Clinical trial · Observational
Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients
Prospective Study of Complete Remissions Observed With Sunitinib in Patients With Metastatic Renal Cell Carcinoma mRCC)
- 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 prospective study will investigate the characteristics of mRCC patients at time of CR in comparison with mRCC patients non on CR treated with Sunitinib, in order to provide some answers/ refection leads to the following questions : Can we identify blood specificity at time of CR vs non on CR? Shall we distinguish CR with sunitinib alone from combined CR (sunitinib with local treatment), while in clinical report these 2 cohorts present similar time to recurrence (ALBIGES, ASCO 2010)? Can we identify potential predictive serum biomarkers of recurrence? (With the aim of isolating blood biomarker that can help on treatment discontinuation decision?)
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 |
|---|---|---|---|
| Complete Remission in Renal Cell Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sunitinib | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Complete Remission
- description
- Complete remission arm in mRCC patients treated with sunitinib.
- interventionNames
- Drug: sunitinib
- label
- Non Complete Remission
- description
- Non complete remission arm in mRCC patients treated with sunitinib.
- interventionNames
- Drug: sunitinib
Primary outcomes (60)
- measure
- Time to Diagnose Metastatic Renal Cell Carcinoma
- timeFrame
- Baseline (at inclusion Visit)
- description
- Time to diagnose metastatic renal cell carcinoma was defined as the duration between date of diagnosis of mRCC to date of inclusion visit.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with metastatic renal cell carcinoma, histopathologically confirmed * Treated with sunitinib according to Smpc * For cases: Achieving a CR (local assessment according to RECIST V1.0 criteria) with Sunitinib in prior 6 months alone OR in combination with local treatment (surgery, radiation therapy, ablative techniques: cryotherapy, RFA) * For controls: Life expectancy \> 3 months No prior Sunitinib treatment * Patient \>18 years Exclusion Criteria: * Sunitinib administered in a non-approved label * For cases: CR occurring without sunitinib treatment * For controls: Prior systemic treatment
References
Publications (0)
Data not yet available