Retrospective Study on Referral Patterns for High Risk Patients Post Nephrectomy

NCT04309617 | Completed Results

• 1 other identifier: A6181230
• Study Type: observational
• Target: 618
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (19)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Other Outcomes (1)

• Disease Free Survival (DFS): 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)

Study Arms (1)

patients with Renal Cell Carcinoma(RCC)

Patients diagnosed with RCC who received a nephrectomy between 01Apr2014 and 31Mar2019

Procedure: nephrectomy

Interventions

nephrectomy PROCEDURE

Surgery performed within the study period

patients with Renal Cell Carcinoma(RCC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 years or older who were diagnosed with locoregional RCC and underwent nephrectomy at Duke

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• 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.

  PMID: 34751002 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Nephrectomy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 16, 2020
• Study Start: July 31, 2019
• Primary Completion: April 28, 2020
• Study Completion: April 28, 2020
• Last Updated: May 19, 2021
• Results First Posted: May 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)