Actively Recruiting

Age: 18Years - 75Years
All Genders
ID05671887

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

Led by Northwestern University · Updated on 2024-11-14

125

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are observing patients who receive double lung transplants to treat certain medically resistant cancers limited to the lungs without spread to other parts of the body. This study focuses on understanding outcomes after lung transplantation for selected lung cancers and metastases, including those with no other treatment options and good general health. The goal is to assess survival, disease recurrence, and graft function over time in carefully selected patients. Participants undergo double lung transplantation as part of their clinical care. The study includes three groups: patients with primary lung cancers, patients with lung-only metastases from other cancers, and patients with respiratory failure plus recent cancer history. The study monitors patients after transplant to analyze survival and disease progression rates at multiple intervals, from 30 days up to 5 years. Throughout the study, patients will have ongoing assessments including survival status, disease-free status, and graft health at various time points. Researchers will also collect molecular and genetic data to explore links with patient outcomes. The study will continue monitoring participants long-term to better understand factors that affect post-transplant success in this unique patient population.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 80 years
  • Undergoing double lung transplantation as part of clinical care
  • Medically refractory or resistant to standard and experimental cancer treatments
  • Cancer limited to the lungs without extrapulmonary or nodal metastasis
  • Good general health and able to undergo psychosocial evaluation
  • Meet all other lung transplantation criteria including insurance and registration
  • Specific diagnoses include selected non-small cell lung cancers, lung-only metastatic cancers, or respiratory failure with cancer history in last 5 years
Not Eligible

You will not qualify if you...

  • Unable or unwilling to consent
  • Under 18 years old
  • Pregnant women
  • Prisoners or vulnerable populations
  • Extrapulmonary or mediastinal nodal disease at transplant referral
  • Small cell lung cancers
  • Unidentified primary cancer site for primary lung cancer group
  • Disease progression or distant metastasis during transplant work-up
  • Medically ineligible for lung transplantation
  • Body mass index over 35 kg/m2
  • Other active malignancies in primary lung cancer group
  • Untreatable major organ dysfunction unless combined transplant
  • Uncorrected atherosclerotic disease or coronary artery disease not treatable
  • Uncorrectable bleeding disorders
  • Active tuberculosis infection
  • Severe chest wall or spinal deformity expected to cause restriction after transplant

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Double Lung Transplantation

Duration - Single event with immediate post-operative period

Participants undergo double lung transplantation as part of their clinical care for medically refractory cancers limited to the lungs.

1 surgical procedure and immediate hospital care

Post-operative Follow-up

Duration - Up to 5 years

Participants are monitored after transplantation to assess survival, disease recurrence, graft function, and potential complications.

Multiple follow-up visits over 5 years

Trial Site Locations

Total: 1 location

1

Thoracic Surgery, Canning Thoracic Institute (Northwestern Memorial Hospital)

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

L

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

L

Liam Il-Young Chung, MD MPH

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

Early outcomes after lung transplantation for severe COVID-19: a series of the first consecutive cases from four countries.

Ankit Bharat, Tiago N Machuca, Melissa Querrey...

https://pubmed.ncbi.nlm.nih.gov/33811829

Metastatic bronchioloalveolar carcinoma and metastatic adenocarcinoma of the lung: comparison of clinical manifestations, chemotherapeutic responses, and prognosis.

E R Feldman, R T Eagan, D J Schaid

https://pubmed.ncbi.nlm.nih.gov/1310129

Role of lung transplantation in the treatment of bronchogenic carcinomas for patients with end-stage pulmonary disease.

Marc de Perrot, Susan Chernenko, Thomas K Waddell...

https://pubmed.ncbi.nlm.nih.gov/15514376