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

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

Create a living biobank of PDOs from Stage I-III lung cancer patients.

Study Overview

• Status: Recruiting
• Conditions: Lung Neoplasm
• Intervention / Treatment: Procedure: Lung Tumor Resection

Detailed Description

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.

1. Establishment and culture of PDOs from lung cancer tumor specimens. PDOs will be biobanked for future experiments.
2. 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).
3. 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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Josephine Taverna, MD; Phone Number: 210-450-8234; Email: tavernaj@uthscsa.edu

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • UT Health San Antonio, M.D. Anderson Cancer Center
      • Principal Investigator: Josephine Taverna, MD
      • Contact: Epp Goodwin; Email: CTRCReferral@uthscsa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Lung cancer patients

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Josephine Taverna, MD, UT Health San Antonio M.D. Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2018
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: August 29, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Lung Neoplasms; Neoplastic Cells, Circulating
• Other Study ID Numbers: CTMS# 18-0056; HSC20180485H (Other Identifier: UT Health Science Center Institutional Review Board); R01CA269766 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No