CClinicalTrials.gg
CompletedNCT01339962Updated Aug 18, 2014

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 in Renal Cell Carcinoma, sponsored by Pfizer. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-18.

Sponsored by Pfizer · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,073
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Renal Cell Carcinoma

Keywords

  • Metastatic renal cell carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 1,073 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All Danish patients diagnosed with metastatic renal cell carcinoma referred to the involved centers.

Inclusion criteria

Metastatic renal cell carcinoma

Exclusion criteria

Exclusion Criteria:

None

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,073 participants (actual)

Groups and cohorts

  • Non-Interventional Study

    Outcomes Research Study

    Other: Non-interventional

Interventions

  • OtherNon-interventional

    Non-interventional (retrospective chart reviews)

06

What researchers measure

Primary outcomes

  1. Overall survival from initiation of first systemic anticancer therapy

    Time frame: 8 months

  2. Progression free survival from initiation of each systemic anticancer therapy separately

    Time frame: 8 months

  3. Time to treatment failure from initiation of each systemic anticancer therapy separately

    Time frame: 8 months

Secondary outcomes

  1. Prognostic factors at baseline associated with efficacy (PFS) of each systemic anticancer therapy and overall survival

    Time frame: 8 months

  2. Serious Adverse Events: Defined as AEs leading to dose adjustment, treatment interruption/ cessation or death.

    Time frame: 8 months

  3. Predictive factors

    Time frame: 8 months

  4. Co-morbidity assessed by Charlson Comorbidity Index

    Time frame: 8 months

  5. Combined PFS and OS on sequential treatment

    Time frame: 8 months

  6. Assessment of first line immunotherapy´s effect on second line targeted therapy

    Time frame: 8 months

  7. Assessment of prognostic factors and overall survival for patients not receiving systemic therapy

    Time frame: 8 months

07

Study locations

1 site
  • University of Copenhagen Herlev Hospital
    Herlev, 2730, Denmark
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01339962
Lead sponsor
Pfizer
Collaborators
Copenhagen University Hospital at Herlev, Rigshospitalet, Denmark, Aarhus University Hospital, Odense University Hospital, Danish Renal Cancer Study Group
Responsible party
Sponsor
First posted
Apr 21, 2011
Start date
Apr 2011
Primary completion
Apr 2012
Completion
Apr 2012
Last update
Aug 18, 2014

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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