Patient-derived Organoid Model and Circulating Tumor Cells for Treatment Response of Lung Cancer

Study Overview
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Brief Summary
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Create a living biobank of PDOs from Stage I-III lung cancer patients.

Detailed Description
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Creation a living biobank of PDOs from Stage I-IV lung cancer patients (n=50). We selected enrollment of at least 50 patients so that they can be risk stratified based on lung tumor type, staging and we plan to store these PDOs in biobank for future experiments. For each patient, tumor specimens will be collected at time of their surgery. No specific therapeutic intervention or treatment is provided as part of this study. Establishment and culture of PDOs from lung cancer tumor specimens. PDOs will be biobanked for future experiments. Lung organoids and CTCs will also be cultured and used to study baseline tumor characteristics using histology, immunohistochemistry, atomic force measurements; as well as, oncogenic signaling pathways and proteomic profile of lung organoids and CTCs derived from lung cancer patients (n>50). Patient demographic information and data to be collected using a patient survey data sheet with treatment and survival history collected at pre-defined time period per the protocol schedule.

Official Title
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Patient-derived Organoid Model and Circulating Tumor Cells for Treatment Response of Lung Cancer (CTMS 18-0056)

Conditions
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Lung Neoplasm

Intervention / Treatment
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* Procedure: Lung Tumor Resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Read, consented to and signed the IRB-approved informed consent form prior to any study related procedure. Diagnosis of lung cancer or lung mass or lymphadenopathy that will either systemic treatment or tumor resection as part of standard of care Any clinical stage of lung cancer Adult patients ≥18 years of age Able and willing to complete a questionnaire on their environmental/occupational exposures and smoking/alcohol history Exclusion Criteria: At the discretion of the treating physician, patient will not be able to fulfill the requirements of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Lung Tumor Resection|Lung Tumor Resection|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish and characterize a biobank of patient-derived organoids (PDOs), and investigate the potential of PDOs to recapitulate ex vivo responses to chemotherapeutic and targeted agents observed in the clinic. | Establishment of a living biobank of PDOs and the potential of PDOs to repeat their process outside a living organism | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of PDO and Circulating tumor cells (CTCs) | To establish a connection between PDOs and CTCs, and their relationship to cancer | 10 years |