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Recruiting NCT03655015

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

Observational Lung Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lung Tumor Resection.
Who it may be relevant to
Registry conditions: Lung Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Procedure Lung Tumor Resection
    Lung Tumor Resection

Primary outcome measures

  • 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. [Time frame: 10 years]
Secondary outcome measures (1)
  • Correlation of PDO and Circulating tumor cells (CTCs) [Time frame: 10 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 1 center
  • UT Health San Antonio, M.D. Anderson Cancer Center — San Antonio

Identifiers

NCT: NCT03655015 · CTMS# 18-0056 · HSC20180485H · R01CA269766

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗