NCT04309617

Retrospective Study on Referral Patterns for High Risk Patients Post Nephrectomy

Completed Results posted Last updated 19 May 2021

What this trial tests

trial testing nephrectomy in Renal Cell Carcinoma in 618 participants. Completed in 28 April 2020.

Timeline

31 July 2019

Primary endpoint
28 April 2020

28 April 2020

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	618
Start date	31 July 2019
Primary completion	28 April 2020
Estimated completion	28 April 2020
Sites	1 location across United States

Drugs / interventions tested

• nephrectomy

Conditions studied

• Renal Cell Carcinoma — all drugs for Renal Cell Carcinoma →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Follow-up Duration Primary · 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)

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.

Group	Value	95% CI
All Participants	1.07	0.00 – 4.87

Number of Participants Classified According to Follow-up Plan Determined at First Post-operative Visit Primary · At first post-nephrectomy visit during approximately during 5 years (data observed during 9 months of retrospective study)

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.

Group	Value	95% CI
All Participants	519
All Participants	25
All Participants	5
All Participants	3

Number of Participants With Transfer of Care to a Non-Duke Provider Primary · At first post-nephrectomy visit during approximately during 5 years (data observed during 9 months of retrospective study)

In this outcome measure number of participants with transfer of care to a non-Duke provider were reported.

Group	Value	95% CI
All Participants	36

Number of Participants With no Documented Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group Primary · Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)

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.

Group	Value	95% CI
Participants at Modified High Risk for Recurrence	88

Number of Participants Classified According to Type of Referring Provider for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group Primary · Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)

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.

Group	Value	95% CI
Participants at Modified High Risk for Recurrence	31
Participants at Modified High Risk for Recurrence	0
Participants at Modified High Risk for Recurrence	0

Number of Participants Classified According to Type of Provider Referred to for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group Primary · Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)

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.

Group	Value	95% CI
Participants at Modified High Risk for Recurrence	29
Participants at Modified High Risk for Recurrence	0
Participants at Modified High Risk for Recurrence	0
Participants at Modified High Risk for Recurrence	1

Number of Participants Classified According to Reasons for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group Primary · Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)

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.

Group	Value	95% CI
Participants at Modified High Risk for Recurrence	25
Participants at Modified High Risk for Recurrence	2
Participants at Modified High Risk for Recurrence	4

Time to Any Referral for Oncologic/Renal Cell Carcinoma (RCC) Related Care: Modified High Risk Sub-group Primary · Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)

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.

Group	Value	95% CI
Participants at Modified High Risk for Recurrence	50.00	16.00 – 812.00

Time From Nephrectomy to Subsequent Surgery: Modified High Risk Sub-group Primary · From nephrectomy up to the subsequent surgery, approximately during 5 years (data observed during 9 months of retrospective study)

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.

Group	Value	95% CI
Participants at Modified High Risk for Recurrence	11.90	3.21 – 22.02

Number of Participants Classified According to Type of Subsequent Surgery: Modified High Risk Sub-group Primary · From nephrectomy up to the subsequent surgery, approximately during 5 years (data observed during 9 months of retrospective study)

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.

Group	Value	95% CI
Participants at Modified High Risk for Recurrence	1
Participants at Modified High Risk for Recurrence	0
Participants at Modified High Risk for Recurrence	4

Time From Nephrectomy to Receipt of First-line Adjuvant Systemic Therapy (AST): Modified High Risk Sub-group Primary · From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study)

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.

Group	Value	95% CI
Participants at Modified High Risk for Recurrence	82.00	76.00 – 117.00

Number of Participants Classified According to Type of Systemic Agents Received as First-line AST: Modified High Risk Sub-group Primary · From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study)

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.

Group	Value	95% CI
Participants at Modified High Risk for Recurrence	1
Participants at Modified High Risk for Recurrence	2

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Referral and adjuvant treatment patterns after nephrectomy in high-risk locoregional renal cell carcinoma.
   Dzimitrowicz H, Esterberg E, Miles L, Zanotti G, et al · · 2021 · cited 3× · PMID 34751002 · DOI 10.1002/cam4.4407