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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00610012
First Posted: February 7, 2008
Last Update Posted: August 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Arbeitskreis Klinische Studien
Bund der Urologen e.G.
Information provided by (Responsible Party):
iOMEDICO AG
  Purpose
The purpose of this registry is to record information of therapy reality of metastatic or locally advanced Renal Cell Carcinoma by office-based medical oncologists in Germany.

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:


Further study details as provided by iOMEDICO AG:

Primary Outcome Measures:
  • Documentation of therapies [ Time Frame: 9 years, 3 years per patient ]

Secondary Outcome Measures:
  • Documentation of response rate and adverse reactions; development of a numeric prognostic score [ Time Frame: 9 years ]

Enrollment: 1500
Actual Study Start Date: December 2007
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Detailed Description:
The RCC Registry is a prospective, longitudinal, nation wide cohort study that collects data on the treatment reality of patients with mRCC. At inclusion, data in patient characteristics, comorbidities, tumor characteristics, and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. Patients are followed until death or for a maximum of 3 years.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00610012


Locations
Germany
iOMEDICO
Freiburg, Germany
Sponsors and Collaborators
iOMEDICO AG
Arbeitskreis Klinische Studien
Bund der Urologen e.G.
Investigators
Study Chair: Goebell Peter, MD Waldkrankenhaus St. Marien, Erlangen, Germany
Study Chair: Lothar Müller, MD Onkologie Leer - Emden - Papenburg, Germany
  More Information

Publications:
Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT00610012     History of Changes
Other Study ID Numbers: IOM RCC
First Submitted: January 25, 2008
First Posted: February 7, 2008
Last Update Posted: August 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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