Tumor Registry of Advanced Renal Cell Carcinoma

Renal Cell Carcinoma Clinical Trial

— RCC-Registry  

Official title:

Clinical Registry Describing Treatment Reality and Therapy Modality of Patients With Metastatic or Locally Advanced Renal Cell Carcinoma Requiring Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00610012
• Other study ID #: IOM RCC
• Status: Completed
• Start date: December 2007
• Est. completion date: May 15, 2020

Study information

• Verified date: May 2020
• Source: iOMEDICO AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: May 15, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Locations

Country	Name	City	State
Germany	iOMEDICO	Freiburg

Sponsors (3)

Lead Sponsor	Collaborator
iOMEDICO AG	Arbeitskreis Klinische Studien, Bund der Urologen e.G.

Country where clinical trial is conducted

Germany, 

References & Publications (6)

Goebell PJ, Müller L, Hübner A, Harich HD, Boller E, Koska M, Jänicke M, Marschner N; RCC-Registry Group (Tumour Registry of Advanced Renal Cell Carcinoma). Body mass index as independent predictor of overall survival in patients with advanced renal cell — View Citation

Goebell PJ, Müller L, Hurtz HJ, Koska M, Busies S, Marschner N. A Cross-Sectional Investigation of Fatigue, Mucositis, Hand-Foot Syndrome and Dysgeusia in Advanced Renal Cell Carcinoma Treatment: Final Results From the FAMOUS Study. Clin Genitourin Cancer — View Citation

Goebell PJ, Staehler M, Müller L, Nusch A, Scheffler M, Sauer A, von Verschuer U, Tech S, Kruggel L, Jänicke M, Marschner N; RCC-Registry Group (Tumour Registry of Advanced Renal Cell Carcinoma). Changes in Treatment Reality and Survival of Patients With — View Citation

Marschner N, Müller L, Münch A, Blumenstengel K, Hutzschenreuter U, Busies S. Adverse reactions in mRCC patients documented in routine practice by German office-based oncologists and uro-oncologists. J Oncol Pharm Pract. 2017 Jun;23(4):288-295. doi: 10.11 — View Citation

Marschner N, Staehler M, Müller L, Nusch A, Harde J, Koska M, Jänicke M, Goebell PJ; RCC Registry Group. Survival of Patients With Advanced or Metastatic Renal Cell Carcinoma in Routine Practice Differs From That in Clinical Trials-Analyses From the Germa — View Citation

P J G, A M, L M, H J H, M K, S B, N M. A cross-sectional investigation of fatigue in advanced renal cell carcinoma treatment: results from the FAMOUS study. Urol Oncol. 2014 Apr;32(3):362-70. doi: 10.1016/j.urolonc.2013.09.009. Epub 2013 Dec 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Documentation of therapies		9 years, 3 years per patient
Secondary	Documentation of response rate and adverse reactions; development of a numeric prognostic score		9 years