NCT04604522

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 27, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 27, 2020

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

5.6 years

First QC Date

October 21, 2020

Last Update Submit

March 9, 2026

Conditions

Bronchiolitis Obliterans

Outcome Measures

Primary Outcomes (1)

  • Proportion of abnormal epithelial cells between patients with bronchiolitis obliterans syndrome and those without

    The relationship between the proportion of abnormal cells and degree of air trapping and lung abnormalities will be described through simple correlation. Exploration of non-linear relationships or rank-based summaries will be considered as appropriate.

    Up to 1 year

Secondary Outcomes (1)

  • Comparison of epithelial cell populations in allogeneic hematopoietic cell transplant recipients and lung graft recipients

    Up to 1 year

Study Arms (1)

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.

Procedure: Biospecimen CollectionOther: Medical Chart Review

Interventions

Biospecimen CollectionPROCEDURE

Undergo collection of blood, airway brushings.

Ancillary-correlative (biospecimen collection, chart review)
Medical Chart ReviewOTHER

Patients' medical records are reviewed

Also known as: Chart Review
Ancillary-correlative (biospecimen collection, chart review)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with BOS who have undergone an allo-HCT or lung allograft.

You may qualify if:

  • 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)
  • 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)
  • 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
  • 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
  • patients with BOS Stage 2 or higher (\>= 35% decline in FEV1 from baseline values)
  • patient with BOS Stage 0p or 1 (10-35% decline in FEV1 from baseline values)
  • 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)

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood, airway brushings

MeSH Terms

Conditions

Bronchiolitis Obliterans

Condition Hierarchy (Ancestors)

BronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Ajay Sheshadri

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ajay Sheshadri

CONTACT

713-792-6238asheshadri@mdanderson.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2020

First Posted

October 27, 2020

Study Start

August 27, 2020

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations

US(1)