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NCT Number: NCT03655015

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UT Health San Antonio, M.D. Anderson Cancer Center

San Antonio, Texas, 78229, United States

Location status: Recruiting

Location contact

Josephine Taverna, MD

PRINCIPAL_INVESTIGATOR

Research Office

CONTACT

[email protected]

210-450-1000

About this study

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.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lung Tumor Resection

Procedure

Lung Tumor Resection

Primary outcomes

  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.

    Time frame: 10 years

    Establishment of a living biobank of PDOs and the potential of PDOs to repeat their process outside a living organism

Secondary outcomes

  1. Correlation of PDO and Circulating tumor cells (CTCs)

    Time frame: 10 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Josephine Taverna, MD

CONTACT

[email protected]

210-450-8234

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2028
Study completion
2029
First posted
Aug 31, 2018
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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