Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04604522

Conditions

Bronchiolitis Obliterans

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Medical Chart Review

Study Details

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.

Conditions

Bronchiolitis Obliterans

Study ID

NCT04604522

Start date

Aug 27, 2020

Status verified date

Mar, 2026

Completion date

Mar 31, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Arms

Ancillary-correlative (biospecimen collection, chart review)

Patients undergo collection of blood samples and 6 brushings of the airway during SOC bronchoscopy. Patients' medical records are also reviewed for data collection.

Interventions

Biospecimen Collection

Undergo collection of blood, airway brushings.

Medical Chart Review

Patients' medical records are reviewed

Primary outcome measure

  • Proportion of abnormal epithelial cells between patients with bronchiolitis obliterans syndrome and those without [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Ajay Sheshadri

713-792-6238asheshadri@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Ajay Sheshadri

713-792-6238

Principal Investigator:

Ajay Sheshadri

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-03-11.