The PIONEER Initiative: Precision Insights On N-of-1 Ex Vivo Effectiveness Research Based on Individual Tumor Ownership (Precision Oncology)

Summary

The PIONEER Initiative stands for Precision Insights On N-of-1 Ex vivo Effectiveness Research. The PIONEER Initiative is designed to provide access to functional precision medicine to any cancer patient with any tumor at any medical facility. Tumor tissue is saved at time of biopsy or surgery in multiple formats, including fresh and cryopreserved as a living biospecimen. SpeciCare assists with access to clinical records in order to provide information back to the patient and the patient's clinical care team. The biospecimen tumor tissue is stored in a bio-storage facility and can be shipped anywhere the patient and the clinical team require for further testing. Additionally, the cryopreservation of the biospecimen allows for decisions about testing to be made at a later date. It also facilitates participation in clinical trials. The ability to return research information from this repository back to the patient is the primary end point of the study. The secondary end point is the subjective assessment by the patient and his or her physician as to the potential benefit that this additional information provides over standard of care. Overall the goal of PIONEER is to enable best in class functional precision testing of a patient's tumor tissue to help guide optimal therapy (to date this type of analysis includes organoid drug screening approaches in addition to traditional genomic profiling).

Conditions

• Cancer, All Types
• Cancer of Liver
• Cancer of Stomach
• Cancer of Head and Neck
• Cancer of Rectum
• Cancer of Kidney
• Cancer of Esophagus
• Cancer of Colon
• Cancer Skin
• Cancer of Cervix
• Cancer, Metastatic
• Cancer of Larynx
• Cancer of Neck
• Cancer of Lung
• Cancer of Brain and Nervous System
• Cancer of Vulva, Disseminated
• Cancer of Pancreas
• Sarcoma
• GIST
• Small-cell Lung Cancer
• Adenocarcinoma Lung
• Cancer of Prostate
• Cancer, Advanced
• Adrenal Cancer
• Testicular Cancer
• Uterine Cancer
• Bronchoalveolar Cell Lung Cancer
• Cancer Unknown Primary
• Glioblastoma Multiforme
• Oligodendroglioma
• Breast Cancer
• Renal Cell Carcinoma
• Hepatocellular Carcinoma
• Cholangiocarcinoma
• Squamous Cell Carcinoma
• Transitional Cell Carcinoma
• Cancer, Other
• Cancer, Anal
• Melanoma
• Cancer, Bile Duct
• Cancer, Bladder
• Cancer Cords Vocal
• Cancers Cell Neuroendocrine
• Cancer Differentiated Poorly
• Cancer, Anaplastic Thyroid

Sponsors & Collaborators

• Georgia Institute of Technology

  collaborator OTHER

• Predictive Oncology

  collaborator UNKNOWN

• University of Washington

  collaborator OTHER

• Netnoids

  collaborator UNKNOWN

• Northeast Georgia Hospital System

  collaborator UNKNOWN

• SpeciCare

  lead INDUSTRY

Principal Investigators

• Ken Dixon, MD · SpeciCare

Eligibility

Min Age

1 Month

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-21

Primary Completion

2024-03-12

Completion

2024-03-12

Countries

• United States

Study Locations