N/A
N=618
Retrospective Study on Referral Patterns for High Risk Patients Post Nephrectomy
Renal Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT04309617 ↗Enrolled (actual)
618
Serious AEs
—
Results posted
May 2021
Primary outcome: Primary: Follow-up Duration — 1.07 years
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- nephrectomy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Follow-up Duration |
1.07 | — |
| PRIMARY Number of Participants Classified According to Follow-up Plan Determined at First Post-operative Visit |
519; 25; 5; 3 | — |
| PRIMARY Number of Participants With Transfer of Care to a Non-Duke Provider |
36 | — |
| PRIMARY Number of Participants With no Documented Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group |
88 | — |
| PRIMARY Number of Participants Classified According to Type of Referring Provider for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group |
31; 0; 0 | — |
| PRIMARY Number of Participants Classified According to Type of Provider Referred to for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group |
29; 0; 0; 1; 1 | — |
| PRIMARY Number of Participants Classified According to Reasons for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group |
25; 2; 4 | — |
| PRIMARY Time to Any Referral for Oncologic/Renal Cell Carcinoma (RCC) Related Care: Modified High Risk Sub-group |
50.00 | — |
| PRIMARY Time From Nephrectomy to Subsequent Surgery: Modified High Risk Sub-group |
11.90 | — |
| PRIMARY Number of Participants Classified According to Type of Subsequent Surgery: Modified High Risk Sub-group |
1; 0; 4 | — |
| PRIMARY Time From Nephrectomy to Receipt of First-line Adjuvant Systemic Therapy (AST): Modified High Risk Sub-group |
82.00 | — |
| PRIMARY Number of Participants Classified According to Type of Systemic Agents Received as First-line AST: Modified High Risk Sub-group |
1; 2 | — |
| PRIMARY Mean of Starting Dose of First-line AST Received: Modified High Risk Sub-group |
125.00 | — |
| PRIMARY Number of Participants Who Were Treated With First-line AST as Part of a Clinical Trial in the Adjuvant Setting: Modified High Risk Sub-group |
2 | — |
| PRIMARY Number of Participants Classified According to First-line AST Discontinuation Reasons: Modified High Risk Sub-group |
1; 1 | — |
| PRIMARY RCC Related Follow-up Duration After Nephrectomy: Modified High Risk Sub-group |
1.57 | — |
| PRIMARY Number of Participants Who Died: Modified High Risk Sub-group |
15 | — |
| PRIMARY Number of Participants Classified According to Type of Disease Recurrence: Modified High Risk Sub-group |
4; 38 | — |
| PRIMARY Time From Nephrectomy to Recurrence: Modified High Risk Sub-group |
5.72 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04309617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.