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Tumor Registry of Advanced Renal Cell Carcinoma (RCC-Registry)

This study is currently recruiting participants.
Verified February 2013 by iOMEDICO AG
Sponsor:
Collaborators:
Arbeitskreis Klinische Studien
BayerVital GmbH
Bund der Urologen e.G.
Novartis Pharmaceuticals
Roche Pharma AG
Pfizer
GlaxoSmithKline
Astellas Pharma Europe Ltd.
Information provided by (Responsible Party):
iOMEDICO AG
ClinicalTrials.gov Identifier:
NCT00610012
First received: January 25, 2008
Last updated: February 18, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this registry is to record information of therapy reality of metastatic or locally advanced Renal Cell Carcinoma in Germany. The outcome of this registry will describe the changes of the used therapies within 9 years. It will give conclusions about course of disease and therapy sequences. Based on the data a prognostic score will be developed.


Condition
Renal Cell Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Registry Describing Treatment Reality and Therapy Modality of Patients With Metastatic or Locally Advanced Renal Cell Carcinoma Requiring Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by iOMEDICO AG:

Primary Outcome Measures:
  • Documentation of therapies [ Time Frame: 9 years, 3 years per patient ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Documentation of response rate and adverse reactions; development of a numeric prognostic score [ Time Frame: 9 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: December 2007
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Advanced RCC
Patients with metastatic or locally advanced Renal Cell Carcinoma requiring therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Practitioners specialized in oncology and urology in Germany

Criteria

Inclusion Criteria:

  • Patients with metastatic or locally advanced Renal Cell Carcinoma requiring therapy
  • Start of first palliative therapy within 1 year before enrollment of patient to registry; since enrollment of 1000 Patients: start of first palliative therapy within 4 weeks before enrollment

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610012

Locations
Germany
iOMEDICO Recruiting
Freiburg, Germany
Contact: iOMEDICO AG     +49 761 152420     info@iomedico.com    
Sponsors and Collaborators
iOMEDICO AG
Arbeitskreis Klinische Studien
BayerVital GmbH
Bund der Urologen e.G.
Novartis Pharmaceuticals
Roche Pharma AG
Pfizer
GlaxoSmithKline
Astellas Pharma Europe Ltd.
  More Information

Publications:
Amato RJ, Harris P, Dalton M, Khan M, Alter R, Zhai Q, Brady JR, Jac J, Hauke R, Srinivas S. The Methodist Hospital Research Institute, Houston, TX, United States. A phase II trial of intra-patient dose-escalated sorafenib in patients (pts) with metastatic renal cell cancer (MRCC). ASCO 2007, Abstract 5026

Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT00610012     History of Changes
Other Study ID Numbers: IOM RCC
Study First Received: January 25, 2008
Last Updated: February 18, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by iOMEDICO AG:
Advanced Renal Cell Carcinoma
MRCC
Therapy-reality
Observation
Registry
RCC
ARCC
Germany
Metastatic Renal Cell Carcinoma
Renal Cell Carcinoma
 Renal Cell Cancer
Sorafenib
Sunitinib
Interferon
Interleukin
Temsirolimus
Pazopanib
Cytokines
VEGF

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013