Carcinoma, Renal CellNCT01381601
Incidence, Prevalence, and Symptom Burden Associated With Advanced Renal Cell Carcinoma in Commercially Insured Population (Pharmetrics)
An observational study of Carcinoma, Renal Cell, run by GlaxoSmithKline.
Trial summary
Information on the prevalence of advanced/metastatic renal cell carcinoma and its symptom burden is limited in commercially insured adult patients. Additionally, limited information exists on economic burden of adverse events associated with treatments for advanced/metastatic renal cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Targeted agents indicated in management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib)
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Study subjects will be selected from a source population consisting of all persons in the PharMetrics database with one or more days of eligibility for comprehensive health benefits between January 1, 2000 and December 31, 2009.
Who may be able to join
- two or more medical encounters with a diagnosis of kidney cancer (ICD-9-CM 189.0) or malignant neoplasm of the renal pelvis (189.1), and
- two or more medical encounters with a diagnosis of distant secondary malignant neoplasm (ICD-9-CM 197.XX-199.0, excluding 198.0 [kidney metastasis]) on different days <120 days apart (the date of the earliest such encounter will be designated the "index date").
Who cannot join
- evidence of receipt of chemotherapeutic agents indicated or used in the treatment of advanced TCC, or
- evidence of cystoscopy, biopsy of the bladder, or radical cystectomy
- evidence of any other primary cancer
About this study
Information on the prevalence of advanced/metastatic renal cell carcinoma and its symptom burden is limited in commercially insured adult patients. Additionally, limited information exists on economic burden of adverse events associated with treatments for advanced/metastatic renal cell carcinoma. An objective of the current study is to estimate the incidence, prevalence, and symptom burden associated with advanced/metastatic RCC in a US "real-world" setting. Another objective is to quantify the economic burden of severe adverse events with agents used in management of first line advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib). This study will employ a retrospective cohort design. Analyses of health insurance claims data from a large commercially insured population will be employed in the current study. Study subjects will consist of all persons, aged ≥18 years, with evidence of advanced RCC between January 1, 2000 and December 31, 2009; these persons will be identified based in part on case-ascertainment algorithms. Analyses will be directed at estimating annual rates of incidence and prevalence of advanced/metastatic RCC, as well as symptom burden and costs of common severe adverse events associated with treatments used in management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib).
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Targeted agents indicated in management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib)
- Keywords
- retrospective database analysis, economic burden
- Medical subject headings
- Carcinoma, Renal Cell, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted agents indicated in management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib)Drug
Also called VOTRIENT™ (pazopanib), SUTENT® (sunitinib malate), AVASTIN® (bevacizumab), NEXAVAR® (sorafenib)
Metastatic RCC patients on either sunitinib or sorafenib or bevacizumab or pazopanib (identified based on claims) will be evaluated for presence or absence of common severe adverse events. These common severe adverse events will be identified from agent's product labels.
| Study group | Role | What they receive |
|---|---|---|
| Severe adverse event claims in subjects with metastatic RCC | Presence or absence of common severe treatment related adverse events (based on existence of claims) in patients with metastatic RCC. Common severe adverse event defined as Grade 3 or higher with >=5% frequency of occurence as reported in product label. Receives: Drug: Targeted agents indicated in management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
New and existing claims of metastatic renal cell carcinoma across multiple years
Identifying new and existing claims (based on claims based case-ascertainment algorithm) of metastatic renal cell carcinoma across multiple years
Measured: 2000 - 2009 (up to 10 years)
Cost associated with management of common severe adverse events related to 1st line treatments used in metastatic renal cell carcinoma
Quantifying economic burden associated with management of common severe adverse events (defined as grade 3 and above adverse events occurring >= 5% as per product label) related to agents used in 1st line metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib). Adverse events will be identified based on product labels.
Measured: 2000 - 2009 (up to 10 years)
Secondary outcomes (1)
Quantify symptom burden associated with metastatic renal cell carcinoma
Quantifying symptom burden based on identification of claims associated with the respective symptoms. Disease related symptoms will be identified based on published literature.
Measured: 2000 - 2009 (up to 10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381601
- Sponsor's protocol ID
- 114866
- Status last verified
- May 2013
- First submitted
- 23 Jun 2011
- Last updated
- 13 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Prevalence, and Symptom Burden Associated With Advanced Renal Cell Carcinoma in Commercially Insured Population (Pharmetrics)
- ClinicalTrials.gov ID
- NCT01381601
- Acronym / sponsor ID
- 114866
- Conditions
- Carcinoma, Renal Cell
- Keywords
- retrospective database analysis, economic burden
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Information on the prevalence of advanced/metastatic renal cell carcinoma and its symptom burden is limited in commercially insured adult patients. Additionally, limited information exists on economic burden of adverse events associated with treatments for advanced/metastatic renal cell carcinoma. An objective of the current study is to estimate the incidence, prevalence, and symptom burden associated with advanced/metastatic RCC in a US "real-world" setting. Another objective is to quantify the economic burden of severe adverse events with agents used in management of first line advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib). This study will employ a retrospective cohort design. Analyses of health insurance claims data from a large commercially insured population will be employed in the current study. Study subjects will consist of all persons, aged ≥18 years, with evidence of advanced RCC between January 1, 2000 and December 31, 2009; these persons will be identified based in part on case-ascertainment algorithms. Analyses will be directed at estimating annual rates of incidence and prevalence of advanced/metastatic RCC, as well as symptom burden and costs of common severe adverse events associated with treatments used in management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe adverse event claims in subjects with metastatic RCC | – | Drug: Targeted agents indicated in management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib)Presence or absence of common severe treatment related adverse events (based on existence of claims) in patients with metastatic RCC. Common severe adverse event defined as Grade 3 or higher with >=5% frequency of occurence as reported in product label. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Study subjects will be selected from a source population consisting of all persons in the PharMetrics database with one or more days of eligibility for comprehensive health benefits between January 1, 2000 and December 31, 2009.
Key inclusion criteria (2 listed)
- two or more medical encounters with a diagnosis of kidney cancer (ICD-9-CM 189.0) or malignant neoplasm of the renal pelvis (189.1), and
- two or more medical encounters with a diagnosis of distant secondary malignant neoplasm (ICD-9-CM 197.XX-199.0, excluding 198.0 [kidney metastasis]) on different days <120 days apart (the date of the earliest such encounter will be designated the "index date").
Key exclusion criteria (3 listed)
- evidence of receipt of chemotherapeutic agents indicated or used in the treatment of advanced TCC, or
- evidence of cystoscopy, biopsy of the bladder, or radical cystectomy
- evidence of any other primary cancer
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 |
|---|---|---|
| Targeted agents indicated in management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib)Also: VOTRIENT™ (pazopanib), SUTENT® (sunitinib malate), AVASTIN® (bevacizumab), NEXAVAR® (sorafenib)Metastatic RCC patients on either sunitinib or sorafenib or bevacizumab or pazopanib (identified based on claims) will be evaluated for presence or absence of common severe adverse events. These common severe adverse events will be identified from agent's product labels. | Drug | Severe adverse event claims in subjects with metastatic RCC |
Primary outcome
New and existing claims of metastatic renal cell carcinoma across multiple years
Time frame: 2000 - 2009 (up to 10 years)
Identifying new and existing claims (based on claims based case-ascertainment algorithm) of metastatic renal cell carcinoma across multiple years
Cost associated with management of common severe adverse events related to 1st line treatments used in metastatic renal cell carcinoma
Time frame: 2000 - 2009 (up to 10 years)
Quantifying economic burden associated with management of common severe adverse events (defined as grade 3 and above adverse events occurring >= 5% as per product label) related to agents used in 1st line metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib). Adverse events will be identified based on product labels.
1 secondary outcome
Quantify symptom burden associated with metastatic renal cell carcinoma
Time frame: 2000 - 2009 (up to 10 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2013.
Related trials for Carcinoma, Renal Cell
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Renal Cell, run by GlaxoSmithKline.
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 2 inclusion and 3 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 13 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
New and existing claims of metastatic renal cell carcinoma across multiple years (time frame: 2000 - 2009 (up to 10 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2013.