Clinical trial NCT04309617: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-03-16
Enrollment: 618
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 years or older who were diagnosed with locoregional RCC and underwent nephrectomy at Duke

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.


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

Primary outcomes:
measure: Follow-up Duration
timeFrame: From index date to the last entry in the medical record, death, or disease recurrence, approximately during 5 years (data observed during 9 months of retrospective study)
measure: Number of Participants Classified According to Follow-up Plan Determined at First Post-operative Visit
timeFrame: At first post-nephrectomy visit during approximately during 5 years (data observed during 9 months of retrospective study)
measure: Number of Participants With Transfer of Care to a Non-Duke Provider
timeFrame: At first post-nephrectomy visit during approximately during 5 years (data observed during 9 months of retrospective study)
measure: Number of Participants With no Documented Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group
timeFrame: Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)
measure: Number of Participants Classified According to Type of Referring Provider for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group
timeFrame: Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)
measure: Number of Participants Classified According to Type of Provider Referred to for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group
timeFrame: Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)
measure: Number of Participants Classified According to Reasons for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group
timeFrame: Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)
measure: Time to Any Referral for Oncologic/Renal Cell Carcinoma (RCC) Related Care: Modified High Risk Sub-group
timeFrame: Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)
measure: Time From Nephrectomy to Subsequent Surgery: Modified High Risk Sub-group
timeFrame: From nephrectomy up to the subsequent surgery, approximately during 5 years (data observed during 9 months of retrospective study)
measure: Number of Participants Classified According to Type of Subsequent Surgery: Modified High Risk Sub-group
timeFrame: From nephrectomy up to the subsequent surgery, approximately during 5 years (data observed during 9 months of retrospective study)
measure: Time From Nephrectomy to Receipt of First-line Adjuvant Systemic Therapy (AST): Modified High Risk Sub-group
timeFrame: From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study)
measure: Number of Participants Classified According to Type of Systemic Agents Received as First-line AST: Modified High Risk Sub-group
timeFrame: From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study)
measure: Mean of Starting Dose of First-line AST Received: Modified High Risk Sub-group
timeFrame: From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study)
measure: 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
timeFrame: From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study)
measure: Number of Participants Classified According to First-line AST Discontinuation Reasons: Modified High Risk Sub-group
timeFrame: From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study)
measure: RCC Related Follow-up Duration After Nephrectomy: Modified High Risk Sub-group
timeFrame: From nephrectomy up to the follow-up, approximately during 5 years (data observed during 9 months of retrospective study)
measure: Number of Participants Who Died: Modified High Risk Sub-group
timeFrame: From nephrectomy up to death by any cause, approximately during 5 years (data observed during 9 months of retrospective study)
measure: Number of Participants Classified According to Type of Disease Recurrence: Modified High Risk Sub-group
timeFrame: From nephrectomy up to disease recurrence, approximately during 5 years (data observed during 9 months of retrospective study)
measure: Time From Nephrectomy to Recurrence: Modified High Risk Sub-group
timeFrame: From nephrectomy up to disease recurrence, approximately during 5 years (data observed during 9 months of retrospective study)
Secondary outcomes:
Other outcomes:
measure: Disease Free Survival (DFS): Modified High Risk Sub-group
timeFrame: From nephrectomy up to earliest documentation of high-risk of recurrence or death, approximately during 5 years (data observed during 9 months of retrospective study)
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Dzimitrowicz H, Esterberg E, Miles L, Zanotti G, Borham A, Harrison MR. Referral and adjuvant treatment patterns after nephrectomy in high-risk locoregional renal cell carcinoma. Cancer Med. 2021 Dec;10(24):8891-8898. doi: 10.1002/cam4.4407. Epub 2021 Nov 9.