Clinical trial · Observational
The PIONEER Initiative: Precision Insights On N-of-1 Ex Vivo Effectiveness Research Based on Individual Tumor Ownership (Precision Oncology)
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (45)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma Lung | Lung Adenocarcinoma | ALIAS | 0.90 |
| Adrenal Cancer | Malignant Adrenal Gland Neoplasm | ALIAS | 0.90 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Bronchoalveolar Cell Lung Cancer | — | UNRESOLVED | — |
| Cancer, Advanced | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Cancer, All Types | Malignant Neoplasm | ALIAS | 0.85 |
| Cancer, Anal | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| Cancer, Anaplastic Thyroid | Thyroid Gland Anaplastic Carcinoma |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Return of research information
- timeFrame
- Two Years
- description
- 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
- measure
- Assessment of benefit of return of research results
- timeFrame
- Two Years
- description
- 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.
- measure
- Assessment of benefit of return of research results by SpeciCare Outcome Monitor Board
- timeFrame
- Two Years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available