Microbiota and the Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

— MICA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03068663
• Other study ID #: 2016-A01640-51
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2017
• Est. completion date: October 30, 2029

Study information

• Verified date: May 2024
• Source: Centre Jean Perrin
• Contact: Marc Filaire, MD, Pr
• Phone: 0473278121
• Email: marc.filaire[@]clermont.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 30, 2029
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
France	Centre Jean Perrin	Clermont Ferrand	Cedex 1

Sponsors (4)

Lead Sponsor	Collaborator
Centre Jean Perrin	GREENTECH SA, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Université d'Auvergne

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1.5 - 4.5 months
Secondary	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.	3.5-4.5 months
Secondary	inflammatory status	dosage of plasmatic cytokines and interleukins (ELISA or luminex)	1.5 - 4.5 months
Secondary	effect of microbiota on pulmunary immune cells	characterization of immune cells on lung/tumor sample and bronchoalveolar lavage fluid (flow cytometry and/or immunohistochemistry)	1.5 - 4.5 months