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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

∙ 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

Locations
United States
Illinois
Thoracic Surgery, Canning Thoracic Institute (Northwestern Memorial Hospital)
RECRUITING
Chicago
Contact Information
Primary
Lung Transplant Thoracic Surgery, Canning Thoracic Institute (Northwestern Memorial Hospital)
anne.oboye@nm.org
312-695-5864
Backup
Liam Il-Young Chung, MD MPH
ilyoung.chung@northwestern.edu
312-472-6245
Time Frame
Start Date: 2022-11-16
Estimated Completion Date: 2032-11
Participants
Target number of participants: 125
Treatments
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)
Related Therapeutic Areas
Sponsors
Leads: Northwestern University

This content was sourced from clinicaltrials.gov

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