Clinical trial · Observational
Umbrella Study for Analysis of Data Related to Patients With Cancer
NCT06018753CI-TRIAL-00116141PolariscompletedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study is a multisite, minimal risk, non-interventional study using patient electronic health record data collected as part of standard of care to answer cohort-based research questions and create robust real-world data sets.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Patients with cancer
- description
- No intervention or sample collection is required on the study.
Primary outcomes (5)
- measure
- Provide RWD/E Datasets to Research Collaborators to Support Development
- timeFrame
- 5 years
- description
- Use data analysis to enable deeper understanding of patient population characteristics and outcomes to more accurately assess clinical trial feasibility and optimize trial design.
- measure
- Provide RWD/E Datasets to Research Collaborators to Support Regulatory
- timeFrame
- 5 years
- description
- Use data analysis to generate supplemental data for new accelerated approval pathway filings and provide real world control arms where necessary.
- measure
- Provide RWD/E Datasets to Research Collaborators to Support Commercialization
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Subjects must be diagnosed with cancer * Medical records available to meet cohort requirements Exclusion Criteria: \- None
References
Publications (4)
- BACKGROUNDThomas M. Pharma and the benefits of Real World Data. Drug Discovery World (DDW). Published November 4, 2021. Accessed May 5, 2023. https://www.ddw-online.com/trends-analysis-pharma-and-the-benefits-of-real-world-data-13702-202111/
- BACKGROUNDOffice of the Commissioner. Oncology Real World Evidence Program. U.S. Food and Drug Administration. Accessed May 5, 2023. https://www.fda.gov/about-fda/oncology-center-excellence/oncology-real-world-evidence-program
- BACKGROUNDGrayson N. Real-world data can help make better drugs and do it faster. STAT. Published May 2, 2018. Accessed May 5, 2023. https://www.statnews.com/2018/05/02/real-world-data-drug-development/
- BACKGROUNDRudrapatna VA, Butte AJ. Opportunities and challenges in using real-world data for health care. J Clin Invest. 2020 Feb 3;130(2):565-574. doi: 10.1172/JCI129197. PMID 32011317