DREAM: Double Lung Transplant Registry for Lung Cancers
This study, called DREAM, is looking at the results for patients who receive a double lung transplant to treat certain cancers that are only in the lungs and haven't spread. This is an observational study, meaning researchers will collect information about your health and the transplant outcomes. You might be able to join if you are between 18 and 75 years old and are having a double lung transplant for a lung-limited cancer that hasn't responded to other treatments. The researchers want to see how long patients live after the transplant (overall survival) and how long they live without the cancer returning (disease-free survival) at 30 and 90 days.
- Study design
- This is an observational study that plans to include 125 participants. It is not a randomized study, meaning participants are not assigned to different treatment groups.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track your overall survival and disease-free survival at 30 and 90 days after the transplant.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05671887
DREAM: Double Lung Transplant REgistry Aimed for Lung-limited Malignancies
Recruiting
Not specifiedAges 18–75ObservationalNorthwestern UniversityInvestigator-initiated
~125 participants
Updated 2024-11-14 on ClinicalTrials.gov
What's tested:Double Lung Transplantation
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
overall survival (OS) rate
Measured over 30-day
+7 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesIllinois1
Study leadership
- Young Chae, MD MPH MBA · PRINCIPAL_INVESTIGATOR · Northwestern University
- Ankit Bharat, MD · PRINCIPAL_INVESTIGATOR · Northwestern University
- Rade Tomic, MD · PRINCIPAL_INVESTIGATOR · Northwestern University
Who to contact
Lung Transplant Thoracic Surgery, Canning Thoracic Institute (Northwestern Memorial Hospital)
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Adults of Age ≦ 80
Resistant or refractory to or without available standard of care treatment options or experimental treatment options that are known to increase survival outcome
Patients without any extrapulmonary disease
Patients with good general health with an ability to withstand physiologic stressors and undergo psychosocial evaluation by the Stanford Integrated Psychosocial Assessment for Transplantation (SIPAT) or other assessment tools
Patients to meet all other criteria for lung transplantation including insurance approval and United Network for Organ Sharing (UNOS) registration
Histologically confirmed selected lung non-small cell lung cancer including but not limited to:
Adenocarcinoma in situ
Minimally invasive adenocarcinoma
Non mucinous lepidic predominant invasive adenocarcinoma
Mixed invasive mucinous and mucinous adenocarcinoma
Colloid adenocarcinoma
Enteric adenocarcinoma
Minimally invasive adenocarcinoma
Nonmucinous
Mucinous
Atypical adenomatous hyperplasia
Adenocarcinoma in situ
Nonmucinous
Mucinous
based on the 2004 WHO classification of lung tumors including - Bronchioloalveolar carcinoma
Nonmucinous
Mucinous
Mixed nonmucinous and mucinous or indeterminate
Without any distant metastasis confirmed by standard staging work-up
Without brain metastasis confirmed by brain imaging
Without unidentified primary site of cancer
Metastatic cancers to lung alone - including but not limited to germ cell tumors, head \& neck tumors, colorectal tumors, renal cell tumors, testicular cancer
Without any other distant metastasis confirmed by standard staging work-up
Respiratory failure with a history of cancer in the last 5 years - including, but not limited to interstitial lung disease (ILD), pulmonary fibrosis (idiopathic or secondary), advanced chronic obstructive pulmonary disease (COPD), bronchiectasis, emphysema, cystic fibrosis (CF), emphysema due to alpha-1 antitrypsin deficiency, and pulmonary arterial hypertension (PAH)
Without any other distant metastasis confirmed by standard staging work-up
Exclusion
Adults unable or unwilling to consent
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Prisoners
Vulnerable Populations
Presence of extrapulmonary disease or mediastinal nodal disease at the time of transplant referral
Small Cell Cancers
Unidentified primary site of cancer for Cohort A
Progression of disease or confirmed distant metastases or mediastinal nodal disease at any point during transplantation work-up
Medical ineligibility for lung transplantation after multidisciplinary assessment
Not a suitable candidate according to the lung transplantation protocol for treatment of lung confined primary or metastatic tumors
Body mass index more than 35 kg/m2
Evidence of co-existing malignancies for Cohort A
Untreatable significant dysfunction of another major organ system including heart, liver, kidney, or brain unless combined organ transplantation can be performed
Uncorrected atherosclerotic disease with suspected or confirmed end-organ ischemia or dysfunction and/or coronary artery disease not amenable to revascularization
Uncorrectable bleeding diathesis
Evidence of active Mycobacterium tuberculosis infection
Significant chest wall or spinal deformity expected to cause severe restriction after transplantation
What this trial measures
- overall survival (OS) rate30-day
- overall survival (OS) rate90-day
- disease-free survival (DFS) rate30-day
- disease-free survival (DFS) rate90-day
- allograft rejection (AR) rate30-day
- allograft rejection (AR) rate90-day
- allograft survival (AS) rate30-day
- allograft survival (AS) rate90-day