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NCT03896958: PIONEER

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

Status unknown Last updated 4 December 2020
What this trial tests

trial in Cancer, All Types in 1,000 participants. Status unknown.

Timeline
21 March 2019
Primary endpoint
12 March 2024
12 March 2024

Quick facts

Lead sponsorSpeciCare
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment1,000
Start date21 March 2019
Primary completion12 March 2024
Estimated completion12 March 2024
Sites1 location across United States

Conditions studied

Sponsor

SpeciCare

Who can join

Adults 1 Month to 99, any sex, with Cancer, All Types or Cancer of Liver. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Functional precision oncology: Testing tumors with drugs to identify vulnerabilities and novel combinations.
    Letai A, Bhola P, Welm AL. · · 2022 · cited 182× · PMID 34951956 · DOI 10.1016/j.ccell.2021.12.004
  2. Predictive Biomarkers of Response to Neoadjuvant Chemotherapy in Breast Cancer: Current and Future Perspectives for Precision Medicine.
    Derouane F, van Marcke C, Berlière M, Gerday A, et al · · 2022 · cited 54× · PMID 36010869 · DOI 10.3390/cancers14163876
  3. Patient derived organoids in prostate cancer: improving therapeutic efficacy in precision medicine.
    Pamarthy S, Sabaawy HE. · · 2021 · cited 44× · PMID 34587953 · DOI 10.1186/s12943-021-01426-3
  4. Clinical Epigenetics of Neuroendocrine Tumors: The Road Ahead.
    Colao A, de Nigris F, Modica R, Napoli C. · · 2020 · cited 31× · PMID 33384663 · DOI 10.3389/fendo.2020.604341
  5. Patient-Derived Tumor Organoids for Drug Repositioning in Cancer Care: A Promising Approach in the Era of Tailored Treatment.
    Vivarelli S, Candido S, Caruso G, Falzone L, et al · · 2020 · cited 29× · PMID 33291603 · DOI 10.3390/cancers12123636
  6. Applications of organoid technology to brain tumors.
    Wen J, Liu F, Cheng Q, Weygant N, et al · · 2023 · cited 26× · PMID 37248629 · DOI 10.1111/cns.14272
  7. Lung Cancer Organoids: The Rough Path to Personalized Medicine.
    Rossi R, De Angelis ML, Xhelili E, Sette G, et al · · 2022 · cited 21× · PMID 35954367 · DOI 10.3390/cancers14153703
  8. The Potential Clinical Use of Stem/Progenitor Cells and Organoids in Liver Diseases.
    Nikokiraki C, Psaraki A, Roubelakis MG. · · 2022 · cited 17× · PMID 35563716 · DOI 10.3390/cells11091410

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03896958.

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