NCT00610012

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 7, 2008

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

12.5 years

First QC Date

January 25, 2008

Last Update Submit

May 26, 2020

Conditions

Renal Cell Carcinoma

Keywords

Advanced Renal Cell CarcinomaMRCCTherapy-realityObservationRegistryRCCARCCGermanyMetastatic Renal Cell CarcinomaRenal Cell CarcinomaRenal Cell CancerSorafenibSunitinibInterferonInterleukinTemsirolimusPazopanibCytokinesVEGF

Outcome Measures

Primary Outcomes (1)

  • Documentation of therapies

    9 years, 3 years per patient

Secondary Outcomes (1)

  • Documentation of response rate and adverse reactions; development of a numeric prognostic score

    9 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Practitioners specialized in oncology and urology in Germany

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

iOMEDICO

Freiburg im Breisgau, Germany

Location

Related Publications (6)

  • 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.

    PMID: 24321255RESULT

  • 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.

    PMID: 26520429RESULT

  • 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.

    PMID: 27720164RESULT

  • 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.

    PMID: 30061035RESULT

  • 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.

    PMID: 30131294RESULT

  • 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.

    PMID: 26908232RESULT

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Goebell Peter, MD

    Waldkrankenhaus St. Marien, Erlangen, Germany

    STUDY CHAIR

  • Lothar Müller, MD

    Onkologie Leer - Emden - Papenburg, Germany

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2008

First Posted

February 7, 2008

Study Start

December 1, 2007

Primary Completion

May 15, 2020

Study Completion

May 15, 2020

Last Updated

May 27, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)