Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03068663

Microbiota and the Lung Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Jean Perrin

Clermont-Ferrand, Puy de dôme, 63003, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sampling

Other

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 outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. inflammatory status

    Time frame: 1.5 - 4.5 months

    dosage of plasmatic cytokines and interleukins (ELISA or luminex)

  3. 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)

Sponsors and collaborators

Lead sponsor

Centre Jean Perrin

Other

Collaborators

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

Registry information

Official study title

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

Acronym: MICA

Important dates

Study start
2017
Primary completion
2029
Study completion
2029
First posted
Mar 3, 2017
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.