Tiny lung cells may hold key to early detection of deadly transplant complication
NCT ID NCT04604522
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at abnormal cells in the lungs of 15 people who developed bronchiolitis obliterans syndrome after a stem cell or lung transplant. Researchers want to understand these cells better so doctors can spot the disease earlier in future patients. Participants will have extra brushings during a routine bronchoscopy to collect cell samples.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2020
- Expected to finish
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Mar 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with BOS who have undergone an allo-HCT or lung allograft.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Allo-HCT recipients undergoing a bronchoscopy at MDACC who consent to undergoing study airway brushings in addition to clinically indicated bronchoscopic procedures (e.g. bronchoalveolar lavage) * 5 patients with advanced BOS - forced expiratory volume in one second (FEV1) =\< 75% predicted and meeting other National Institutes of Health (NIH) criteria (FEV1/forced vital capacity \[FVC\] ratio 0.7, presence of air trapping or graft versus host disease \[GVHD\] of another organ) * 5 patient with early BOS - at least 10% decline in FEV1 from baseline values, with FEV1 \>= 75% predicted, and 1 high-risk feature: * Active systemic chronic GVHD with new early airflow obstruction OR * Respiratory viral infection in last three months with resolution of viral symptoms but new airflow obstruction * 3 patients with no pulmonary impairment (FEV1 within 5% of baseline values) * Lung allograft recipients undergoing a bronchoscopy at Houston Methodist who consent to undergoing study airway brushing sin addition to clinically indicated bronchoscopy procedures * 5 patients with BOS Stage 2 or higher (\>= 35% decline in FEV1 from baseline values) * 5 patient with BOS Stage 0p or 1 (10-35% decline in FEV1 from baseline values) * 3 patients undergoing screening bronchoscopy without decline in FEV1 * patients with undiagnosed lung cancer and chronic obstructive pulmonary disease diagnosed by pulmonary function testing (FEV1/FVC less than the lower limit of normal with \>20 pack-year history of smoking) Exclusion Criteria: * Bronchoscopy performed on emergency basis for life-threatening issues as opposed to routine diagnostic testing * Patient unwilling to give consent for study airway brushings
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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M D Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New study aims to detect lung damage earlier in young transplant patients
- Can lung MRI replace CT scans for detecting a serious Post-Transplant lung condition?
- Inhaled drug aims to save transplanted lungs from silent threat
- New hope for lung scarring after transplant: belumosudil trial launches
- Inhaled cyclosporine aims to halt lung transplant rejection