A Retrospective Real World Analysis Of Sutent In Patients With Metastatic Renal Cell Carcinoma In Community And Academic Centers To Assess The Impact Of Dose Variation On Duration Of Response And Overall Survival
NCT01917214
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Adult Trials: 18+ Years
- Age >18
- Male or female
- Metastatic renal cell cancer
- First presentation with metastatic disease prior to 1st Jan 2012 since 2006, i.e. between 1st Jan 2006 to 31st Dec 2011
- No referral to medical oncologist
- No record available in electronic database
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | A Retrospective Real World Analysis Of Sutent In Patients With Metastatic Renal Cell Carcinoma In Community And Academic Centers To Assess The Impact Of Dose Variation On Duration Of Response And Overall Survival | |||
| Official Title | Patterns Of Care Among Australian Cohort Of Patients With Advanced Rrc Receiving Sutent | |||
| Brief Summary | This is a retrospective, non-interventional study which looks at the cohort of Renal Cell Carcinoma patients in a real life clinical setting and analyses into factors why these patients have been surviving for as long as 3-5 years unlike Clinical study where the survival is around 2 years. The factors which will be analysed include patient characteristics, dosage and adverse event management and tries to correlate these factors with survival. | |||
| Detailed Description | A single cohort of 200 patients who are diagnosed with metastatic renal cell carcinoma prior to 1st Jan 2012, and are seen by the medical oncologist at the centers involved with BIOGRID and its affiliated registries. Patients will be identified from the first date of their consultation with the medical oncologist and captured in the electronic database. Consent to use datasets has already been obtained from participating research institutes and hospitals IRB/Ethics Committees | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case-Only Time Perspective: Retrospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | All subjects who are diagnosed with metastatic renal cell carcinoma | |||
| Condition | Metastatic Renal Cell Carcinoma | |||
| Intervention | Other: Sutent: Observational Study
Sutent oral therapy | |||
| Study Groups/Cohorts | Non-Interventional Study
Intervention: Other: Sutent: Observational Study | |||
| 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 | Completed | |||
| Actual Enrollment | 212 | |||
| Original Estimated Enrollment | 200 | |||
| Actual Study Completion Date | March 2014 | |||
| Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT01917214 | |||
| Other Study ID Numbers | A6181210 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | March 2015 | |||