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Clinical Trial 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).


Clinical Trial 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 Design


Related Conditions & MeSH terms

  • Adenocarcinoma Lung
  • Adenocarcinoma of Lung
  • Adenocarcinoma, Bronchiolo-Alveolar
  • Adrenal Cancer
  • Adrenal Gland Neoplasms
  • Bile Duct Neoplasms
  • Brain Neoplasms
  • Breast Cancer
  • Bronchoalveolar Cell Lung Cancer
  • Cancer Cords Vocal
  • Cancer Differentiated Poorly
  • Cancer of Brain and Nervous System
  • Cancer of Cervix
  • Cancer of Colon
  • Cancer of Esophagus
  • Cancer of Head and Neck
  • Cancer of Kidney
  • Cancer of Larynx
  • Cancer of Liver
  • Cancer of Lung
  • Cancer of Neck
  • Cancer of Pancreas
  • Cancer of Prostate
  • Cancer of Rectum
  • Cancer of Stomach
  • Cancer of Vulva, Disseminated
  • Cancer Skin
  • Cancer Unknown Primary
  • Cancer, Advanced
  • Cancer, All Types
  • Cancer, Anal
  • Cancer, Anaplastic Thyroid
  • Cancer, Bile Duct
  • Cancer, Bladder
  • Cancer, Metastatic
  • Cancer, Other
  • Cancers Cell Neuroendocrine
  • Carcinoma
  • Carcinoma, Renal Cell
  • Carcinoma, Transitional Cell
  • Cholangiocarcinoma
  • Colonic Neoplasms
  • Esophageal Neoplasms
  • GIST
  • Glioblastoma
  • Glioblastoma Multiforme
  • Head and Neck Neoplasms
  • Hepatocellular Carcinoma
  • Kidney Neoplasms
  • Laryngeal Neoplasms
  • Liver Neoplasms
  • Lung Neoplasms
  • Melanoma
  • Neoplasms, Unknown Primary
  • Oligodendroglioma
  • Pancreatic Neoplasms
  • Prostatic Neoplasms
  • Rectal Neoplasms
  • Renal Cell Carcinoma
  • Sarcoma
  • Small Cell Lung Carcinoma
  • Small-cell Lung Cancer
  • Squamous Cell Carcinoma
  • Stomach Neoplasms
  • Testicular Cancer
  • Testicular Neoplasms
  • Thyroid Carcinoma, Anaplastic
  • Transitional Cell Carcinoma
  • Urinary Bladder Neoplasms
  • Uterine Cancer
  • Uterine Cervical Neoplasms
  • Uterine Neoplasms
  • Vulvar Neoplasms

NCT number NCT03896958
Study type Observational
Source SpeciCare
Contact Leah Streuber, BS
Phone 6782960815
Email leah.streuber@specicare.com
Status Recruiting
Phase
Start date March 21, 2019
Completion date March 12, 2024

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