Microbiota and the Lung Cancer (MICA)

March 18, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
    • Puy de dôme
      • Clermont-Ferrand, Puy de dôme, France, 63003
        • Centre Jean Perrin

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Jean Perrin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Université d'Auvergne
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
GREENTECH SA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 23, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

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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