Data Base Project for Acquisition of Cancer Patient Data in Practices and Ambulant Therapy

Carcinoma Clinical Trial

Official title:

Data Base Project for Acquisition of Cancer Patient Data in Practices and Ambulant Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02303353
• Other study ID #: REGONKO-01
• Status: Recruiting
• Phase: N/A
• First received: November 3, 2014
• Last updated: February 23, 2017
• Start date: October 2013
• Est. completion date: September 2018

Study information

• Verified date: February 2017
• Source: SPGO Research Mannheim GmbH
• Contact: Hilde Huber
• Phone: +49 761 479 400
• Email: info[@]akp-freiburg.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this registry is to evaluate the situation regarding ambulant therapy of cancer patients in different practices in Germany. It should provide insight into the implementation of schemes for cancer therapy predefined in the guidelines, the treatment of diverse adverse reactions and the counter measures taken. Thereby, potential differences in treatment and with that differences in quality amongst individual practices might be identified. The medium to long term aim is to contribute to positively influence the quality of medical care of cancer patients in Germany.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years and older

• Tumor disease (carcinoma of either breast, ovary, lung, colon, stomach, pancreas, rectum or plasmacytoma)

• Written informed consent

Exclusion Criteria: none

Related Conditions & MeSH terms

• Carcinoma

Locations

Country	Name	City	State
Germany	Practice	Mannheim

Sponsors (2)

Lead Sponsor	Collaborator
SPGO Research Mannheim GmbH	AKP Freiburg GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-cancer treatments (Course of the disease and type of applied anti-cancer therapies. Assessment of guidelines' implementation)	Course of the disease and type of applied anti-cancer therapies. Assessment of guidelines' implementation	From date of ICF until date of cure/death/ICF withdrawal, up to 60 months
Secondary	Adverse reactions and their treatment (Number and type of adverse reactions and applied counter measures / therapies)	Number and type of adverse reactions and applied counter measures / therapies	From date of ICF until date of cure/death/ICF withdrawal, up to 60 months