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

Prior treatment

• Significant chest wall or spinal deformity expected to cause severe restriction after transplantation

Other illness

• 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
• 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

Other

• Body mass index more than 35 kg/m2

• 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
• 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
  • 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