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Microbiota and the Lung Cancer (MICA)

Primary Purpose

Non Small Cell Lung Cancer

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Sampling

About this trial

This is an interventional other trial for Non Small Cell Lung Cancer focused on measuring lung cancer, intestinal microbiota, lung microbiota, surgery, chemotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Jean PerrinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Pchir

Pct-chir

Arm Description

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

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

Outcomes

Primary Outcome Measures

Difference in diversity of the lungs and upper airways microbiota

The analysis of the diversity will be performed by DNA sequencing and qPCR on the different samples (saliva, bronchoalveolar lavage and lung tissue fragments).

Secondary Outcome Measures

Effect of chemotherapy on microbiota (by comparing before and after chemotherapy)

Difference in the proportion of the Firmicutes phylum between UAs and lungs, and difference in the proportion of most abundant bacterial phyla between three types of samples (saliva, lung tissue, faecal samples), all analysed by qPCR and sequencing.

inflammatory status

dosage of plasmatic cytokines and interleukins (ELISA or luminex)

effect of microbiota on pulmunary immune cells

characterization of immune cells on lung/tumor sample and bronchoalveolar lavage fluid (flow cytometry and/or immunohistochemistry)

Full Information

NCT ID

NCT03068663

First Posted

February 27, 2017

Last Updated

February 17, 2023

Sponsor

Centre Jean Perrin

Collaborators

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Université d'Auvergne, GREENTECH SA

1. Study Identification

Unique Protocol Identification Number

NCT03068663

Brief Title

Microbiota and the Lung Cancer

Acronym

MICA

Official Title

Characterization of Microbiota (Intestinal, From Lungs, and Upper Airways) in Patients With Non-small Cell Lung Carcinoma: Exploratory Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 23, 2017 (Actual)

Primary Completion Date

October 30, 2024 (Anticipated)

Study Completion Date

October 30, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Jean Perrin

Collaborators

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Université d'Auvergne, GREENTECH SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer

Keywords

lung cancer, intestinal microbiota, lung microbiota, surgery, chemotherapy

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pchir

Arm Type

Experimental

Arm Description

Arm Title

Pct-chir

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Sampling

Intervention Description

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.

Primary Outcome Measure Information:

Title

Difference in diversity of the lungs and upper airways microbiota

Description

The analysis of the diversity will be performed by DNA sequencing and qPCR on the different samples (saliva, bronchoalveolar lavage and lung tissue fragments).

Time Frame

1.5 - 4.5 months

Secondary Outcome Measure Information:

Title

Effect of chemotherapy on microbiota (by comparing before and after chemotherapy)

Description

Time Frame

3.5-4.5 months

Title

inflammatory status

Description

dosage of plasmatic cytokines and interleukins (ELISA or luminex)

Time Frame

1.5 - 4.5 months

Title

effect of microbiota on pulmunary immune cells

Description

characterization of immune cells on lung/tumor sample and bronchoalveolar lavage fluid (flow cytometry and/or immunohistochemistry)

Time Frame

1.5 - 4.5 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marc Filaire, MD, Pr

Phone

0473278121

marc.filaire@clermont.unicancer.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marie-Paule Vasson, Pr

Organizational Affiliation

Equipe ECREIN, CLARA, CRNH Auvergne; INRA, UMR 1019.

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Edith Filaire, Pr

Organizational Affiliation

CIAMS, Université Paris-Sud, Université Paris-Saclay, Université Orléans

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Annick Bernalier-Donadille, Dr

Organizational Affiliation

Equipe MINHOS, UR 454 Microbiologie, INRA

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Rea Bingula, Ph.D.

Organizational Affiliation

Equipe ECREIN, CLARA, CRNH Auvergne; INRA, UMR 1019

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Marc Filaire, MD, Pr

Organizational Affiliation

Service de Chirurgie Thoracique, Centre Jean Perrin

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Jean Perrin

City

Clermont Ferrand

State/Province

Cedex 1

ZIP/Postal Code

63003

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marc Filaire, Professor

Phone

0473278121

marc.filaire@clermont.unicancer.fr

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26147207

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.

Results Reference

background

PubMed Identifier

32450847

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.

Results Reference

derived

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Microbiota and the Lung Cancer

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