex surgery, and mostly located in the upper lobes of the lung.
Similar research work is currently underway at Gustave Roussy (Dr Pradere-Dr Planchard, Villejuif, France) on patients with metastatic lung cancer, with a focus on overall survival and molecular profile.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use
Keywords
Cannabis, Lung Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cannabis smokers
Arm Type
Experimental
Arm Title
Tobacco smokers
Arm Type
Experimental
Arm Title
Non-smoking patients
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
blood and hair sampling
Intervention Description
3.5 ml blood sample Hair sample
Primary Outcome Measure Information:
Title
percentage of patients who are active or not active cannabis smokers (at least 10 joints per for at least one year).
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any patient from 18 y.o to 59 y.o treated in one of the three above-mentioned hospitals for primary lung cancer, whatever its stage, and agreeing to participate in this research.
Exclusion Criteria:
Patient denied participation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pauline PRADERE, MD
Phone
01.40.94.22.79
Email
p.pradere@ghpsj.fr
Facility Information:
Facility Name
Centre Chirurgical Marie Lannelongue
City
Le Plessis Robinson
ZIP/Postal Code
92350
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mihaela Aldea, MD
12. IPD Sharing Statement
Learn more about this trial
Environment and Lung Cancer
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