NCT04604522 Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome
| NCT ID | NCT04604522 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Bronchiolitis Obliterans |
| Study Type | OBSERVATIONAL |
| Enrollment | 15 participants |
| Start Date | 2020-08-27 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15 participants in total. It began in 2020-08-27 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study investigates a type of cell, called abnormal clonogenic epithelial cells, in patients with bronchiolitis obliterans syndrome who have had an donor stem cell transplant or a lung transplant. Learning more about clonogenic cells in these patients may help doctors to detect signs of bronchiolitis obliterans syndrome earlier in future patients.
Eligibility Criteria
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
Contact & Investigator
Ajay Sheshadri
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT04604522 clinical trial?
This trial is open to participants of all sexes, studying Bronchiolitis Obliterans. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04604522 currently recruiting?
Yes, NCT04604522 is actively recruiting participants. Contact the research team at asheshadri@mdanderson.org for enrollment information.
Where is the NCT04604522 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT04604522 clinical trial?
NCT04604522 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Ajay Sheshadri at M.D. Anderson Cancer Center. The trial plans to enroll 15 participants.