Clinical trial · Observational
Master Protocol to Study Treatment Patterns, Medication Adherence, Health and Economic Outcomes and Unmet Needs in RCC
Study of Advanced Renal Cell Carcinoma Treatment Patterns and Unmet Needs Using Real World Claims and Electronic Medical Record Data.
NCT04375150CI-TRIAL-00080793completedResults postedClinicalTrials.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)
The study aims to assess treatment patterns and outcomes in advanced RCC patients in real world clinical practices across various real world databases. Four databases will be evaluated
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 |
|---|---|---|---|
| Renal Cell Carcinoma (RCC) | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immuno-oncology (IO) | Drug | — | UNRESOLVED |
| Tyrosine kinase inhibitor (TKI) | Drug | Tyrosine Kinase Inhibitor | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Patients with advanced renal cell carcinoma (RCC)
- interventionNames
- Drug: Tyrosine kinase inhibitor (TKI)
- Drug: Immuno-oncology (IO)
Primary outcomes (17)
- measure
- Number of Participants With First Line Treatment Regimen
- timeFrame
- At index (anytime between 1-Apr-2018 and 31-Jul-2022 [approximately 52 months]); data collected and observed retrospectively over 35 months
- description
- Number of participants with first line treatment regimen prescribed following a primary and secondary diagnosis of advanced/metastatic disease is reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
- measure
- Number of Participants With Monotherapy and Combination Therapy
- timeFrame
- From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Age 20 years or older in the year of the index first line therapy prescription. * 2 or more RCC diagnoses (ICD-9: 189.0; ICD-10: C64.1, C64.2, C64.9) at least 30 days apart, in the 1 year prior to the index date until 30 days post index date. * 2 or more code for secondary malignancy codes indicating possible diagnoses for metastatic disease at least 30 days apart, in the 1 year prior to the index date until 30 days post index date. (ICD-9: xx-199.xx; ICD-10: C77-C79, except ICD9: 198.0 Secondary malignant neoplasm of the kidney and ICD10: C79.0 Secondary malignant neoplasm of the kidney and renal pelvis.) * Exploratory sensitivity analyses were performed to review patients with 1 or more diagnosis codes for advanced or metastatic RCC 12 months prior to the index date and 1 or more secondary malignancy codes around the RCC diagnosis dates. * Continuous enrollment from 12 months prior to the index date. Patients will be required to have continuous enrollment from their index date until the end of the available data. This will allow for sub-analysis of cohorts with 3 months, 6 months and 12 months of available data Exclusion Criteria: * Received advanced treatment prior to the study index date. * Prescription records with negative days of supply will be excluded from all the analyses except in cost variable calculation. The day of supply for claims with missing or 0 days will be imputed. * Only one RCC diagnosis in the 12 months prior or one mont post index date. * Patients with data for analysis (\< 3 months post index date)
References
Publications (0)
Data not yet available
No reference posted for this study.