
The PIONEER Initiative: Precision Insights On N-of-1 Ex Vivo Effectiveness Research Based on Individual Tumor Ownership (Precision Oncology)
Study Purpose
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).
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
Eligible Ages | 1 Month - 99 Years |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03896958 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
SpeciCare |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Ken Dixon, MD |
Principal Investigator Affiliation | SpeciCare |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry, Other |
Overall Status | Unknown status |
Countries | United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
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 |
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.