Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2017-05-23
2029-10-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
* 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.
OTHER
NONE
Study Groups
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Pchir
Non small cell lung carcinoma patients designated for immediate surgery. Intervention in this group is "sampling". The sampling will be done for:
* blood and saliva: at consultations after inclusion in the study
* faeces: day before the surgery
* lung/tumour tissue, bronchoalveolar lavage: during surgery after lobectomy
Sampling
Patients will receive their standard treatments, surgery with/without chemotherapy. A patient intervention consists in taking samples of blood, saliva, faeces, lung/tumour tissue, and bronchoalveolar lavage fluid.
Pct-chir
Non small cell lung carcinoma patients who will receive neoadjuvant chemotherapy before the surgery. Intervention in this group is "sampling". The sampling will be done for:
* blood and saliva: 1st time at consultations after inclusion in the study, 2nd time at consultations after chemotherapy and before surgery
* faeces: 1st time the day before the chemotherapy, 2nd time the day before the surgery
* lung/tumour tissue, bronchoalveolar lavage: during surgery after lobectomy
Sampling
Patients will receive their standard treatments, surgery with/without chemotherapy. A patient intervention consists in taking samples of blood, saliva, faeces, lung/tumour tissue, and bronchoalveolar lavage fluid.
Interventions
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Sampling
Patients will receive their standard treatments, surgery with/without chemotherapy. A patient intervention consists in taking samples of blood, saliva, faeces, lung/tumour tissue, and bronchoalveolar lavage fluid.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
OTHER
Université d'Auvergne
OTHER
GREENTECH SA
UNKNOWN
Centre Jean Perrin
OTHER
Responsible Party
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Principal Investigators
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Marie-Paule Vasson, Pr
Role: STUDY_DIRECTOR
Equipe ECREIN, CLARA, CRNH Auvergne; INRA, UMR 1019.
Edith Filaire, Pr
Role: STUDY_DIRECTOR
CIAMS, Université Paris-Sud, Université Paris-Saclay, Université Orléans
Annick Bernalier-Donadille, Dr
Role: STUDY_DIRECTOR
Equipe MINHOS, UR 454 Microbiologie, INRA
Rea Bingula, Ph.D.
Role: STUDY_DIRECTOR
Equipe ECREIN, CLARA, CRNH Auvergne; INRA, UMR 1019
Marc Filaire, MD, Pr
Role: PRINCIPAL_INVESTIGATOR
Service de Chirurgie Thoracique, Centre Jean Perrin
Locations
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Centre Jean Perrin
Clermont-Ferrand, puy de dôme, France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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2016-A01640-51
Identifier Type: -
Identifier Source: org_study_id
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