NCT03068663

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
42mo left

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
May 2017Oct 2029

First Submitted

Initial submission to the registry

February 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

May 23, 2017

Completed
12.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2029

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

12.4 years

First QC Date

February 27, 2017

Last Update Submit

March 18, 2026

Conditions

Non Small Cell Lung Cancer

Keywords

lung cancerintestinal microbiotalung microbiotasurgerychemotherapy

Outcome Measures

Primary Outcomes (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).

    1.5 - 4.5 months

Secondary Outcomes (3)

  • Effect of chemotherapy on microbiota (by comparing before and after chemotherapy)

    3.5-4.5 months

  • inflammatory status

    1.5 - 4.5 months

  • effect of microbiota on pulmunary immune cells

    1.5 - 4.5 months

Study Arms (2)

Pchir

EXPERIMENTAL

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

Pct-chir

EXPERIMENTAL

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

Interventions

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.

PchirPct-chir

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • non small cell lung carcinoma patient suitable for surgery, or chemotherapy followed by surgery
  • BMI \<29.9 kg/m²
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Jean Perrin

Clermont-Ferrand, Puy de dôme, 63003, France

Location

Related Publications (2)

  • 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.

    PMID: 26147207BACKGROUND

  • 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.

    PMID: 32450847DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • 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

    STUDY DIRECTOR

  • Marc Filaire, MD, Pr

    Service de Chirurgie Thoracique, Centre Jean Perrin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2017

First Posted

March 3, 2017

Study Start

May 23, 2017

Primary Completion (Estimated)

October 30, 2029

Study Completion (Estimated)

October 30, 2029

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)