Retrospective Study on Referral Patterns for High Risk Patients Post Nephrectomy
NCT04309617
Last updated date
ABOUT THIS STUDY
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.
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
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
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 | 618 | ||||
| Original Estimated Enrollment | 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:
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 | 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 |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | July 2020 | ||||