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

Lung Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03655015
• Other study ID #: CTMS# 18-0056
• Secondary ID: HSC20180485HR01C
• Status: Recruiting
• Start date: October 16, 2018
• Est. completion date: December 2029

Study information

• Verified date: December 2023
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Josephine Taverna, MD
• Phone: 210-450-8234
• Email: tavernaj[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2029
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasm
• Lung Neoplasms
• Neoplastic Cells, Circulating

Intervention

Procedure:
• Lung Tumor Resection
Lung Tumor Resection

Locations

Country	Name	City	State
United States	UT Health San Antonio, M.D. Anderson Cancer Center	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation of PDO and Circulating tumor cells (CTCs)	To establish a connection between PDOs and CTCs, and their relationship to cancer	10 years