RECRUITING

Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome

Quick Facts

Study Start:2020-08-27

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04604522

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Ajay Sheshadri

CONTACT

713-792-6238

asheshadri@mdanderson.org

Principal Investigator

Ajay Sheshadri

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Ajay Sheshadri, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-27

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2020-08-27

Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

Bronchiolitis Obliterans