Retrospective Study on Referral Patterns for High Risk Patients Post Nephrectomy

Renal Cell Carcinoma Clinical Trial

Official title:

Provider Referral Patterns Following Nephrectomy in High-Risk Locoregional Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04309617
• Other study ID #: A6181230
• Status: Completed
• Start date: July 31, 2019
• Est. completion date: April 28, 2020

Study information

• Verified date: April 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 618
• Est. completion date: April 28, 2020
• Est. primary completion date: April 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Procedure:
• nephrectomy
Surgery performed within the study period

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disease Free Survival (DFS): Modified High Risk Sub-group	DFS was defined as the time interval (in months) from date of nephrectomy to earliest documentation of high-risk of RCC recurrence or death. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.	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)
Primary	Follow-up Duration	Follow- up time (in years) was duration between index date to the last entry in the medical record, death, or disease recurrence. The date of nephrectomy was considered as index date.	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)
Primary	Number of Participants Classified According to Follow-up Plan Determined at First Post-operative Visit	In this outcome measure number of participants were classified according to their follow-up plan determined at first post-operative visit. Follow-up plans were as follows: 1) surveillance, 2) adjuvant systemic therapy (AST), 3) follow-up plan not recorded in the medical record and 4) other.	At first post-nephrectomy visit during approximately during 5 years (data observed during 9 months of retrospective study)
Primary	Number of Participants With Transfer of Care to a Non-Duke Provider	In this outcome measure number of participants with transfer of care to a non-Duke provider were reported.	At first post-nephrectomy visit during approximately during 5 years (data observed during 9 months of retrospective study)
Primary	Number of Participants With no Documented Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group	Among number of participants who were followed up for any referral, those participants who had no documented oncologic/RCC related care referrals were recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.	Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)
Primary	Number of Participants Classified According to Type of Referring Provider for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group	Number of participants according to the type of provider who referred for oncologic or RCC related care after nephrectomy were recorded and reported. Type of providers included urologist, primary care, and other. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.	Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)
Primary	Number of Participants Classified According to Type of Provider Referred to for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group	Number of participants according to the type of provider referred to, for oncologic/RCC related care after nephrectomy were recorded and reported. Type of providers to whom participants were referred included medical oncologist, radiation oncologist, urologist, interventional radiologist, and medical geneticist. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.	Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)
Primary	Number of Participants Classified According to Reasons for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group	Number of participants according to reasons for being referred to oncologic or RCC related care after nephrectomy were recorded and reported. Reasons included discussion of adjuvant systemic therapy (AST) options, other discussion of management options, and other. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.	Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)
Primary	Time to Any Referral for Oncologic/Renal Cell Carcinoma (RCC) Related Care: Modified High Risk Sub-group	After nephrectomy, time (in days) to any referral for oncologic or RCC related care was recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.	Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)
Primary	Time From Nephrectomy to Subsequent Surgery: Modified High Risk Sub-group	Time from nephrectomy (in months) up to the subsequent surgery was recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.	From nephrectomy up to the subsequent surgery, approximately during 5 years (data observed during 9 months of retrospective study)
Primary	Number of Participants Classified According to Type of Subsequent Surgery: Modified High Risk Sub-group	Number of participants according to the type of subsequent surgery after nephrectomy were reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.	From nephrectomy up to the subsequent surgery, approximately during 5 years (data observed during 9 months of retrospective study)
Primary	Time From Nephrectomy to Receipt of First-line Adjuvant Systemic Therapy (AST): Modified High Risk Sub-group	Time from nephrectomy up to the first-line AST was recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.	From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study)
Primary	Number of Participants Classified According to Type of Systemic Agents Received as First-line AST: Modified High Risk Sub-group	Number of participants according to type of systemic agents received as first-line AST were recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.	From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study)
Primary	Mean of Starting Dose of First-line AST Received: Modified High Risk Sub-group	Mean of starting dose of first-line AST received after nephrectomy was reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.	From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study)
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	In this outcome measure number of participants who were treated with first-line AST after nephrectomy as a part of clinical trial in adjuvant setting were reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.	From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study)
Primary	Number of Participants Classified According to First-line AST Discontinuation Reasons: Modified High Risk Sub-group	In this outcome measure number of participants were classified according to reason for discontinuation of treatment with first-line AST after nephrectomy. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.	From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study)
Primary	RCC Related Follow-up Duration After Nephrectomy: Modified High Risk Sub-group	RCC related follow-up duration after nephrectomy was reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.	From nephrectomy up to the follow-up, approximately during 5 years (data observed during 9 months of retrospective study)
Primary	Number of Participants Who Died: Modified High Risk Sub-group	Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.	From nephrectomy up to death by any cause, approximately during 5 years (data observed during 9 months of retrospective study)
Primary	Number of Participants Classified According to Type of Disease Recurrence: Modified High Risk Sub-group	Number of participants according to the type of disease recurrence are reported. Type of disease recurrence were locoregional and distant. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.	From nephrectomy up to disease recurrence, approximately during 5 years (data observed during 9 months of retrospective study)
Primary	Time From Nephrectomy to Recurrence: Modified High Risk Sub-group	Time from nephrectomy to recurrence (in months) was defined as the time from nephrectomy to the high risk of RCC recurrence or end of participant record or receipt of systemic therapy or death due to any cause. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.	From nephrectomy up to disease recurrence, approximately during 5 years (data observed during 9 months of retrospective study)

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