NCT05338073

KM3D Multicenter Cancer Consortium: Predicting Patient Response Using 3D Cell Culture Models

KM3D Multicenter Cancer Consortium Study: Validation of In Vitro 3D Cell Culture Models for Tumor Drug Sensitivity After Tissue Removal

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Known Medicine, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the ability of the Known Medicine platform to predict the efficacy of certain cancer drug treatments and to validate that tumor organoid drug sensitivity is representative of patient treatment outcomes.

Detailed description

This is a non-interventional clinical study in which (1) cancer tissue that has been resected, biopsied, or drained due to malignant pleural effusion and that is left remaining after (or is not being used during) a pathology investigation and, where possible, (2) a vial of the same patient's blood is sent to Known Medicine Inc. for placement into organoids and subsequent tumor drug sensitivity measurement. Patients will be consented prior to performance of a medically indicated and pre-planned surgical procedure during which at least a 1cm3 piece of tumor tissue or \>100 mL pleural effusion fluid and blood in a separate vial are obtained. These samples will be sent after removal to Known Medicine Inc. from the hospital using a kit provided by Known Medicine. Within the Known Medicine provided kit a data form, freezer pack and containers for the specimens will be provided. If a solid tissue sample, the tissue will be washed and subsequently digested into a single cell solution using enzymatic digestion methods. Cells will be sorted into cancer and stromal cell populations, stained fluorescently with intramembrane stain, and placed into a 3D cell culture matrix within a multi-well plate. Cells may also be genetically sequenced. If an aspirated fluid sample, cells will be separated from the fluid and further sorted into cancer cell populations. Cultures will be allowed to sustain themselves for 48 hours, at which point standard of care chemotherapeutic or other FDA approved drug treatments will be administered. After 72 hours, control and treated wells will be imaged using fluorescence and cell phenotype will be evaluated. Media from cultures may also be evaluated. After imaging, media will be removed and a metabolic assay will be performed to determine culture viability. Using the described quantitative outcomes, tumor sensitivity to each of the administered treatments will be determined. Patients will be followed and their response to treatment and outcome information from the hospital will be obtained which will allow retrospective validation of tumor organoid sensitivity.

Conditions

• Cancer
• Predictive Cancer Model
• Effects of Chemotherapy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Known 3Dx Test	Cancer tissue is cultured and treated with a panel of FDA approved chemotherapy and targeted therapies at a range of doses. Cell growth and phenotypes are measured to determine which treatment or treatment combinations would yield the best results for a patient. Test results are compared to actual patient outcomes collected at 3, 6, 9, and 12 months post tissue collection to determine the predictive power of the Known 3Dx Test

Timeline

• Start date: 2021-01-12
• Primary completion: 2025-01-31
• Completion: 2026-01-31
• First posted: 2022-04-20
• Last updated: 2023-04-24

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study