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Prospective Primary Human Lungcancer Organoids to Predict Treatment Response (Organoids lung)

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ClinicalTrials.gov Identifier: NCT04859166
Recruitment Status : Recruiting
First Posted : April 26, 2021
Last Update Posted : February 23, 2022
Sponsor:
Information provided by (Responsible Party):
Maastricht Radiation Oncology

Brief Summary:
Organoids are generated from tumor biopsies, taken during a standard procedure. and are a collection of organ-specific cell types that are able to self-organize in-vitro in a manner similar to the in-vivo situation (3D). They have the capability to facilitate in-depth analysis of patient's own tumor material at point of diagnosis and during progressive/recurrent disease. There is currently no published protocol to establish long-term lung cancer organoids from lung cancer patients. Such a methodology would enable the prospective identification of 'patient tailored optimal treatments" as well as the derivation of predictive biomarkers for response and relapse. Apart from organoids, xenograft models also still have their merits. To generate PDX, tumor material will be retrieved from surgical specimens, cut in small pieces, transplanted in the recipient immune deficient animals either subcutaneously or implanted directly into the lung. A tumor with the median growth rate will be serially transplanted in vivo for further therapeutic experiments. Dedicated small animal irradiaton in our facility enables precise local irradiation of lung tumors with minimal radiation exposure of the surrounding normal tissues. Integrated cone beam computed tomography imaging system allows longitudinal monitoring of tumor response to novel treatments.

Condition or disease Intervention/treatment
Lung Cancer Procedure: Organoids

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prospective Primary Human Lungcancer Organoids to Predict Treatment Response
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : November 15, 2022
Estimated Study Completion Date : November 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer


Intervention Details:
  • Procedure: Organoids
    A part of the tumor of approximately 1 cm3 will be removed from the primary tumor.


Primary Outcome Measures :
  1. Bio-banking [ Time Frame: 5 years ]
    To establish long term culturing and bio-banking conditions for primary lung cancer organoids.

  2. Frequency of organoid formation [ Time Frame: 5 years ]
    To determine the frequency of primary, secondary and tertiary organoid formation

  3. Distribution [ Time Frame: 5 years ]
    The size distribution of the organoids

  4. Proliferation [ Time Frame: 5 years ]
    The rate of proliferation and cell death (turnover) will be calculated

  5. PDX models of lung cancer [ Time Frame: 5 years ]
    To establish PDX models of lung cancer by means of passaging and expansion through subcutaneous engraftment in immune deficient animals and create PDX tumor bank for subsequent experiments

  6. Established PDX histologically [ Time Frame: 5 years ]
    To characterize established PDX histologically and to compare these characteristics with donor tissue

  7. Established PDX genetically [ Time Frame: 5 years ]
    To characterize established PDX genetically (most frequently occurring driver mutations in lung cancer) and to compare these characteristics with donor tissue

  8. Established PDX biologically [ Time Frame: 5 years ]
    To characterize established PDX biologically (proliferation, tumor microenvironment, etc.) and to compare these characteristics with donor tissue

  9. Test treatments [ Time Frame: 5 years ]
    Using PDX models to test novel anti-cancer treatments such as a hypoxia-activated prodrug (HAP) in combination with radiation

  10. Test treatments [ Time Frame: 5 years ]
    Using PDX models to develop predictive assay of tumor response to HA


Secondary Outcome Measures :
  1. Test hypotheses [ Time Frame: 5 years ]
    The organoids will be used to test hypotheses such as epi-genetic stability, response to targeted and cytotoxic therapies

  2. Generate cell lines [ Time Frame: 5 years ]
    Use the PDX to generate cancer cell lines for in vitro assays to test intrinsic sensitivity of cells to HAPs and other drugs in 2D and 3D settings


Biospecimen Retention:   Samples With DNA
A part of the tumor of approximately 1 cm3 will be removed from the primary tumor.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
In a one year period,30 patients who are selected to undergo surgical removal of a primary lung cancer will be included. The tumor material that will be used to make organoids will be derived from 'left-over' tumor tissue that is not needed for the pathologist to make a diagnosis, to stage the patient or to perform a molecular diagnosis. The patient therefore does not require to undergo additional treatments or procedures.
Criteria

Inclusion Criteria:

- Undergo primary surgical resection of a primary lung cancer (e.g. wedge resection, segmental resection, lobectomy, pneumonectomy)

Exclusion Criteria:

- Preceding induction treatment (e.g. induction chemotherapy or chemo-radiotherapy)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04859166


Contacts
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Contact: Chantal Overhof, Bsc +31 88 44 55 686 chantal.overhof@maastro.nl
Contact: Ann Caessens +31 44 55 686 ann.claessens@maastro.nl

Locations
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Netherlands
Zuyderland Medical Center Recruiting
Heerlen, Netherlands, 6419 PC
Contact: Chantal Overhof, Bsc    +31 44 55 686    chantal.overhof@maastro.nl   
Contact: Ann Claessens    +31 44 55 686    ann.claessens@maastro.nl   
Principal Investigator: Gerben Bootsma, MD         
Maastro Recruiting
Maastricht, Netherlands, 6229 ET
Contact: Chantal Overhof-Wedick, Bsc    +31 44 55 686    chantal.overhof@maastro.nl   
Contact: Ann Claessens    +31 44 55 686    ann.claessens@maastro.nl   
Principal Investigator: Marc Vooijs, PhD         
Sponsors and Collaborators
Maastricht Radiation Oncology
Investigators
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Principal Investigator: Marc Vooijs, MD, PhD Maastro
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Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT04859166    
Other Study ID Numbers: Organoids lung
First Posted: April 26, 2021    Key Record Dates
Last Update Posted: February 23, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht Radiation Oncology:
Organoids
Lung
Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases