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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tracks patients who receive a double lung transplant, which replaces both lungs. It includes adults up to age 80 with certain hard-to-treat cancers found only in the lungs, or lung failure and a history of cancer in the past 5 years. It observes their care rather than testing a new treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be an adult age 80 or younger who is having a double lung transplant and agrees to join the study.
  • Have cancer that has resisted treatment, or have no standard or experimental treatment options known to help people live longer.
  • Have no disease outside the lungs and no cancer spread to other distant sites, as checked by standard tests.
  • Be healthy enough to handle the transplant and have an assessment of mental health and social support.
  • Meet all other lung transplant rules, including insurance approval and registration with the United Network for Organ Sharing.
  • Group A: Have a tissue test showing an eligible type of non-small cell lung cancer. The cancer's starting site must be known, and brain scans must show no cancer spread.
  • Group B: Have cancer that spread from another body site to the lungs only. Examples include colon, kidney, testicular, and head and neck cancers.
  • Group C: Have lung failure and a history of cancer in the past 5 years. Lung conditions may include lung scarring, COPD, cystic fibrosis, or high blood pressure in the lungs.

Who can't join

  • Be unable or unwilling to agree to join, be under adult age, be pregnant, be a prisoner, or belong to a group the study considers vulnerable.
  • Have disease outside the lungs or cancer in lymph nodes between the lungs at referral; or have worsening disease or confirmed cancer spread during transplant testing.
  • Have small cell cancer; or, for Group A, have another cancer at the same time or cancer with an unknown starting site.
  • Be found medically unable to have a lung transplant or not meet the study's transplant rules.
  • Have a body mass index (BMI), a measure based on height and weight, over 35.
  • Have serious, untreatable heart, liver, kidney, or brain problems, unless a combined organ transplant is possible.
  • Have uncorrected artery disease that limits blood flow or harms organs, heart artery disease that cannot be treated to restore blood flow, or a bleeding disorder that cannot be corrected.
  • Have active tuberculosis (TB), or a chest wall or spine shape problem expected to severely limit breathing after transplant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

IL