Renal Cell CarcinomaNCT04309617
Retrospective Study on Referral Patterns for High Risk Patients Post Nephrectomy
An observational study of Renal Cell Carcinoma, run by Pfizer at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- nephrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 618 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2019to 28 Apr 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 years or older who were diagnosed with locoregional RCC and underwent nephrectomy at Duke
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Provider Referral Patterns Following Nephrectomy in High-Risk Locoregional Renal Cell Carcinoma
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
- Being tested
- nephrectomy
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nephrectomyProcedure or surgery
Surgery performed within the study period
| Study group | Role | What they receive |
|---|---|---|
| patients with Renal Cell Carcinoma(RCC) | Patients diagnosed with RCC who received a nephrectomy between 01Apr2014 and 31Mar2019 Receives: Procedure: nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From nephrectomy up to disease recurrence, approximately during 5 years (data observed during 9 months of retrospective study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start31 Jul 2019
- Primary completion28 Apr 2020
- Study completion28 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 618 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309617
- Sponsor's protocol ID
- A6181230
- Status last verified
- Apr 2021
- First submitted
- 13 Mar 2020
- Last updated
- 19 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Publications
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.
PubMed 34751002
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Provider Referral Patterns Following Nephrectomy in High-Risk Locoregional Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04309617
- Acronym / sponsor ID
- A6181230
- Conditions
- Renal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 618 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 28 Apr 2020 (actual)
- Study completion
- 28 Apr 2020 (actual)
- First posted
- 16 Mar 2020 (actual)
- Results
- Posted 19 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with Renal Cell Carcinoma(RCC) | – | Procedure: nephrectomyPatients diagnosed with RCC who received a nephrectomy between 01Apr2014 and 31Mar2019 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or older who were diagnosed with locoregional RCC and underwent nephrectomy at Duke
Key inclusion criteria (4 listed)
- Patients must meet all of the following inclusion criteria to be eligible for data abstraction:
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nephrectomySurgery performed within the study period | Procedure or surgery | patients with Renal Cell Carcinoma(RCC) |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34751002Dzimitrowicz 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04309617, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.