Patient-derived Organoid Model and Circulating Tumor Cell... | NCT03655015

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

NCT03655015

Sponsor

The University of Texas Health Science Center at San Antonio

Status

Recruiting

Last Update Posted

Apr 20, 2026Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Lung Neoplasm

Interventions

Lung Tumor Resection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
HSC20180485H	Other Identifier	UT Health Science Center Institutional Review Board
R01CA269766	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 16, 2018Actual

Primary Completion Date

Dec 1, 2028Estimated

Completion Date

Dec 1, 2029Estimated

First Submitted Date

Aug 29, 2018

First Submission Date that Met QC Criteria

Aug 29, 2018

First Posted Date

Aug 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2026

Last Update Posted Date

Apr 20, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Josephine Taverna, Principal Investigator, The University of Texas Health Science Center at San AntonioPrincipal Investigator

Lead Sponsor

The University of Texas Health Science Center at San AntonioOTHER

Collaborators

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Estimated

Name	Type	Description	Arm Group Labels	Other Names
Lung Tumor Resection	Procedure	Lung Tumor Resection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Lung cancer patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Josephine Taverna, MD	Contact	210-450-8234		tavernaj@uthscsa.edu

Overall Officials

Name	Affiliation	Role
Josephine Taverna, MD	UT Health San Antonio M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UT Health San Antonio, M.D. Anderson Cancer Center	Recruiting	San Antonio	Texas	78229	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

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Browse Branches

Not provided