Renal Cell CarcinomaNCT01339962
Retrospective Analysis Of Progression Free Survival And Overall Survival In A National Cohort Of Patients With Metastatic Renal Cell Carcinoma Treated In Denmark From 2006-2010. DARENCA Study 2.
An observational study of Renal Cell Carcinoma, run by Pfizer at 1 site in Denmark.
Trial summary
Non-interventional study. Data obtained by patient chart reviews. Retrospective analysis of progression free survival, time to treatment failure and overall survival in a national cohort of patients with metastatic renal cell carcinoma treated in Denmark from 2006-2010 Safety, prognostic factors, predictive factors… 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?
- Non-interventional
- How many people
- 1,073 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2011to Apr 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All Danish patients diagnosed with metastatic renal cell carcinoma referred to the involved centers.
Who may be able to join
- Metastatic renal cell carcinoma
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Non-interventional study. Data obtained by patient chart reviews.
Retrospective analysis of progression free survival, time to treatment failure and overall survival in a national cohort of patients with metastatic renal cell carcinoma treated in Denmark from 2006-2010 Safety, prognostic factors, predictive factors and co-morbidity assessed by Charlson Comorbidity Index.
The following drugs will be evaluated: Sunitinib, Sorafenib, Temsirolimus, Everolimus, Aldesleukin, Interferon-alfa-2b.
Read the detailed description
No sampling. All eligible patients will be included.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Non-interventional
- Keywords
- Metastatic renal cell carcinoma
- 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.
Non-interventionalOther
Non-interventional (retrospective chart reviews)
| Study group | Role | What they receive |
|---|---|---|
| Non-Interventional Study | Outcomes Research Study Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival from initiation of first systemic anticancer therapy
Measured: 8 months
Progression free survival from initiation of each systemic anticancer therapy separately
Measured: 8 months
Time to treatment failure from initiation of each systemic anticancer therapy separately
Measured: 8 months
Secondary outcomes (7)
Prognostic factors at baseline associated with efficacy (PFS) of each systemic anticancer therapy and overall survival
Measured: 8 months
Serious Adverse Events: Defined as AEs leading to dose adjustment, treatment interruption/ cessation or death.
Measured: 8 months
Predictive factors
Measured: 8 months
Co-morbidity assessed by Charlson Comorbidity Index
Measured: 8 months
Combined PFS and OS on sequential treatment
Measured: 8 months
Assessment of first line immunotherapy´s effect on second line targeted therapy
Measured: 8 months
Assessment of prognostic factors and overall survival for patients not receiving systemic therapy
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1,073 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Copenhagen University Hospital at Herlev, Copenhagen University Hospital, Rigshospitalet, Aarhus University Hospital, Odense University Hospital, Danish Renal Cancer Study Group
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339962
- Sponsor's protocol ID
- A6181203
- Other IDs
- DARENCA STUDY 2
- Status last verified
- Aug 2014
- First submitted
- 15 Apr 2011
- Last updated
- 18 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis Of Progression Free Survival And Overall Survival In A National Cohort Of Patients With Metastatic Renal Cell Carcinoma Treated In Denmark From 2006-2010. DARENCA Study 2.
- ClinicalTrials.gov ID
- NCT01339962
- Acronym / sponsor ID
- A6181203
- Conditions
- Renal Cell Carcinoma
- Keywords
- Metastatic renal cell carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,073 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Copenhagen University Hospital at Herlev, Copenhagen University Hospital, Rigshospitalet, Aarhus University Hospital, Odense University Hospital, Danish Renal Cancer Study Group
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 21 Apr 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.
Non-interventional study. Data obtained by patient chart reviews.
Retrospective analysis of progression free survival, time to treatment failure and overall survival in a national cohort of patients with metastatic renal cell carcinoma treated in Denmark from 2006-2010 Safety, prognostic factors, predictive factors and co-morbidity assessed by Charlson Comorbidity Index.
The following drugs will be evaluated: Sunitinib, Sorafenib, Temsirolimus, Everolimus, Aldesleukin, Interferon-alfa-2b.
Detailed description
No sampling. All eligible patients will be included.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-Interventional Study | – | Other: Non-interventionalOutcomes Research Study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Danish patients diagnosed with metastatic renal cell carcinoma referred to the involved centers.
Key inclusion criteria (1 listed)
- Metastatic renal cell carcinoma
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 |
|---|---|---|
| Non-interventionalNon-interventional (retrospective chart reviews) | Other | Non-Interventional Study |
Primary outcome
Overall survival from initiation of first systemic anticancer therapy
Time frame: 8 months
Progression free survival from initiation of each systemic anticancer therapy separately
Time frame: 8 months
Time to treatment failure from initiation of each systemic anticancer therapy separately
Time frame: 8 months
7 secondary outcomes
Prognostic factors at baseline associated with efficacy (PFS) of each systemic anticancer therapy and overall survival
Time frame: 8 months
Serious Adverse Events: Defined as AEs leading to dose adjustment, treatment interruption/ cessation or death.
Time frame: 8 months
Predictive factors
Time frame: 8 months
Co-morbidity assessed by Charlson Comorbidity Index
Time frame: 8 months
Combined PFS and OS on sequential treatment
Time frame: 8 months
Assessment of first line immunotherapy´s effect on second line targeted therapy
Time frame: 8 months
Assessment of prognostic factors and overall survival for patients not receiving systemic therapy
Time frame: 8 months
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 18 Aug 2014.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Renal Cell Carcinoma
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.
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 Denmark.
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 1 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 18 Aug 2014. 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 Denmark. 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?
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?
Overall survival from initiation of first systemic anticancer therapy (time frame: 8 months). The study lists 3 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 18 Aug 2014.