Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome

Обзор

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.

Подробное описание

PRIMARY OBJECTIVE:

I. To characterize epithelial cell phenotypes in allogeneic hematopoietic cell transplant (allo-HCT) recipients at MD Anderson Cancer Center (MDACC) and in lung transplant recipients at Houston Methodist who have bronchiolitis obliterans syndrome (BOS).

OUTLINE:

Patients undergo collection of blood samples and 3 brushings of the airway during standard of care (SOC) bronchoscopy. After the bronchoscopy, patients undergo 2 nasal brushings (swabs). Patients' medical records are also reviewed for data collection.

After completion of study, patients are followed for up to 1 year.

Вмешательства

• Процедура Biospecimen Collection
  Undergo collection of blood, airway brushings.
• Другое Medical Chart Review
  Patients' medical records are reviewed

Первичные конечные точки

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

Вторичные конечные точки (1)

• Comparison of epithelial cell populations in allogeneic hematopoietic cell transplant recipients and lung graft recipients [Срок оценки: Up to 1 year]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• Bronchoscopy performed on emergency basis for life-threatening issues as opposed to routine diagnostic testing
• Patient unwilling to give consent for study airway brushings

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• M D Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT04604522 · 2020-0325 · NCI-2020-07790 · 2020-0325 · K23AI117024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗