Clinical trial NCT00610012: Tumor Registry of Advanced Renal Cell Carcinoma
Official title: Clinical Registry Describing Treatment Reality and Therapy Modality of Patients With Metastatic or Locally Advanced Renal Cell Carcinoma Requiring Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Keywords: 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
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
Collaborators: name: Arbeitskreis Klinische Studien
name: Bund der Urologen e.G.
First posted: 2008-02-07
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Practitioners specialized in oncology and urology in Germany

Brief 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.

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 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:

-

Primary outcomes:
measure: Documentation of therapies
timeFrame: 9 years, 3 years per patient
Secondary outcomes:
measure: Documentation of response rate and adverse reactions; development of a numeric prognostic score
timeFrame: 9 years
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: iOMEDICO
Study officials:
affiliation: Waldkrankenhaus St. Marien, Erlangen, Germany
name: Goebell Peter, MD
role: STUDY_CHAIR
affiliation: Onkologie Leer - Emden - Papenburg, Germany
name: Lothar Müller, MD
role: STUDY_CHAIR
References:
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.
citation: Goebell PJ, Muller 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. 2016 Feb;14(1):63-8. doi: 10.1016/j.clgc.2015.09.004. Epub 2015 Sep 25.
citation: Marschner N, Staehler M, Muller L, Nusch A, Harde J, Koska M, Janicke 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 German Clinical RCC Registry. Clin Genitourin Cancer. 2017 Apr;15(2):e209-e215. doi: 10.1016/j.clgc.2016.08.022. Epub 2016 Sep 8.
citation: Goebell PJ, Staehler M, Muller L, Nusch A, Scheffler M, Sauer A, von Verschuer U, Tech S, Kruggel L, Janicke M, Marschner N; RCC-Registry Group (Tumour Registry of Advanced Renal Cell Carcinoma). Changes in Treatment Reality and Survival of Patients With Advanced Clear Cell Renal Cell Carcinoma - Analyses From the German Clinical RCC-Registry. Clin Genitourin Cancer. 2018 Dec;16(6):e1101-e1115. doi: 10.1016/j.clgc.2018.06.006. Epub 2018 Jun 27.
citation: Goebell PJ, Muller L, Hubner A, Harich HD, Boller E, Koska M, Janicke 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 carcinoma at start of systemic treatment-Analyses from the German clinical RCC-Registry. Urol Oncol. 2018 Oct;36(10):470.e1-470.e9. doi: 10.1016/j.urolonc.2018.07.007. Epub 2018 Aug 18.
citation: Marschner N, Muller L, Munch 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: 10.1177/1078155216632379. Epub 2016 Feb 22.