Microbiota and the Lung Cancer (MICA)

February 17, 2023 updated by: Centre Jean Perrin

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: 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.
Experimental: 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
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in diversity of the lungs and upper airways microbiota
Time Frame: 1.5 - 4.5 months
The analysis of the diversity will be performed by DNA sequencing and qPCR on the different samples (saliva, bronchoalveolar lavage and lung tissue fragments).
1.5 - 4.5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of chemotherapy on microbiota (by comparing before and after chemotherapy)
Time Frame: 3.5-4.5 months
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.
3.5-4.5 months
inflammatory status
Time Frame: 1.5 - 4.5 months
dosage of plasmatic cytokines and interleukins (ELISA or luminex)
1.5 - 4.5 months
effect of microbiota on pulmunary immune cells
Time Frame: 1.5 - 4.5 months
characterization of immune cells on lung/tumor sample and bronchoalveolar lavage fluid (flow cytometry and/or immunohistochemistry)
1.5 - 4.5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Jean Perrin

Collaborators

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

Investigators

  • Study Director: Marie-Paule Vasson, Pr, Equipe ECREIN, CLARA, CRNH Auvergne; INRA, UMR 1019.
  • Study Director: Edith Filaire, Pr, CIAMS, Université Paris-Sud, Université Paris-Saclay, Université Orléans
  • Study Director: Annick Bernalier-Donadille, Dr, Equipe MINHOS, UR 454 Microbiologie, INRA
  • Study Director: Rea Bingula, Ph.D., Equipe ECREIN, CLARA, CRNH Auvergne; INRA, UMR 1019
  • Principal Investigator: Marc Filaire, MD, Pr, Service de Chirurgie Thoracique, Centre Jean Perrin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2017

Primary Completion (Anticipated)

October 30, 2024

Study Completion (Anticipated)

October 30, 2029

Study Registration Dates

First Submitted

February 27, 2017

First Submitted That Met QC Criteria

February 27, 2017

First Posted (Actual)

March 3, 2017

Study Record Updates

Last Update Posted (Estimate)

February 20, 2023

Last Update Submitted That Met QC Criteria

February 17, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A01640-51

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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