Renal Cell CarcinomaRCC-RegistryNCT00610012
Tumor Registry of Advanced Renal Cell Carcinoma
An observational study of Renal Cell Carcinoma, run by iOMEDICO AG at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- How many people
- 1,500 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2007to 15 May 2020
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Practitioners specialized in oncology and urology in Germany
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- 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
- Medical subject headings
- Carcinoma, Renal Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Documentation of therapies
Measured: 9 years, 3 years per patient
Secondary outcomes (1)
Documentation of response rate and adverse reactions; development of a numeric prognostic score
Measured: 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startDec 2007
- Primary completion15 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by iOMEDICO AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arbeitskreis Klinische Studien, Bund der Urologen e.G.
- Responsible party
- Sponsor
- Investigators
- Goebell Peter, MD, Study chair, Waldkrankenhaus St. Marien, Erlangen, GermanyLothar Müller, MD, Study chair, Onkologie Leer - Emden - Papenburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610012
- Sponsor's protocol ID
- IOM RCC
- Acronym
- RCC-Registry
- Status last verified
- May 2020
- First submitted
- 25 Jan 2008
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 24321255Goebell 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.
PubMed 26520429Marschner 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.
PubMed 27720164Goebell 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.
PubMed 30061035Goebell 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.
PubMed 30131294Marschner 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.
PubMed 26908232
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Registry Describing Treatment Reality and Therapy Modality of Patients With Metastatic or Locally Advanced Renal Cell Carcinoma Requiring Therapy
- ClinicalTrials.gov ID
- NCT00610012
- Acronym / sponsor ID
- RCC-Registry / IOM RCC
- Conditions
- Renal Cell Carcinoma
- Keywords
- Advanced Renal Cell Carcinoma, MRCC, Therapy-reality, Observation, Registry, RCC, ARCC, Germany
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Collaborators
- Arbeitskreis Klinische Studien, Bund der Urologen e.G.
- Study start
- Dec 2007 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 7 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Practitioners specialized in oncology and urology in Germany
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Documentation of therapies
Time frame: 9 years, 3 years per patient
1 secondary outcome
Documentation of response rate and adverse reactions; development of a numeric prognostic score
Time frame: 9 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Results publication: PubMed 24321255P 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.
- Results publication: PubMed 26520429Goebell 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.
- Results publication: PubMed 27720164Marschner 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.
- Results publication: PubMed 30061035Goebell 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.
- Results publication: PubMed 30131294Goebell 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.
- Results publication: PubMed 26908232Marschner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Goebell Peter, MD study chair
Waldkrankenhaus St. Marien, Erlangen, Germany
Lothar Müller, MD study chair
Onkologie Leer - Emden - Papenburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by iOMEDICO AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Documentation of therapies (time frame: 9 years, 3 years per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00610012, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.