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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

Last updated on December 4, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- No referral to medical oncologist

- No record available in electronic database

NCT01917214
Pfizer
Completed
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

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Descriptive Information
Brief TitleA 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 TitlePatterns 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 DescriptionA 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 TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationAll subjects who are diagnosed with metastatic renal cell carcinoma
ConditionMetastatic Renal Cell Carcinoma
InterventionOther: Sutent: Observational Study
Sutent oral therapy
Study Groups/CohortsNon-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 StatusCompleted
Actual Enrollment
 (submitted: March 13, 2015)
212
Original Estimated Enrollment
 (submitted: August 2, 2013)
200
Actual Study Completion DateMarch 2014
Actual Primary Completion DateMarch 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • No referral to medical oncologist
  • No record available in electronic database
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01917214
Other Study ID NumbersA6181210
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2015

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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