- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00610012
Tumor Registry of Advanced Renal Cell Carcinoma (RCC-Registry)
May 26, 2020 updated by: iOMEDICO AG
Clinical Registry Describing Treatment Reality and Therapy Modality of Patients With Metastatic or Locally Advanced Renal Cell Carcinoma Requiring Therapy
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
1500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Freiburg, Germany
- iOMEDICO
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Practitioners specialized in oncology and urology in Germany
Description
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:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Documentation of therapies
Time Frame: 9 years, 3 years per patient
|
9 years, 3 years per patient
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Documentation of response rate and adverse reactions; development of a numeric prognostic score
Time Frame: 9 years
|
9 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Goebell Peter, MD, Waldkrankenhaus St. Marien, Erlangen, Germany
- Study Chair: Lothar Müller, MD, Onkologie Leer - Emden - Papenburg, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2007
Primary Completion (Actual)
May 15, 2020
Study Completion (Actual)
May 15, 2020
Study Registration Dates
First Submitted
January 25, 2008
First Submitted That Met QC Criteria
February 6, 2008
First Posted (Estimate)
February 7, 2008
Study Record Updates
Last Update Posted (Actual)
May 27, 2020
Last Update Submitted That Met QC Criteria
May 26, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IOM RCC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Renal Cell Carcinoma
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Renal Cell Carcinoma | Metastatic Clear Cell Renal Cell Carcinoma | Advanced Clear Cell Renal Cell Carcinoma | Stage III Renal Cell Cancer AJCC v8 | Stage IV Renal Cell Cancer AJCC v8 | Metastatic Sarcomatoid Renal Cell Carcinoma | Advanced Renal Cell Carcinoma | Unresectable Renal Cell... and other conditionsUnited States
-
Australian and New Zealand Urogenital and Prostate...RecruitingRenal Cell Carcinoma | Sarcomatoid Renal Cell Carcinoma | Papillary Renal Cell Carcinoma Type 1 | Papillary Renal Cell Carcinoma Type 2 | Chromophobe Renal Cell Carcinoma | Xp11.2 Translocation-Related Renal Cell CarcinomaAustralia
-
National Cancer Institute (NCI)CompletedClear Cell Renal Cell Carcinoma | Recurrent Renal Cell Carcinoma | Sarcomatoid Renal Cell Carcinoma | Stage IV Renal Cell Cancer | Chromophobe Renal Cell Carcinoma | Papillary Renal Cell CarcinomaUnited States
-
National Cancer Institute (NCI)CompletedClear Cell Renal Cell Carcinoma | Recurrent Renal Cell Carcinoma | Stage IV Renal Cell Cancer | Type 1 Papillary Renal Cell Carcinoma | Type 2 Papillary Renal Cell CarcinomaUnited States, Taiwan, Australia
-
Bradley A. McGregor, MDBristol-Myers Squibb; ExelixisRecruitingRenal Cell Carcinoma | Chromophobe Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | Unclassified Renal Cell Carcinoma | Collecting Duct Renal Cell Carcinoma | Translocation Renal Cell Carcinoma | Unresectable Advanced Renal Cell Carcinoma | Metastatic Ncc Renal Cell CarcinomaUnited States
-
Jonsson Comprehensive Cancer CenterBeiGene; Driven To CureWithdrawnMetastatic Renal Cell Carcinoma | Stage IV Renal Cell Cancer AJCC v8 | Papillary Renal Cell Carcinoma | Collecting Duct Carcinoma | Unresectable Renal Cell Carcinoma | Hereditary Leiomyomatosis and Renal Cell Carcinoma | Clear Cell Papillary Renal Neoplasm | Hereditary Papillary Renal Cell Carcinoma and other conditionsUnited States
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingChromophobe Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | Unclassified Renal Cell Carcinoma | Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma | Fumarate Hydratase Deficient Renal Cell Carcinoma | Succinate Dehydrogenase Deficient Renal Cell Carcinoma | Collecting Duct Renal...United States
-
Australian and New Zealand Urogenital and Prostate...Bristol-Myers SquibbActive, not recruitingRenal Cell Carcinoma | Sarcomatoid Renal Cell Carcinoma | Papillary Renal Cell Carcinoma Type 1 | Papillary Renal Cell Carcinoma Type 2 | Chromophobe Renal Cell Carcinoma | Xp11 Translocation CarcinomaAustralia
-
National Cancer Institute (NCI)Canadian Cancer Trials GroupActive, not recruitingUnresectable Renal Cell Carcinoma | Stage III Renal Cell Cancer AJCC v7 | Stage IV Renal Cell Cancer AJCC v7 | Type 1 Papillary Renal Cell Carcinoma | Type 2 Papillary Renal Cell Carcinoma | Metastatic Papillary Renal Cell Carcinoma | Locally Advanced Papillary Renal Cell CarcinomaUnited States, Canada
-
Peloton Therapeutics, Inc.Active, not recruitingKidney Cancer | Renal Cell Carcinoma | Renal Cancer | Renal Cell Carcinoma (RCC) | Renal Cell Cancer Metastatic | Kidney | Clear Cell Renal Cell Carcinoma (ccRCC) | Renal Cell Carcinoma Recurrent | Renal Cell Cancer, RecurrentUnited States