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

Sponsor
The University of Texas Health Science Center at San Antonio (Other)
Overall Status
Recruiting
CT.gov ID
NCT03655015
Collaborator
(none)
150
1
73.5
2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Patient-derived Organoid Model and Circulating Tumor Cells for Treatment Response of Lung Cancer (CTMS 18-0056)
Actual Study Start Date :
Oct 16, 2018
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Correlation of PDO and Circulating tumor cells (CTCs) [10 years]

    To establish a connection between PDOs and CTCs, and their relationship to cancer

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 UT Health San Antonio, M.D. Anderson Cancer Center San Antonio Texas United States 78229

Sponsors and Collaborators

  • The University of Texas Health Science Center at San Antonio

Investigators

  • Principal Investigator: Josephine Taverna, MD, UT Health San Antonio M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT03655015
Other Study ID Numbers:
  • CTMS# 18-0056
  • HSC20180485H
First Posted:
Aug 31, 2018
Last Update Posted:
Nov 24, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 24, 2021