NCT05671887 · Northwestern University
DREAM: Double Lung Transplant REgistry Aimed for Lung-limited Malignancies
(DREAM)
What this study is about
This is a forward-looking 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.
View original scientific description
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.
Interventions
PROCEDURE
Double Lung Transplantation
To evaluate outcomes among patients who undergo lung transplantation for treatment of a select group of medically refractory cancers affecting the lungs alone without extrapulmonary nodal and distant metastasis.
Primary outcome measures
overall survival (OS) rate
Time frame: 30-day
overall survival (OS) rate
Time frame: 90-day
disease-free survival (DFS) rate
Time frame: 30-day
disease-free survival (DFS) rate
Time frame: 90-day
allograft rejection (AR) rate
Time frame: 30-day
allograft rejection (AR) rate
Time frame: 90-day
allograft survival (AS) rate
Time frame: 30-day
allograft survival (AS) rate
Time frame: 90-day
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- based on the 2004 WHO classification of lung tumors including - Bronchioloalveolar carcinoma
- Nonmucinous
- 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
- Adults unable or unwilling to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- 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
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 14, 2024 · Source of record for eligibility and locations