RECRUITING

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

Conditions

Lung Cancer Bilateral Cancer Lung Transplant Cancer Double Lung Transplant Bronchioloalveolar Carcinoma (BAC)Lepidic Mucinous

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-11-16

Study Completion:2032-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05671887

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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: * Adenocarcinoma in situ * Minimally invasive adenocarcinoma * Non mucinous lepidic predominant invasive adenocarcinoma * Mixed invasive mucinous and mucinous adenocarcinoma * Colloid adenocarcinoma * Enteric adenocarcinoma * Minimally invasive adenocarcinoma * Nonmucinous * Mucinous * 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	* 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

Inclusion Criteria

Exclusion Criteria

* 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:
* Adenocarcinoma in situ
* Minimally invasive adenocarcinoma
* Non mucinous lepidic predominant invasive adenocarcinoma
* Mixed invasive mucinous and mucinous adenocarcinoma
* Colloid adenocarcinoma
* Enteric adenocarcinoma
* Minimally invasive adenocarcinoma
* Nonmucinous
* Mucinous
* 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

* 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

Contacts and Locations

Study Contact

Lung Transplant Thoracic Surgery, Canning Thoracic Institute (Northwestern Memorial Hospital)

CONTACT

312-695-5864

anne.oboye@nm.org

Liam Il-Young Chung, MD MPH

CONTACT

312-472-6245

ilyoung.chung@northwestern.edu

Principal Investigator

Young Chae, MD MPH MBA

PRINCIPAL_INVESTIGATOR

Northwestern University

Ankit Bharat, MD

PRINCIPAL_INVESTIGATOR

Northwestern University

Rade Tomic, MD

PRINCIPAL_INVESTIGATOR

Northwestern University

Study Locations (Sites)

Thoracic Surgery, Canning Thoracic Institute (Northwestern Memorial Hospital)

Chicago, Illinois, 60611

United States

Collaborators and Investigators

Sponsor: Northwestern University

Young Chae, MD MPH MBA, PRINCIPAL_INVESTIGATOR, Northwestern University
Ankit Bharat, MD, PRINCIPAL_INVESTIGATOR, Northwestern University
Rade Tomic, MD, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-16

Study Completion Date2032-11

Study Record Updates

Study Start Date2022-11-16

Study Completion Date2032-11

Terms related to this study

Keywords Provided by Researchers

Cancer
Lung Cancer
Bilateral Cancer
Lung Transplant
Double Lung Transplant
Bronchioloalveolar Carcinoma (BAC)
Lepidic
Mucinous

Additional Relevant MeSH Terms

Lung Cancer
Bilateral Cancer
Lung Transplant