An observational study in Cancer, All Types, Cancer of Liver and Cancer of Stomach, sponsored by SpeciCare. Status unknown at 1 site in United States. Open to participants aged 1 Month to 99 Years. Per ClinicalTrials.gov, last updated 2020-12-04.
Sponsored by SpeciCare · Observational
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).
The PIONEER Initiative is a lead clinical trial designed to provide the foundation for subsequent adaptive trials. The mission with this and subsequent trial activity will be to demonstrate the utility of carrying out functional precision medicine in that cohort of patients who receive local cancer care at institutions that do not have significant research capabilities or are not NCI-designated cancer centers. As discussed above, the vast majority of cancer patients (\~85%) are in this category. It is imperative to open up the possibility of best-in-class functional precision medicine testing to these patients. Core aspects of the PIONEER Initiative include recruiting a cadre of up to 200 patients, showing that proof of concept in a more limited set of patients can ultimately scale to arbitrarily large numbers of patients. It is anticipated that PIONEER will continue as the foundation for subsequent clinical trials into the indefinite future. This evolving trial structure fills an important unmet need within the broader cancer community since the primary mission is the return of actionable information in order to positively impact care.
The underlying basic assumption of the PIONEER Initiative is that the ability to receive the best in cancer care should not be restricted as to location, age, or medical condition. The PIONEER Initiative design facilitates inclusion of subjects across all these divides, thus providing beneficence to all participants. A key aspect of the PIONEER Initiative is to provide patient benefit through a data and tissue biorepository to be utilized by researchers to discover new cancer diagnostics, treatment therapies and preventive strategies. Additionally, the data and samples will be used to improve existing treatments and to understand, at the molecular level, changes occurring during transition from illness to remission and/or relapse. SpeciCare, through the PIONEER Initiative, will store de-identified self-reported data, medical records, and biological samples from individuals who consent to participate in PIONEER. PIONEER will obtain further study and testing as appropriate and return results, through CLIA certified labs, through research vetted by CLIA testing, and, as enabled by current regulatory standards, through delivery of research results back to the patient and patient's clinical care team.
SPECIFIC OBJECTIVES
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 200 across 2,638 observational studies indexed under Neoplasms.
Browse Neoplasms studies →This is the only study on the registry with SpeciCare as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The primary target study group is all patients with a cancer serious enough to put the patient at risk of morbidity or death.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
-Patients who decline definitive therapies Patients with comorbidities that prevent definitive therapies Patients on hospice
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
Time frame: 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.
Time frame: 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.
Time frame: Two Years
Plan to share: Yes — Data will be shared with strategic partners with appropriate IRB vetting.
Supporting information: Study protocol, Informed consent form, Clinical study report
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.
No publications or documents are linked to this record.
Started Mar 2019 (actual). Primary completion is estimated for Mar 2024, 59 months after the start.
Of 148 industry-sponsored observational studies under Neoplasms, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 102. This study's planned 59 months is above that.
Counting every sponsor, half of 1,246 studies reached it within 58 months; a quarter within 24 and three quarters within 210.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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