Toxicity of Treatments for Non-tuberculous Mycobacterial Infections in Cancer Patients or Not (NCT05030701) | Clinical Trial Compass
CompletedNot Applicable
Toxicity of Treatments for Non-tuberculous Mycobacterial Infections in Cancer Patients or Not
France41 participantsStarted 2021-04-09
Plain-language summary
Non-tuberculous mycobacteria (NTM) are increasingly common and have a poor prognosis: 5-year mortality can reach 40 to 50%, depending on the type of mycobacteria and the immune system of the host involved. Cancer patients are at higher risk of infectious morbidity and mortality, which may be due to disease-related immune dysfunction, immunosuppressive effects of chemotherapy, or long-term placement of a vascular catheter. However, data on the treatment of NTM species that cause infections and the disease characteristics of these pathogens in cancer patients are limited despite the growing cancer population worldwide. Recently, M. avium infections have been described in patients suffering from cancers (hematological or not), in particular in patients receiving checkpoint inhibitors. Although the proportion of M. avium pneumonia in retrospective series is low (0.8-2%), it has been shown that this population is younger, suffers less from sub-pulmonary pathology. (indicating immunosuppression in these patients) but are therefore treated less than non-cancerous subjects.
This retrospective study in CHU Amiens is searching on the number of side effects of NTM treatment in two groups (cancerous and no cancerous) to assess the cause of the decrease of NTM treatment in cancerous patients.
Who can participate
Age range
18 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:
* Age equal or more than 18 years18
* Patients diagnosed by an infection with non-tuberculous mycobacteria according to ATS guidelines.
* Patients received the NTM treatment.
Exclusion Criteria:
* age less than 18 years
* Patients diagnosed by NTM without treatment.
* Patients with a positive sample of NTM but without infection.
* Exclusion of other disorders such as tuberculous.
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.
1This study compared side effects of non-tuberculous mycobacterial treatment between cancer patients and non-cancer patients — based on what was found, does my specific cancer situation put me at higher risk for serious side effects from NTM treatment?
2Since this trial has already been completed, has my doctor seen or reviewed any of its findings, and how might those results influence the treatment plan they're recommending for me?
3The study focused on variation in the number of side effects between the two groups — does the data suggest that cancer patients experienced significantly more or different side effects than non-cancer patients, and what does that mean for how closely I'd need to be monitored?
4Are there particular NTM medications that showed a notably worse side effect profile in cancer patients in this study, and should that steer us toward or away from any specific treatment options in my case?
5Given that this was an observational study rather than a treatment trial, should I also be asking about separate clinical trials that are actually testing new or safer NTM treatments specifically for people with cancer?
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
variation of side effects number of non-tuberculous mycobacteria treatment between cancerous and non cancerous patient groups.