Tumor Registry of Advanced Renal Cell Carcinoma | NCT00610012

Studies
Tumor Registry of Advanced Renal Cell Carcinoma

NCT00610012

Sponsor

iOMEDICO AG

Status

Completed

Last Update Posted

May 27, 2020Actual

Enrollment

1,500Actual

Phase

Not provided

Conditions

Renal Cell Carcinoma

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007Actual

Primary Completion Date

May 15, 2020Actual

Completion Date

May 15, 2020Actual

First Submitted Date

Jan 25, 2008

First Submission Date that Met QC Criteria

Feb 6, 2008

First Posted Date

Feb 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2020

Last Update Posted Date

May 27, 2020Actual

Name	Class
Arbeitskreis Klinische Studien	OTHER
Bund der Urologen e.G.	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Documentation of therapies		9 years, 3 years per patient

Secondary Outcomes

Measure	Description	Time Frame
Documentation of response rate and adverse reactions; development of a numeric prognostic score		9 years

Other Outcomes

Not provided

Eligibility Module

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:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Practitioners specialized in oncology and urology in Germany

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Goebell Peter, MD	Waldkrankenhaus St. Marien, Erlangen, Germany	Study Chair
Lothar Müller, MD	Onkologie Leer - Emden - Papenburg, Germany	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
iOMEDICO		Freiburg im Breisgau			Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24321255	Result	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.
26520429	Result	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.

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type