Parametric Response Mapping (PRM) for the Detection of Chronic Lung Injury in Hematopoietic Cell Transplant Recipients

Part of paid clinical trials in Stanford, California.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT05866302
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
36 Months - N/A
Healthy Volunteers
Not accepted

Study Details

The study will have two separate patient cohorts: Cohort 1 will include patients with newly diagnosed chronic graft versus host disease (GVHD), whereas cohort 2 will include patients with newly diagnosed chronic lung disease (CLD). For cohort 1, the primary objective will be to characterize PRM metrics at the onset of chronic GVHD and determine if a PRM signature is present that will predict 1-year CLD free survival. For cohort 2, the primary objective will focus on characterizing PRM at the onset of CLD and determine if PRM can predict the trajectory in lung function decline in affected patients.

Key Dates

Start date
May 30, 2023
Status verified
Oct 2025
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
375 participants (estimated)

Arms

  • Arm: Cohort 1: Newly diagnosed chronic GVHD
    All subjects will undergo a non-contrast, high resolution CT scan with inspiratory and expiratory imaging, pulmonary function testing (PFT) and serologic biomarker studies upon entry. A total of 300 subjects (200 adults, 100 pediatric) will be enrolled. Patients in cohort 1 who develop CLD prior to the 12-month period will transition to cohort 2 at that time. PFT is recommended every 3 months over a 12 month period. Plasma samples will be collected at entry and at 12 months.
  • Arm: Cohort 2: Newly diagnosed chronic lung disease (CLD)
    All subjects will undergo a non-contrast, high resolution CT scan with inspiratory and expiratory imaging, pulmonary function testing (PFT) and serologic biomarker studies upon entry. A total of 75 subjects (50 adults, 25 pediatric) will be enrolled. PFT is recommended every 3 months over a 12 month period. Plasma samples will be collected at entry and at 12 months.

Primary Outcome Measure

1-year CLD free survival (Cohort 1) [ Time Frame: up to 12 months from enrollment ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Stanford HospitalStanfordCalifornia94305
Joe Hsu (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30322
Kirsten Williams
[email protected]
Kirsten Williams (PRINCIPAL_INVESTIGATOR)
Dana FarberBostonMassachusetts02215
Christine Duncan
[email protected]
Christine Duncan (PRINCIPAL_INVESTIGATOR)
The University of Michigan Cancer CenterAnn ArborMichigan48109
Cancer AnswerLine
800-865-1125
Cancer AnswerLine
1-800-865-1125
Gregory A Yanik, MD (PRINCIPAL_INVESTIGATOR)
MD AndersonHoustonTexas77030
Ajay Sheshadri
[email protected]
Ajay Sheshadri (PRINCIPAL_INVESTIGATOR)
Fred Hutchinson Cancer Research CenterSeattleWashington98109
Guan-Shing Cheng
[email protected]
Guang-Shing Cheng (PRINCIPAL_INVESTIGATOR)

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By research site
Stanford Hospital· Stanford, CAEmory University· Atlanta, GADana Farber· Boston, MAThe University of Michigan Cancer Center· Ann Arbor, MIMD Anderson· Houston, TXFred Hutchinson Cancer Research Center· Seattle, WA

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