DREAM: Double Lung Transplant REgistry Aimed for Lung-limited Malignancies

Recruiting now

Conditions studied: Lung Cancer, Bilateral Cancer, Lung Transplant

In brief

This is a prospective observational registration trial for patients who undergo lung transplantation for the treatment of the select groups of medically refractory cancers affecting the lungs alone without extrapulmonary nodal and distant metastasis.

Key facts

Study ID

NCT05671887

Run by

Northwestern University

People needed

125

Starts

2022-11-16

Expected to finish

2032-11-01

Last updated by the study team

2024-11-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Any patient who is undergoing double lung transplantation as part of the clinical program, consents for this prospective observational trial, and has one of the following conditions will be eligible.
• Common Inclusion Criteria
• 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
• Inclusion Criteria for Cohort A
• Histologically confirmed selected lung non-small cell lung cancer including but not limited to:
• o according to the International Association for the Study of Lung Cancer (IASLC)/American Thoracic Society (ATS)/European Respiratory Society (ERS) classification
• Lepidic dominant pattern
• Adenocarcinoma in situ
• Minimally invasive adenocarcinoma
• Non mucinous lepidic predominant invasive adenocarcinoma
• o based on 2015 World Health Organization (WHO) classification of lung tumors including
• Invasive mucinous adenocarcinoma
• Mixed invasive mucinous and mucinous adenocarcinoma
• Colloid adenocarcinoma
• Enteric adenocarcinoma
• Minimally invasive adenocarcinoma
• Nonmucinous
• Mucinous
• Preinvasive lesions
• Atypical adenomatous hyperplasia
• Adenocarcinoma in situ

You may not qualify if…

• Exclusion criteria
• 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

Where it is running

• Thoracic Surgery, Canning Thoracic Institute (Northwestern Memorial Hospital) — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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