NCT03890614

Novel 3D Hematological Malignancy Organoid to Study Disease Biology and Chemosensitivity

Novel 3D Hematological Malignancy Organoid Platform to Study Disease Biology and Perform Chemosensitivity Assays for Patient-Specific Care

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this project is to compare chemosensitivity between chemotherapy combinations in bone marrow aspirates using 3D organoid models. The investigators overarching hypothesis is that 3D organoids are ideal to test chemosensitivity in real time, to provide personalized medicine and guidance in the setting of relapsed hematologic malignancy and potentially other cancers.

Detailed description

Optimize the novel 3D organoid technique already used to recreate hematologic tumors. Optimize cell viability of hematologic cancer organoids to extend available time in culture by screening cell culture media cytokines and 3D extracellular matrix composition. Evaluate hematologic tumor composition at different time points to confirm accurate tumor representation and identify genetic expression characteristics, unique mutations, and tumor-stroma interaction. These aspects of tumor interaction with its stromal microenviroment will provide critical knowledge to better understand its biology. Evaluate chemosensitivity on patient derived 3D organoids. Using marrow aspirate from participants with hematologic malignancies, evaluate live/kill rates of hematologic cancer cells after being exposed to established regimen combinations after 24 and 36 hours of exposure at pre-determined concentrations. Using participant samples, evaluate differences in gene expression and cell markers of the hematologic cancer cells that remained alive after chemotherapy exposure to better understand mechanisms of resistance. Validate the predictive value of the 3D organoid chemotherapy sensitivity results compared with retrospective data of the donor's responses to the treatment used at that time point. This will compare in vivo/ex vivo responses and facilitate future personalized medicine.

Conditions

• Hematologic Malignancy

Interventions

Type	Name	Description
OTHER	Ancillary-Correlative - Creation of three-dimensional myeloma organoids using marrow aspirates	Bone marrow aspirates will be collected from participants with hematologic malignancy being evaluated for relapsed disease to create three-dimensional constructs using a three-dimensional bioprinting methodology for automated organoid biofabrication.

Timeline

• Start date: 2019-05-16
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2019-03-26
• Last updated: 2026-03-20

Locations

1 site across 1 country: United States