Clinical trial NCT03068663: Microbiota and the Lung Cancer
Official title: Characterization of Microbiota (intestinal, from Lungs, and Upper Airways) in Patients with Non-small Cell Lung Carcinoma: Exploratory Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non Small Cell Lung Cancer
Keywords: lung cancer
intestinal microbiota
lung microbiota
surgery
chemotherapy
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
name: Université d'Auvergne
name: GREENTECH SA
First posted: 2017-03-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups of patients will be follow :

* Pchir : Non small cell lung carcinoma patients with an indication of immediate surgery.
* Pct-chir : Non small cell lung carcinoma patients with an indication of neoadjuvant chemotherapy before the surgery.
Primary purpose: OTHER

Brief summary: The subject is to study the lung microbiota and the one of upper airways (UAs) (much less studied than the intestinal microbiota) in 40 patients having lung cancer. 20 patients undergo only surgical treatment, while other half receives also chemotherapy. The idea is to explore changes in microbiota of the lung, upper UAs and intestine, and potentially find associations between them. These results will serve us as a base for the future study, focused on manipulation of the microbiota by prebiotics, probiotics or symbiotics and its effect on anti-cancer treatment tolerance and effectiveness.

Detailed description: Lung cancer patients will be divided in two groups, a first one with patients undergoing both chemotherapy and surgery (Pct-chir), and the second one with patients only undergoing surgery (Pchir). Following inclusion, they will be given a 7-days alimentary survey, along with blood and saliva sampling (after buccodental examination and dental panoramic). The Pct-chir group will repeat the same procedure after the chemotherapy and before the surgery.

Day before the surgery, patients are asked to bring their faecal samples (in special box provided in advance) and the filled survey. During the operation the piece of lung tissue as well as the tumour (if the size enables it) will be sampled for further analysis. Lavage will be performed on the lung immediately after its resection.

Saliva, faecal sample, lung and tumour tissue, and lavage will be used for bacterial DNA extraction, followed by qPCR and sequencing analysis.

Lavage and blood samples will be analysed by flow cytometry and ELISA, to establish the immunological profile (interleukines, cell surface markers).

Eligibility criteria: Inclusion Criteria:

* non small cell lung carcinoma patient suitable for surgery, or chemotherapy followed by surgery
* BMI \<29.9 kg/m²
* not taking antibiotics, corticosteroids and/or immunosuppressants at least during two months before inclusion
* not taking prebiotics, probiotics or symbiotics at least during two months before inclusion
* signing the written consent before enrollment in the study
* affiliation to the national health insurance (or system alike) according to the law from 9th August 2004

Exclusion Criteria:

* cognitive difficulties
* refusal of participation or inability to give a clear consent
* digestive or pulmonary infection of a long duration during the two months preceding the study (with antibiotic treatment)
* inflammatory digestive pathology
* concurrent treatment with experimental medication, participation in another clinical therapeutic study within 30 days
* presence of colostomy, total or partial gastrectomy
* previous esophageal surgery
* previous ORL (otho-rhino-laryngo) cancer treated by radiotherapy or surgery
* patient enable to follow the requirements of the study
* patient deprived of his rights by administrative or judicial decision

Primary outcomes:
measure: Difference in diversity of the lungs and upper airways microbiota
timeFrame: 1.5 - 4.5 months
Secondary outcomes:
measure: Effect of chemotherapy on microbiota (by comparing before and after chemotherapy)
timeFrame: 3.5-4.5 months
measure: inflammatory status
timeFrame: 1.5 - 4.5 months
measure: effect of microbiota on pulmunary immune cells
timeFrame: 1.5 - 4.5 months
Other outcomes:
Locations:
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
state: Puy de Dôme
Study officials:
affiliation: Equipe ECREIN, CLARA, CRNH Auvergne; INRA, UMR 1019.
name: Marie-Paule Vasson, Pr
role: STUDY_DIRECTOR
affiliation: CIAMS, Université Paris-Sud, Université Paris-Saclay, Université Orléans
name: Edith Filaire, Pr
role: STUDY_DIRECTOR
affiliation: Equipe MINHOS, UR 454 Microbiologie, INRA
name: Annick Bernalier-Donadille, Dr
role: STUDY_DIRECTOR
affiliation: Equipe ECREIN, CLARA, CRNH Auvergne; INRA, UMR 1019
name: Rea Bingula, Ph.D.
role: STUDY_DIRECTOR
affiliation: Service de Chirurgie Thoracique, Centre Jean Perrin
name: Marc Filaire, MD, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Montassier E, Gastinne T, Vangay P, Al-Ghalith GA, Bruley des Varannes S, Massart S, Moreau P, Potel G, de La Cochetiere MF, Batard E, Knights D. Chemotherapy-driven dysbiosis in the intestinal microbiome. Aliment Pharmacol Ther. 2015 Sep;42(5):515-28. doi: 10.1111/apt.13302. Epub 2015 Jul 6.
citation: Bingula R, Filaire E, Molnar I, Delmas E, Berthon JY, Vasson MP, Bernalier-Donadille A, Filaire M. Characterisation of microbiota in saliva, bronchoalveolar lavage fluid, non-malignant, peritumoural and tumour tissue in non-small cell lung cancer patients: a cross-sectional clinical trial. Respir Res. 2020 May 25;21(1):129. doi: 10.1186/s12931-020-01392-2.