Lung NeoplasmNCT03655015
Patient-derived Organoid Model and Circulating Tumor Cells for Treatment Response of Lung Cancer
An observational study of Lung Neoplasm, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Create a living biobank of PDOs from Stage I-III lung cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasm
- What is being tested?
- Lung Tumor Resection
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2018to 1 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung cancer patients
Who may be able to join
- 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
Who cannot join
- At the discretion of the treating physician, patient will not be able to fulfill the requirements of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Health San Antonio, M.D. Anderson Cancer Center
San Antonio, Texas, 78229
Research Office, 210-450-1000, mccresearch@uthscsa.edu
Josephine Taverna, MD
About this study
Official title: Patient-derived Organoid Model and Circulating Tumor Cells for Treatment Response of Lung Cancer (CTMS 18-0056)
Create a living biobank of PDOs from Stage I-III lung cancer patients.
Read the 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.
- Conditions
- Lung Neoplasm
- Being tested
- Lung Tumor Resection
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Tumor ResectionProcedure or surgery
Lung Tumor Resection
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 years
Secondary outcomes (1)
Correlation of PDO and Circulating tumor cells (CTCs)
To establish a connection between PDOs and CTCs, and their relationship to cancer
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start16 Oct 2018
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Josephine Taverna, The University of Texas Health Science Center at San Antonio
- Investigators
- Josephine Taverna, MD, Principal investigator, UT Health San Antonio M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655015
- Sponsor's protocol ID
- CTMS# 18-0056
- Other IDs
- HSC20180485H, R01CA269766
- Status last verified
- Apr 2026
- First submitted
- 29 Aug 2018
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-derived Organoid Model and Circulating Tumor Cells for Treatment Response of Lung Cancer (CTMS 18-0056)
- ClinicalTrials.gov ID
- NCT03655015
- Acronym / sponsor ID
- CTMS# 18-0056
- Conditions
- Lung Neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung cancer patients
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- At the discretion of the treating physician, patient will not be able to fulfill the requirements of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung Tumor ResectionLung Tumor Resection | Procedure or surgery | – |
Primary outcome
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
1 secondary outcome
Correlation of PDO and Circulating tumor cells (CTCs)
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Josephine Taverna, MD principal investigator
UT Health San Antonio M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasm, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josephine Taverna, MD (210-450-8234, tavernaj@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.