Clinical trial · Observational
The Registry of Oncology Outcomes Associated With Testing and Treatment
The Registry of Oncology Outcomes Associated With Testing and Treatment (ROOT)
NCT04028479CI-TRIAL-00083887ROOTcompletedClinicalTrials.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 to collect and validate regulatory-grade real-world data (RWD) in oncology using the novel, Master Observational Trial construct. This data can be then used in real-world evidence (RWE) generation. It will also create reusable infrastructure to allow creation or affiliation with many additional RWD/RWE efforts both prospective and retrospective in nature.
Conditions
Conditions (76)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Adenocystic Carcinoma | Adenoid Cystic Carcinoma | ALIAS | 0.90 |
| Adrenal Cancer | Malignant Adrenal Gland Neoplasm | ALIAS | 0.90 |
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| Appendix Cancer | Malignant Appendix Neoplasm | ALIAS | 0.90 |
| Astrocytoma | Astrocytoma | CURATED_BROADER | 0.80 |
| Bile Duct Cancer | Malignant Bile Duct Neoplasm | CURATED_BROADER |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biomarker Testing (L) | Diagnostic Test | — | UNRESOLVED |
| Patient Reported Outcomes (P) | Other | — | UNRESOLVED |
| Systemic Treatment (T) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Validation Cohort
- description
- Patients enrolled into the study to allow validation of a specific element, process, or endpoint. Validation will be done showing concordance with traditional interventional trial standards.
- interventionNames
- Diagnostic Test: Biomarker Testing (L)
- Drug: Systemic Treatment (T)
- label
- Analysis Cohorts
- description
- Patient who are enrolled into the study to allow analysis to determine any association, effect, or benefit. Cohorts can be determined prospectively and/or retrospectively for data already collected, Cohorts are identified to highlight collection of information on patients who are already receiving any treatment or testing as determined by the physician and patient independent of this study. Because many analysis cohorts will be determined in patients already enrolled in the study, this group is inclusive of many different sub-groupings or specific analysis cohorts of patients.
- interventionNames
- Diagnostic Test: Biomarker Testing (L)
- Drug: Systemic Treatment (T)
- Other: Patient Reported Outcomes (P)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient or representative provides written informed consent * Patient is diagnosed with advanced malignancy * Patient is willing to be treated for this malignancy according to a plan determine by them and their physician * patient will be willing to have regular follow up visits as part of their standard of care Exclusion Criteria: * patient is not a candidate or does not desire any treatment for their disease
References
Publications (9)
- BACKGROUNDWoodcock J, LaVange LM. Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both. N Engl J Med. 2017 Jul 6;377(1):62-70. doi: 10.1056/NEJMra1510062. No abstract available. PMID 28679092
- BACKGROUNDBoland JF, Chung CC, Roberson D, Mitchell J, Zhang X, Im KM, He J, Chanock SJ, Yeager M, Dean M. The new sequencer on the block: comparison of Life Technology's Proton sequencer to an Illumina HiSeq for whole-exome sequencing. Hum Genet. 2013 Oct;132(10):1153-63. doi: 10.1007/s00439-013-1321-4. Epub 2013 Jun 12. PMID 23757002
- BACKGROUNDMorash M, Mitchell H, Beltran H, Elemento O, Pathak J. The Role of Next-Generation Sequencing in Precision Medicine: A Review of Outcomes in Oncology. J Pers Med. 2018 Sep 17;8(3):30. doi: 10.3390/jpm8030030. PMID 30227640
- BACKGROUNDKorphaisarn K, Kopetz S. BRAF-Directed Therapy in Metastatic Colorectal Cancer. Cancer J. 2016 May-Jun;22(3):175-8. doi: 10.1097/PPO.0000000000000189. PMID 27341594
- BACKGROUNDSherman RE, Anderson SA, Dal Pan GJ, Gray GW, Gross T, Hunter NL, LaVange L, Marinac-Dabic D, Marks PW, Robb MA, Shuren J, Temple R, Woodcock J, Yue LQ, Califf RM. Real-World Evidence - What Is It and What Can It Tell Us? N Engl J Med. 2016 Dec 8;375(23):2293-2297. doi: 10.1056/NEJMsb1609216. No abstract available. PMID 27959688
- BACKGROUNDKaplan RM, Chambers DA, Glasgow RE. Big data and large sample size: a cautionary note on the potential for bias. Clin Transl Sci. 2014 Aug;7(4):342-6. doi: 10.1111/cts.12178. Epub 2014 Jul 15. PMID 25043853
- BACKGROUNDAACR Project GENIE Consortium. AACR Project GENIE: Powering Precision Medicine through an International Consortium. Cancer Discov. 2017 Aug;7(8):818-831. doi: 10.1158/2159-8290.CD-17-0151. Epub 2017 Jun 1. PMID 28572459