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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02303353
Recruitment Status : Unknown
Verified February 2017 by SPGO Research Mannheim GmbH.
Recruitment status was:  Recruiting
First Posted : November 27, 2014
Last Update Posted : February 24, 2017
Sponsor:
Collaborator:
AKP Freiburg GmbH
Information provided by (Responsible Party):
SPGO Research Mannheim GmbH

Brief 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.

Condition or disease
Carcinoma

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Data Base Project for Acquisition of Cancer Patient Data in Practices and Ambulant Therapy
Study Start Date : October 2013
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018


Group/Cohort
Cancer patients
Patients suffering from a carcinoma (either breast, ovarian, lung, colon, stomach, pancreas, rectum or plasmacytoma)



Primary Outcome Measures :
  1. Anti-cancer treatments (Course of the disease and type of applied anti-cancer therapies. Assessment of guidelines' implementation) [ Time Frame: From date of ICF until date of cure/death/ICF withdrawal, up to 60 months ]
    Course of the disease and type of applied anti-cancer therapies. Assessment of guidelines' implementation


Secondary Outcome Measures :
  1. Adverse reactions and their treatment (Number and type of adverse reactions and applied counter measures / therapies) [ Time Frame: From date of ICF until date of cure/death/ICF withdrawal, up to 60 months ]
    Number and type of adverse reactions and applied counter measures / therapies



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suffering from carcinoma which are treated in practices (ambulant therapy)
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303353


Contacts
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Contact: Hilde Huber +49 761 479 400 info@akp-freiburg.de

Locations
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Germany
Practice Recruiting
Mannheim, Germany, 68165
Sponsors and Collaborators
SPGO Research Mannheim GmbH
AKP Freiburg GmbH
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Responsible Party: SPGO Research Mannheim GmbH
ClinicalTrials.gov Identifier: NCT02303353    
Other Study ID Numbers: REGONKO-01
First Posted: November 27, 2014    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017
Keywords provided by SPGO Research Mannheim GmbH:
Breast cancer
Ovarian cancer
Lung cancer
Colon cancer
Gastric cancer
Pancreatic cancer
Rectum cancer
Plasmacytoma