The PIONEER Initiative: Precision Insights On N-of-1 Ex Vivo Effectiveness Research Based on Individual Tumor Ownership (Precision Oncology)
PIONEER
1 other identifier
observational
1,000
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 21, 2019
CompletedFirst Submitted
Initial submission to the registry
March 26, 2019
CompletedFirst Posted
Study publicly available on registry
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2024
CompletedDecember 4, 2020
December 1, 2020
5 years
March 26, 2019
December 2, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Return of research information
Monitor the ability to return research and study information back to the individual patient and cancer care team over time. We will calculate the % of patients that carry out additional genomic testing, % of patients that carry out additional functional precision testing, and % of clinicians that report that they altered their clinical therapeutic regiments based upon these results
Two Years
Assessment of benefit of return of research results
Survey of study subjects and physicians as to the benefit or not of access to this additional data in attempting to improve upon standard of care of the day. We will calculate this as a % of patients.
Two Years
Assessment of benefit of return of research results by SpeciCare Outcome Monitor Board
The primary mission of our team is to assess benefit of patient tissue ownership and functional testing to the standard of care process. We will calculate this as a % of patients.
Two Years
Eligibility Criteria
The primary target study group is all patients with a cancer serious enough to put the patient at risk of morbidity or death.
You may qualify if:
- \- All patients diagnosed with cancer and all patients at risk of cancer
You may not qualify if:
- Patients who decline definitive therapies Patients with comorbidities that prevent definitive therapies Patients on hospice
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SpeciCarelead
- Georgia Institute of Technologycollaborator
- Predictive Oncologycollaborator
- University of Washingtoncollaborator
- Netnoidscollaborator
- Northeast Georgia Hospital Systemcollaborator
Study Sites (1)
Specicare
Gainesville, Georgia, 30501, United States
Biospecimen
Biospecimens are saved in fresh and cryopreserved state. Also, FFPE, DNA, and RNA extraction.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ken Dixon, MD
SpeciCare
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2019
First Posted
April 1, 2019
Study Start
March 21, 2019
Primary Completion
March 12, 2024
Study Completion
March 12, 2024
Last Updated
December 4, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- Within six months of completion of study and/or publication of data driven by the study.
- Access Criteria
- SpeciCare has a data access committee, to which researchers can apply and receive data pending approval of this committee.
Data will be shared with strategic partners with appropriate IRB vetting.