NCT05119244

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Oct 2021Feb 2027

Study Start

First participant enrolled

October 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Expected
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

November 2, 2021

Last Update Submit

April 30, 2026

Conditions

Keywords

Cannabis, Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • percentage of patients who are active or not active cannabis smokers (at least 10 joints per for at least one year).

    1 year

Study Arms (3)

cannabis smokers

EXPERIMENTAL
Other: blood and hair sampling

Tobacco smokers

EXPERIMENTAL
Other: blood and hair sampling

Non-smoking patients

EXPERIMENTAL
Other: blood and hair sampling

Interventions

3.5 ml blood sample Hair sample

Non-smoking patientsTobacco smokerscannabis smokers

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Patient denied participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, 92350, France

RECRUITING

Hopital Paris Saint Joseph

Paris, 75014, France

COMPLETED

Institut Gustave Roussy

Villejuif, France

COMPLETED

MeSH Terms

Conditions

Marijuana AbuseLung Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Pauline PRADERE, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2021

First Posted

November 15, 2021

Study Start

October 1, 2021

Primary Completion

October 1, 2022

Study Completion (Estimated)

February 1, 2027

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations