Registry for double lung transplants in patients with lung-limited cancers
Double Lung Transplant REgistry Aimed for Lung-limited Malignancies (DREAM) - a Prospective Observational Registry Study for Patients Undergoing Lung Transplantation for Medically Refractory Cancers Confined to the Lungs
This study is collecting information on patients with lung-limited cancers who are getting double lung transplants to see how well the procedure works for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05671887 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to collect data on patients undergoing double lung transplantation specifically for lung-limited malignancies that do not have extrapulmonary disease. The study will track outcomes and survival rates in this unique patient population, which has historically been underrepresented in lung transplant procedures. By focusing on patients with refractory lung cancer and those with lung-limited metastasis, the registry seeks to provide insights into the efficacy and safety of lung transplantation as a treatment option. Participants will be evaluated based on strict eligibility criteria to ensure they are suitable candidates for the procedure.
Who should consider this trial
Good fit: Ideal candidates include adults up to 80 years old with refractory lung cancer or lung-limited metastasis and no extrapulmonary disease.
Not a fit: Patients with extrapulmonary disease or those who do not meet the eligibility criteria for lung transplantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could improve treatment options and outcomes for patients with lung-limited cancers requiring transplantation.
How similar studies have performed: While lung transplantation for cancer is uncommon, there have been successful reports in similar cases, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 * 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 Inclusion Criteria for Cohort B * 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 Inclusion Criteria for Cohort C * 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 Criteria: * 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 this trial is running
Chicago, Illinois
- Thoracic Surgery, Canning Thoracic Institute (Northwestern Memorial Hospital) — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Young Chae, MD MPH MBA — Northwestern University
- Study coordinator: Lung Transplant Thoracic Surgery, Canning Thoracic Institute (Northwestern Memorial Hospital)
- Email: anne.oboye@nm.org
- Phone: 312-695-5864
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.