NCT03655015

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
43mo left

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Oct 2018Dec 2029

First Submitted

Initial submission to the registry

August 29, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 16, 2018

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

10.1 years

First QC Date

August 29, 2018

Last Update Submit

April 16, 2026

Conditions

Lung Neoplasm

Outcome Measures

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.

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

    10 years

Secondary Outcomes (1)

  • Correlation of PDO and Circulating tumor cells (CTCs)

    10 years

Interventions

Lung Tumor ResectionPROCEDURE

Lung Tumor Resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lung cancer patients

You may qualify if:

  • 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

You may not qualify if:

  • At the discretion of the treating physician, patient will not be able to fulfill the requirements of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

San Antonio, Texas, 78229, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Patient derived tumor specimens that are cultured into patient-derived organoids (PDOs)

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Josephine Taverna, MD

    UT Health San Antonio M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Josephine Taverna, MD

CONTACT

210-450-8234tavernaj@uthscsa.edu

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 29, 2018

First Posted

August 31, 2018

Study Start

October 16, 2018

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2029

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)