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

  • End date
    Mar 12, 2024
  • participants needed
  • sponsor
Updated on 27 January 2021
drug screening
precision medicine


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.


  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.

Condition Malignant neoplasm of prostate, Prostate Cancer, Prostate Cancer, Early, Recurrent, Pancreatic Cancer, Pancreatic Cancer, Islet Ce417ll Cancer, Alveolar Cell Carcinoma, Bronchiolo-Alveolar Carcinoma (BAC), Pulmonary Disease, Lung Disease, Cervical Cancer, Cervical Cancer, Bile duct carcinoma, Adenocarcinoma, Malignant Adenoma, Adenocarcinoma, Colorectal Cancer, Colorectal Cancer, Colon Cancer Screening, Colon cancer; rectal cancer, Disorders of cervix NOS, Connective and Soft Tissue Neoplasm, Solid Tumors, All Solid Tumors, Cholangiocarcinoma, Malignant neoplasm of kidney, Kidney Cancer, Renal Cancer, Rectal Cancer, Rectal Cancer, Oligodendroglioma, Disorder of uterus NOS, Uterine Disorders, Uterine Cancer, Uterine Cancer, Pancreatic disorder, Pancreatic Disorders, bladder cancer, bladder cancer, Bladder Carcinoma, Urothelial Cancer, Glioma, Gliomas, Malignant neoplasm of adrenal gland, Adrenal Cancer, Breast Cancer, Breast Cancer, LIVER DISEASE, LIVER DISEASE, Liver Disorders, Carcinoma, Vulvar Dysplasia and Carcinoma, Advanced Malignancies, Esophageal Diseases, Esophageal Disorders, Esophageal Cancer, Esophageal Cancer, Laryngeal Cancer, Glioblastoma Multiforme, Glioblastoma Multiforme, Malignant neoplasm of colon, Colon Cancer, melanoma, Malignant Melanoma, Metastatic Melanoma, melanoma, Neoplasms, Unknown Primary, Squamous cell carcinoma, Squamous cell carcinoma, Transitional cell carcinoma, Urothelial Carcinoma, Renal Cell Carcinoma, Renal Cell Carcinoma, Renal Cell Cancer, Lung Neoplasm, Lung Cancer, skin cancer, skin cancer, HEPATIC NEOPLASM, Liver Cancer, Neoplasm of unspecified nature of digestive system, Digestive System Neoplasms, Small Cell Lung Cancer, Small Cell Lung Cancer, Sarcoma, Sarcoma, Sarcoma (Pediatric), Soft Tissue Sarcoma, HEPATOCELLULAR CARCINOMA, Gastropathy, Stomach Discomfort, Gastric Cancer, Gastric Cancer, Stomach Cancer, gastrointestinal stromal tumor, Anal Cancer, head and neck cancer, head and neck cancer, Malignant neoplasm of testis, Testicular Cancer, Stomach Discomfort, Pancreatic Disorders, Metastatic Melanoma, Vulvar Dysplasia and Carcinoma, All Solid Tumors, Colon Cancer Screening, Prostate Cancer, Early, Recurrent, Solid Tumors, Colon cancer; rectal cancer, Advanced Cancer, Esophageal Carcinoma, Other Cancer, Breast Cancer Diagnosis, Urothelial Cancer, Lung Adenocarcinoma, Laryngeal Carcinoma, Gastric Carcinoma, Advanced Malignancies, Cancer of Brain and Nervous System, Bronchiolo-Alveolar Carcinoma (BAC), Sarcoma (Pediatric), Islet Ce417ll Cancer, Kidney Cancer, Lung Cancer, Colon Cancer, Prostate Cancer, Testicular Cancer, Esophageal Disorders, Malignant Melanoma, Liver Cancer, Malignant Adenoma, Lung Disease, Stomach Cancer, Adrenal Cancer, Gliomas, Uterine Disorders, Liver Disorders, Biliary Tract Cancer, Renal Cell Cancer, Renal Cancer, Digestive System Neoplasms, Soft Tissue Sarcoma, Bladder Carcinoma, Urothelial Carcinoma, Cancer Metastatic, Adenocarcinoma Lung, Cancer, All Types, Cancer of Vulva, Disseminated, Cancer, Advanced, Cancer, Other, Cancer Cords Vocal, Cancers Cell Neuroendocrine, Cancer Differentiated Poorly, Cancer, Anaplastic Thyroid, Cancer, All Types, Cancer of Vulva, Disseminated, Cancer, Advanced, Cancer, Other, Cancer, Anaplastic Thyroid, Cancer, All Types, Cancer of Vulva, Disseminated, Cancer, Advanced, Cancer, Other, Cancer, Anaplastic Thyroid, Cancer, All Types, Cancer of Vulva, Disseminated, Cancer, Advanced, Cancer, Other, Cancer, Anaplastic Thyroid, breast carcinoma, cervical carcinoma, clear cell renal cell carcinoma, neck cancer, prostate carcinoma, other malignancy, cancer other, glioblastoma, cancer advanced, cancer of the bile duct, gastric cancers, gastrointestinal stromal tumors, gist, sarcomas, soft tissue sarcomas, cancer, breast, esophagus cancer, oesophageal cancer, cancer, liver, cancer, hepatic, cancer, hepatocellular, liver cancers, cancer of the head and neck, skin cancers, cervical cancer, uterine, cancer of the pancreas, bronchoalveolar carcinoma, cancers metastatic, carcinoma of the cervix uteri, carcinoma of the cervix, cervix cancer, cancer of the cervix, carcinoma of cervix, cancer, renal, epidermoid carcinoma, squamous cell cancer, prostate cancers, pancreatic cancers, cancer, pancreatic, liver cell carcinoma, sclc, small cell carcinoma, small cell carcinoma of the lung, cancer of the esophagus, oesophageal carcinoma, carcinoma lung, lung carcinoma, testis cancer, rectal carcinoma, Cancer, All Types, Cancer of Vulva, Disseminated, Cancer, Anaplastic Thyroid, Cancer, All Types, Cancer of Vulva, Disseminated, Cancer, Anaplastic Thyroid, Cancer, All Types, Cancer of Vulva, Disseminated, Cancer, Anaplastic Thyroid
Clinical Study IdentifierNCT03896958
Last Modified on27 January 2021


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Inclusion Criteria

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

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