NCT02732860

Personalized Patient Derived Xenograft (pPDX) Modeling to Test Drug Response in Matching Host

Prospective Evaluation of Freshly Implanted Cancers in Mice to Test Drug Response in Matching Host

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

By obtaining clinical specimens from participants with triple negative breast cancer (TNBC), colorectal cancer (CRC), high grade serous ovarian cancer (HGSOC), and other select tumor types to establish and profile as freshly implanted tumors in mice, the aim of this study is to identify agents with predicted activity in the host patient while also potentially providing them with personalized cancer treatment options

Detailed description

Personalized patient-derived xenografts (pPDX) are increasingly used as tools for drug development in pre-clinical settings, and have been shown to recapitulate the histology and behavior of the cancers from which they are derived. Although, they have been commonly used productively as pre-clinical disease models to study disease biology and drug response, they have not been used prospectively to inform clinical management. pPDX have been employed to inform clinical decision-making in small studies, which have shown high concordance between individual pPDX and patient responses to therapy. While encouraging, the role of this approach in breast, colorectal, ovarian, and other cancer populations and in the context of genomic drug matching strategies remains undefined. This has created an opportunity to evaluate the utility of pPDX as clinical predictors to direct the use of chemo- and targeted therapies in combination with comprehensive genomic and epigenetic analysis for patients with TNBC, CRC, HGSOC and other selected tumor types.

Conditions

• Colorectal Neoplasms
• Colorectal Cancer
• Breast Cancer
• Breast Neoplasms
• Ovarian Cancer
• Ovarian Neoplasm

Interventions

Type	Name	Description
OTHER	Molecular Profiling & In Vivo drug testing in pPDX and organoid cultures	Molecular profiling of host tumour sample and pPDX will be performed and analyzed by an expert panel. In vitro organoid culture generation may also be performed if sufficient fresh tissue is available. Matched treatment recommendation based on profiling and in vivo pPDX drug testing results will be made, if available. This recommendation will be communicated to the primary oncologist.

Timeline

• Start date: 2015-12-01
• Primary completion: 2026-01-04
• Completion: 2026-01-04
• First posted: 2016-04-11
• Last updated: 2025-01-30

Locations

1 site across 1 country: Canada