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

December 2, 2020 updated by: SpeciCare

The PIONEER Initiative: Precision Insights On N-of-1 Effectiveness Research. Tissue Ownership by the Individual With the Return of Actionable Information to the Individual Patient and Physician (Precision Oncology)

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).

Study Overview

Status

Recruiting

Conditions

Detailed Description

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

  1. To establish a data and tissue biobank comprised of high quality biological specimens and associated clinical data that will support drug discovery, diagnostic assay development, oncology biomarker discovery, molecular biology, immuno-oncology therapies, translational medicine and other future discoveries as novel methods become available.
  2. To facilitate and accelerate oncology research, including genetic research (e.g. whole genome sequencing), by providing a pipeline of high quality specimens and associated clinical data for researchers to access.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 99 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The primary target study group is all patients with a cancer serious enough to put the patient at risk of morbidity or death.

Description

Inclusion Criteria:

- All patients diagnosed with cancer and all patients at risk of cancer

Exclusion Criteria:

-Patients who decline definitive therapies Patients with comorbidities that prevent definitive therapies Patients on hospice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Return of research information
Time Frame: Two Years
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
Time Frame: Two Years
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
Time Frame: Two Years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SpeciCare

Collaborators

University of Washington
Georgia Institute of Technology
Predictive Oncology
Netnoids
Northeast Georgia Hospital System

Investigators

  • Principal Investigator: Ken Dixon, MD, Specicare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 21, 2019

Primary Completion (ANTICIPATED)

March 12, 2024

Study Completion (ANTICIPATED)

March 12, 2024

Study Registration Dates

First Submitted

March 26, 2019

First Submitted That Met QC Criteria

March 28, 2019

First Posted (ACTUAL)

April 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 4, 2020

Last Update Submitted That Met QC Criteria

December 2, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MYCT001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared with strategic partners with appropriate IRB vetting.

IPD Sharing Time Frame

Within six months of completion of study and/or publication of data driven by the study.

IPD Sharing Access Criteria

SpeciCare has a data access committee, to which researchers can apply and receive data pending approval of this committee.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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