The PIONEER Initiative: Precision Insights On N-of-1 Ex Vivo Effectiveness Research Based on Individual Tumor Ownership (Precision Oncology) (PIONEER)
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|ClinicalTrials.gov Identifier: NCT03896958|
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
|Condition or disease|
|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|
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.
- To provide patient access to additional information about his or her tumor, including functional precision cancer testing outside the patient's body, in order to provide potential access to clinical trials, decreased toxicities, better outcomes, improved overall care compared with the current standard, and potentially improved survival.
- To establish a data and tissue biorepository 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.
- To facilitate and accelerate oncology research by providing a pipeline of high quality specimens and associated clinical data for researchers to access.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||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)|
|Actual Study Start Date :||March 21, 2019|
|Estimated Primary Completion Date :||March 12, 2021|
|Estimated Study Completion Date :||March 12, 2021|
- 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
- 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.
- 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896958
|Contact: Ken Dixon, MD||7708618747 ext firstname.lastname@example.org|
|Contact: Patrick deGrouchy, BAemail@example.com|
|Study Chair:||Fredrik Vannberg, DPhil||SpeciCare|