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Non Small Cell Lung CancerMICANCT03068663

Microbiota and the Lung Cancer

A study testing Sampling in people with Non Small Cell Lung Cancer, run by Centre Jean Perrin at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Sampling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteFrance
Study dates
23 May 2017to 30 Oct 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Jean Perrin

    Clermont-Ferrand, Puy de dôme, 63003

Other trials in France

About this study

Official title: 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.

Read the 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).

Being tested
Sampling
Keywords
lung cancer, intestinal microbiota, lung microbiota, surgery, chemotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SamplingOther

    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.

Study groups in NCT03068663
Study groupRoleWhat they receive
PchirExperimentalNon 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
Receives: Other: Sampling
Pct-chirExperimentalNon 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
Receives: Other: Sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 1.5 - 4.5 months

Secondary outcomes (3)

  1. 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.

    Measured: 3.5-4.5 months

  2. inflammatory status

    dosage of plasmatic cytokines and interleukins (ELISA or luminex)

    Measured: 1.5 - 4.5 months

  3. effect of microbiota on pulmunary immune cells

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

    Measured: 1.5 - 4.5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2017
  2. Study start23 May 2017
  3. Primary completion30 Oct 2029 (estimated)
  4. Study completion30 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03068663
Sponsor's protocol ID
2016-A01640-51
Acronym
MICA
Status last verified
Mar 2026
First submitted
27 Feb 2017
Last updated
20 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26147207

  • 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.

    PubMed 32450847

Questions about this trial

What is this clinical trial studying?

A study testing Sampling in people with Non Small Cell Lung Cancer, run by Centre Jean Perrin at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in diversity of the lungs and upper airways microbiota (time frame: 1.5 - 4.5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03068663, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.

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