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

NCT ID: NCT03655015

Last Updated: 2025-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-16

Study Completion Date

2029-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Lung Neoplasm

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Lung Tumor Resection

Lung Tumor Resection

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Josephine Taverna, MD

Role: PRINCIPAL_INVESTIGATOR

UT Health San Antonio M.D. Anderson Cancer Center

Locations

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

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Josephine Taverna, MD

Role: CONTACT

210-450-8234

Facility Contacts

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Epp Goodwin

Role: primary

Other Identifiers

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HSC20180485H

Identifier Type: OTHER

Identifier Source: secondary_id

R01CA269766

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CTMS# 18-0056

Identifier Type: -

Identifier Source: org_study_id

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