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

NCT ID: NCT03896958

Last Updated: 2020-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-21

Study Completion Date

2024-03-12

Brief Summary

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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).

Detailed Description

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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.

Conditions

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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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Georgia Institute of Technology

OTHER

Sponsor Role collaborator

Predictive Oncology

UNKNOWN

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

Netnoids

UNKNOWN

Sponsor Role collaborator

Northeast Georgia Hospital System

UNKNOWN

Sponsor Role collaborator

SpeciCare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ken Dixon, MD

Role: PRINCIPAL_INVESTIGATOR

SpeciCare

Locations

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Specicare

Gainesville, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Leah Streuber, BS

Role: CONTACT

Phone: 6782960815

Email: [email protected]

Patrick deGrouchy, BA

Role: CONTACT

Phone: 4848320331

Email: [email protected]

Facility Contacts

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Ken Dixon, MD

Role: primary

Patrick deGrouchy, BA

Role: backup

Other Identifiers

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MYCT001

Identifier Type: -

Identifier Source: org_study_id