Clinical trial · Observational
A Study to go Back Into Records and Observe How People With Metastatic Renal Cell Carcinoma (mRCC) Who Received a Medicine Called Sunitinib Responded to This Medicine.
A Retrospective Registry Based Study for Evaluating Treatment Response in Patients Targeted Treated With Metastatic Renal Cell Carcinoma (mRCC) With Sunitinib in First-line Therapy
- 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 purpose of this study is to understand how patients with mRCC respond to the study medicine (called sunitinib) when they receive it as the first line of treatment after finding out the cause for the disease. This study will look into how different and how well groups of people with high chances of developing the disease respond to the study medicine. All data for this study will be anonymously extracted from data already entered in RCC Registry which is owned by Turkish Oncology Group Association (TOGD). This study will pull out records from the Registry between 01-Mar-2019 and 30-Oct-2022 that belongs to people: * who are Turkish citizens * who are older than 18 years * who were found out to have mRCC * who received sunitinib as the first line treatment after finding out the cause for the disease This study will look at the responses, experiences and how long the patients use the study medicine sunitinib.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Clear-cell Metastatic Renal Cell Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sunitinib | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- metastatic Renal Cell Carcinoma patients
- description
- metastatic Renal Cell Carcinoma patients with clear cell histology.
- interventionNames
- Drug: Sunitinib
Primary outcomes (4)
- measure
- Objective Response Rate (ORR) According to Disease Risk Group in IMDC
- timeFrame
- From initiation of sunitinib treatment (retrospective data) till PR and CR or death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
- description
- ORR: percentage of participants with partial response (PR) and complete response (CR). As per response evaluation criteria in solid tumors (RECIST)1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. IMDC assessed as favorable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present (KPS \<80%; time from diagnosis to start of systemic therapy \<1 year; corrected serum calcium \[Ca\]; neutrophils and platelets \>ULN; hemoglobin \[hg\] \<LLN).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Being a Turkish citizen. * Being older than 18 years-old. * Being clinically diagnosed with mRCC and treated. * Being treated with Sunitinib in first line Exclusion Criteria: * Patients whose treatment was initiated but excluded from follow-up for any reason.
References
Publications (0)
Data not yet available