Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients
NCT01934452
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Adult Trials: 18+ Years
- 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
- Sunitinib administered in a non-approved label
- For cases: CR occurring without sunitinib treatment
- For controls: Prior systemic treatment
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| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title | Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients | ||||
| Official Title | ANALYSE PROSPECTIVE DES REMISSIONS COMPLETES OBSERVEES SOUS SUNITINIB CHEZ DES PATIENTS ATTEINTS D'UN CANCER DU REIN METASTATIQUE (MRCC) | ||||
| Brief Summary | 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?) | ||||
| Detailed Description | The main objective of the study is to describe the characteristics of mRCC patients on CR with Sunitinib (Cases) and compare them to the characteristics of mRCC patients non on CR (controls) in order to identify factors associated with the occurrence of complete remission. The results obtained on the sample must be representative of the population targeted by the study. The most appropriate method to obtain a representative sample is probability sampling. A sample size of N = 40 (cases) and N = 80 (Controls) will provide a power of 80% in the detection of a frequency difference between cases and controls corresponding to an OR of 0.24 for a parameter frequency 10% in control arm and an OR of 0.30 for a parameter frequency of around 30% in control arm. The significance level was set at bilateral 5%. The data will be analyzed using SAS software (version 9.1 - SAS Institute, North Carolina, United States). | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: whole blood and serum | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | complete remission in mRCC patients treated with sunitinib versus non complete remission in mRCC patients treated with sunitinib | ||||
| Condition | Complete Remission in Renal Cell Carcinoma | ||||
| Intervention |
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment | 120 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 1, 2021 | ||||
| Estimated Primary Completion Date | December 1, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 99 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT01934452 | ||||
| Other Study ID Numbers | NRA6180080 A6181209 ( Other Identifier: Alias Study Number ) | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement |
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| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Pfizer | ||||
| Verification Date | April 2020 | ||||