Retrospective Study on Referral Patterns for High Risk Patients Post Nephrectomy

NCT04309617

Last updated date
Study Location
Duke University
Durham, North Carolina, 27710, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
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

- Patients must meet all of the following inclusion criteria to be eligible for data abstraction:

- Diagnosed with locoregional RCC (no distant metastasis at the time of diagnosis)

- Underwent a nephrectomy at Duke between 01 April 2014, and 31 December 2019 (final dates determined based on results from part 2 data collection)

- Aged 18 years or older at nephrectomy

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


- none

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Advanced Information
Descriptive Information
Brief Title Retrospective Study on Referral Patterns for High Risk Patients Post Nephrectomy
Official Title Provider Referral Patterns Following Nephrectomy in High-Risk Locoregional Renal Cell Carcinoma
Brief Summary This study aims at estimating the proportion of patients diagnosed with locoregional renal cell carcinoma who are at high risk for recurrence following nephrectomy, describe referral patterns, and characterize treatment in this population. Outcomes including estimation of the incidence of recurrence and disease-free interval following nephrectomy will be reported overall and among the subgroup off patients receiving adjuvant systemic therapy with sunitinib following nephrectomy.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients aged 18 years or older who were diagnosed with locoregional RCC and underwent nephrectomy at Duke
Condition Renal Cell Carcinoma
Intervention Procedure: nephrectomy
Surgery performed within the study period
Study Groups/Cohorts patients with Renal Cell Carcinoma(RCC)
Patients diagnosed with RCC who received a nephrectomy between 01Apr2014 and 31Mar2019
Intervention: Procedure: nephrectomy
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
 (submitted: July 28, 2020)
618
Original Estimated Enrollment
 (submitted: March 13, 2020)
500
Actual Study Completion Date April 28, 2020
Actual Primary Completion Date April 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients must meet all of the following inclusion criteria to be eligible for data abstraction:

    • Diagnosed with locoregional RCC (no distant metastasis at the time of diagnosis)
    • Underwent a nephrectomy at Duke between 01 April 2014, and 31 December 2019 (final dates determined based on results from part 2 data collection)
    • Aged 18 years or older at nephrectomy

Exclusion Criteria:

  • none
Sex/Gender
Sexes Eligible for Study:All
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04309617
Other Study ID Numbers A6181230
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2020