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

Recruiting

• Conditions: Lung Neoplasm

• Registration Number: NCT03655015
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-08-29
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-08-31
• Study Start: 2018-10-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07
• Primary Completion: 2028-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	10 years	Establishment of a living biobank of PDOs and the potential of PDOs to repeat their process outside a living organism

Secondary Outcome Measures

Name	Time	Method
Correlation of PDO and Circulating tumor cells (CTCs)	10 years	To establish a connection between PDOs and CTCs, and their relationship to cancer

Trial Locations

Locations (1)

UT Health San Antonio, M.D. Anderson Cancer Center; 🇺🇸 San Antonio, Texas, United States