Microbiota and the Lung Cancer (NCT03068663) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Microbiota and the Lung Cancer
France40 participantsStarted 2017-05-23
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in diversity of the lungs and upper airways microbiota