DREAM: Double Lung Transplant REgistry Aimed for Lung-limited Malignancies
DREAM
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
2 other identifiers
observational
125
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 16, 2022
CompletedFirst Submitted
Initial submission to the registry
December 19, 2022
CompletedFirst Posted
Study publicly available on registry
January 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2032
November 14, 2024
November 1, 2024
10 years
December 19, 2022
November 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
overall survival (OS) rate
30-day
overall survival (OS) rate
90-day
disease-free survival (DFS) rate
30-day
disease-free survival (DFS) rate
90-day
allograft rejection (AR) rate
30-day
allograft rejection (AR) rate
90-day
allograft survival (AS) rate
30-day
allograft survival (AS) rate
90-day
Secondary Outcomes (5)
overall survival (OS) rate
6-month, 1-year, 3-year, and 5-year
disease-free survival (DFS) rate
6-month, 1-year, 3-year, and 5-year
allograft rejection (AR) rate
6-month, 1-year, 3-year, and 5-year
allograft survival (AS) rate
6-month, 1-year, 3-year, and 5-year
Major post-transplantation morbidity (MPTM)
6-month, 1-year, 3-year, and 5-year
Study Arms (3)
Cohort A: Primary lung cancers
\- Examples include invasive mucinous/non-mucinous non-small cell lung cancers and multifocal carcinomas
Cohort B: Metastatic cancers to the lung only
\- Examples include germ cell tumors, head \& neck tumors, colorectal tumors, renal cell tumors
Cohort C: Respiratory failure with a history of cancer in the last 5 years
\- Examples include, 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)
Interventions
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.
Eligibility Criteria
This is a prospective observational registration trial for patients who undergo lung transplantation using cadaveric organs for medically refractory cancers affecting the lungs alone and without extrapulmonary metastasis after meeting the inclusion criteria of the clinical program at Northwestern Medicine and participating centers. Essential Clinical Criteria: 1. The tumor should be without any extrapulmonary metastasis as determined by standard of care diagnostic and staging workup. 2. All standard of care or experimental oncological treatments known to improve survival should have failed or deemed infeasible 3. Patients should meet the general criteria for lung transplant evaluation and listing
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.
- 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
- +21 more criteria
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thoracic Surgery, Canning Thoracic Institute (Northwestern Memorial Hospital)
Chicago, Illinois, 60611, United States
Related Publications (13)
Bharat A, Machuca TN, Querrey M, Kurihara C, Garza-Castillon R Jr, Kim S, Manerikar A, Pelaez A, Pipkin M, Shahmohammadi A, Rackauskas M, Kg SR, Balakrishnan KR, Jindal A, Schaheen L, Hashimi S, Buddhdev B, Arjuna A, Rosso L, Palleschi A, Lang C, Jaksch P, Budinger GRS, Nosotti M, Hoetzenecker K. Early outcomes after lung transplantation for severe COVID-19: a series of the first consecutive cases from four countries. Lancet Respir Med. 2021 May;9(5):487-497. doi: 10.1016/S2213-2600(21)00077-1. Epub 2021 Mar 31.
PMID: 33811829BACKGROUNDVan Raemdonck D, Vos R, Yserbyt J, Decaluwe H, De Leyn P, Verleden GM. Lung cancer: a rare indication for, but frequent complication after lung transplantation. J Thorac Dis. 2016 Nov;8(Suppl 11):S915-S924. doi: 10.21037/jtd.2016.11.05.
PMID: 27942415BACKGROUNDGlanville AR, Wilson BE. Lung transplantation for non-small cell lung cancer and multifocal bronchioalveolar cell carcinoma. Lancet Oncol. 2018 Jul;19(7):e351-e358. doi: 10.1016/S1470-2045(18)30297-3. Epub 2018 Jun 29.
PMID: 30084382BACKGROUNDFeldman ER, Eagan RT, Schaid DJ. Metastatic bronchioloalveolar carcinoma and metastatic adenocarcinoma of the lung: comparison of clinical manifestations, chemotherapeutic responses, and prognosis. Mayo Clin Proc. 1992 Jan;67(1):27-32. doi: 10.1016/s0025-6196(12)60273-0.
PMID: 1310129BACKGROUNDGrover FL, Piantadosi S. Recurrence and survival following resection of bronchioloalveolar carcinoma of the lung--The Lung Cancer Study Group experience. Ann Surg. 1989 Jun;209(6):779-90. doi: 10.1097/00000658-198906000-00016.
PMID: 2543339BACKGROUNDAhmad U, Wang Z, Bryant AS, Kim AW, Kukreja J, Mason DP, Bermudez CA, Detterbeck FC, Boffa DJ. Outcomes for lung transplantation for lung cancer in the United Network for Organ Sharing Registry. Ann Thorac Surg. 2012 Sep;94(3):935-40; discussion 940-1. doi: 10.1016/j.athoracsur.2012.04.069. Epub 2012 Jul 25.
PMID: 22835555BACKGROUNDGarver RI Jr, Zorn GL, Wu X, McGiffin DC, Young KR Jr, Pinkard NB. Recurrence of bronchioloalveolar carcinoma in transplanted lungs. N Engl J Med. 1999 Apr 8;340(14):1071-4. doi: 10.1056/NEJM199904083401403.
PMID: 10194236BACKGROUNDPaloyan EB, Swinnen LJ, Montoya A, Lonchyna V, Sullivan HJ, Garrity E. Lung transplantation for advanced bronchioloalveolar carcinoma confined to the lungs. Transplantation. 2000 Jun 15;69(11):2446-8. doi: 10.1097/00007890-200006150-00041.
PMID: 10868657BACKGROUNDZorn GL Jr, McGiffin DC, Young KR Jr, Alexander CB, Weill D, Kirklin JK. Pulmonary transplantation for advanced bronchioloalveolar carcinoma. J Thorac Cardiovasc Surg. 2003 Jan;125(1):45-8. doi: 10.1067/mtc.2003.72.
PMID: 12538984BACKGROUNDde Perrot M, Chernenko S, Waddell TK, Shargall Y, Pierre AF, Hutcheon M, Keshavjee S. Role of lung transplantation in the treatment of bronchogenic carcinomas for patients with end-stage pulmonary disease. J Clin Oncol. 2004 Nov 1;22(21):4351-6. doi: 10.1200/JCO.2004.12.188.
PMID: 15514376BACKGROUNDWeill D, Benden C, Corris PA, Dark JH, Davis RD, Keshavjee S, Lederer DJ, Mulligan MJ, Patterson GA, Singer LG, Snell GI, Verleden GM, Zamora MR, Glanville AR. A consensus document for the selection of lung transplant candidates: 2014--an update from the Pulmonary Transplantation Council of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2015 Jan;34(1):1-15. doi: 10.1016/j.healun.2014.06.014. Epub 2014 Jun 26.
PMID: 25085497BACKGROUNDDueland S, Grut H, Syversveen T, Hagness M, Line PD. Selection criteria related to long-term survival following liver transplantation for colorectal liver metastasis. Am J Transplant. 2020 Feb;20(2):530-537. doi: 10.1111/ajt.15682. Epub 2019 Nov 28.
PMID: 31674105BACKGROUNDHernandez-Alejandro R, Ruffolo LI, Sasaki K, Tomiyama K, Orloff MS, Pineda-Solis K, Nair A, Errigo J, Dokus MK, Cattral M, McGilvray ID, Ghanekar A, Gallinger S, Selzner N, Claasen MPAW, Burkes R, Hashimoto K, Fujiki M, Quintini C, Estfan BN, Kwon CHD, Menon KVN, Aucejo F, Sapisochin G. Recipient and Donor Outcomes After Living-Donor Liver Transplant for Unresectable Colorectal Liver Metastases. JAMA Surg. 2022 Jun 1;157(6):524-530. doi: 10.1001/jamasurg.2022.0300.
PMID: 35353121BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young Chae, MD MPH MBA
Northwestern University
- PRINCIPAL INVESTIGATOR
Ankit Bharat, MD
Northwestern University
- PRINCIPAL INVESTIGATOR
Rade Tomic, MD
Northwestern University
Central Study Contacts
Lung Transplant Thoracic Surgery, Canning Thoracic Institute (Northwestern Memorial Hospital)
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 19, 2022
First Posted
January 5, 2023
Study Start
November 16, 2022
Primary Completion (Estimated)
November 1, 2032
Study Completion (Estimated)
November 1, 2032
Last Updated
November 14, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share