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Completed

NCT Number: NCT04309617

Retrospective Study on Referral Patterns for High Risk Patients Post Nephrectomy

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nephrectomy

Procedure

Surgery performed within the study period

Primary outcomes

  1. Follow-up Duration

    Time frame: 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.

  2. Number of Participants Classified According to Follow-up Plan Determined at First Post-operative Visit

    Time frame: 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.

  3. Number of Participants With Transfer of Care to a Non-Duke Provider

    Time frame: 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.

  4. Number of Participants With no Documented Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group

    Time frame: 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.

  5. Number of Participants Classified According to Type of Referring Provider for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group

    Time frame: 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.

  6. Number of Participants Classified According to Type of Provider Referred to for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group

    Time frame: 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.

  7. Number of Participants Classified According to Reasons for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group

    Time frame: 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.

  8. Time to Any Referral for Oncologic/Renal Cell Carcinoma (RCC) Related Care: Modified High Risk Sub-group

    Time frame: 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.

  9. Time From Nephrectomy to Subsequent Surgery: Modified High Risk Sub-group

    Time frame: 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.

  10. Number of Participants Classified According to Type of Subsequent Surgery: Modified High Risk Sub-group

    Time frame: 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.

  11. Time From Nephrectomy to Receipt of First-line Adjuvant Systemic Therapy (AST): Modified High Risk Sub-group

    Time frame: 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.

  12. Number of Participants Classified According to Type of Systemic Agents Received as First-line AST: Modified High Risk Sub-group

    Time frame: 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.

  13. Mean of Starting Dose of First-line AST Received: Modified High Risk Sub-group

    Time frame: 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 after nephrectomy was reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.

  14. 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

    Time frame: From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study)

    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.

  15. Number of Participants Classified According to First-line AST Discontinuation Reasons: Modified High Risk Sub-group

    Time frame: From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study)

    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.

  16. RCC Related Follow-up Duration After Nephrectomy: Modified High Risk Sub-group

    Time frame: From nephrectomy up to the follow-up, approximately during 5 years (data observed during 9 months of retrospective study)

    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.

  17. Number of Participants Who Died: Modified High Risk Sub-group

    Time frame: From nephrectomy up to death by any cause, approximately during 5 years (data observed during 9 months of retrospective study)

    Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.

  18. Number of Participants Classified According to Type of Disease Recurrence: Modified High Risk Sub-group

    Time frame: From nephrectomy up to disease recurrence, approximately during 5 years (data observed during 9 months of retrospective study)

    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.

  19. Time From Nephrectomy to Recurrence: Modified High Risk Sub-group

    Time frame: From nephrectomy up to disease recurrence, approximately during 5 years (data observed during 9 months of retrospective study)

    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.

Other outcomes

  1. Disease Free Survival (DFS): Modified High Risk Sub-group

    Time frame: 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)

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 16, 2020
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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