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Microbiota and the Lung Cancer (MICA)

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ClinicalTrials.gov Identifier: NCT03068663
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
Institut National de la Recherche Agronomique
Université d'Auvergne
GREENTECH SA
Information provided by (Responsible Party):
Centre Jean Perrin

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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Other: Sampling Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Characterization of Microbiota (Intestinal, From Lungs, and Upper Airways) in Patients With Non-small Cell Lung Carcinoma: Exploratory Study
Actual Study Start Date : May 23, 2017
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068663


Contacts
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Contact: Marc Filaire, MD, Pr 0473278121 marc.filaire@clermont.unicancer.fr

Locations
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France
Centre Jean Perrin Recruiting
Clermont Ferrand, Cedex 1, France, 63003
Contact: Marc Filaire, Professor    0473278121    marc.filaire@clermont.unicancer.fr   
Sponsors and Collaborators
Centre Jean Perrin
Institut National de la Recherche Agronomique
Université d'Auvergne
GREENTECH SA
Investigators
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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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Jean Perrin
ClinicalTrials.gov Identifier: NCT03068663    
Other Study ID Numbers: 2016-A01640-51
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Jean Perrin:
lung cancer
intestinal microbiota
lung microbiota
surgery
chemotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases