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Retrospective Study on Referral Patterns for High Risk Patients Post Nephrectomy

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ClinicalTrials.gov Identifier: NCT04309617
Recruitment Status : Completed
First Posted : March 16, 2020
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment
Renal Cell Carcinoma Procedure: nephrectomy

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Study Type : Observational
Actual Enrollment : 618 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Provider Referral Patterns Following Nephrectomy in High-Risk Locoregional Renal Cell Carcinoma
Actual Study Start Date : July 31, 2019
Actual Primary Completion Date : April 28, 2020
Actual Study Completion Date : April 28, 2020


Group/Cohort Intervention/treatment
patients with Renal Cell Carcinoma(RCC)
Patients diagnosed with RCC who received a nephrectomy between 01Apr2014 and 31Mar2019
Procedure: nephrectomy
Surgery performed within the study period




Primary Outcome Measures :
  1. Describe patient demographic and clinical characteristics of patients diagnosed with locoregional RCC who underwent nephrectomy [ Time Frame: 01Apr2014 to 31Mar2019 ]
  2. Proportion of patients at high risk of recurrence following nephrectomy [ Time Frame: 01Apr2014 to 31Mar2019 ]
  3. Proportion of high risk patients who received additional provider referral and reasons for referral [ Time Frame: 01Apr2014 to 31Mar2019 ]
  4. Proportion of patients who received systemic therapy by type, dose and duration of treatment [ Time Frame: 01Apr2014 to 31Mar2019 ]
  5. Proportion of patients who discontinued sytemic therapy treatment for any reason [ Time Frame: 01Apr2014 to 31Mar2019 ]
  6. Proportion of patients who may have participated in a clinical trial [ Time Frame: 01Apr2014 to 31Mar2019 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 18 years or older who were diagnosed with locoregional RCC and underwent nephrectomy at Duke
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04309617


Locations
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United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04309617    
Other Study ID Numbers: A6181230
First Posted: March 16, 2020    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (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/data_requests.
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases