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Prognosis and Survival Estimates in Palliative Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00871520
First Posted: March 30, 2009
Last Update Posted: August 23, 2016
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.
Information provided by (Responsible Party):
Heinrich-Heine University, Duesseldorf
  Purpose
The accuracy of clinical survival estimates is tested in comparison to objective prognostic scores.

Condition Intervention
Cancer Other: no specific interventions

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognosis in Palliative Therapy - a Prospective Study on Survival Prognostication in Advanced Stage Cancer Patients

Resource links provided by NLM:


Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • Survival [ Time Frame: 6 months ]

Enrollment: 612
Study Start Date: April 2008
Study Completion Date: August 2016
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Palliative Therapy
Patients referred to the oncology / radiation oncology departments for palliative therapy.
Other: no specific interventions
There are no specific interventions in this observational study

Detailed Description:
  • At presentation a clinical survival estimate is obtained in each patient.
  • Survival is also estimated using published prognostic scores in palliative care.
  • Prognostic scores based on blood samples, general symptoms, complaints, and performance status are calculated and validated, respectively
  • Each patient completes questionnaires on psychological distress
  • Survival estimates are limited to 6 months.
  • Each patient is followed for at least 6 months.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive unselected cancer patients referred for palliative treatment to one of the participating institutions.
Criteria

Inclusion Criteria:

  • oncologic disease confirmed
  • incurable locally advanced or metastatic disease
  • palliative treatment intended
  • age > 18
  • able to understand the study protocol
  • able to complete the forms with assistance if necessary

Exclusion Criteria:

  • therapy with curative intent
  • regular clinical follow-up visit without disease progression
  • ongoing therapy
  Contacts and Locations
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): NCT00871520


Locations
Germany
University Hospital Duesseldorf, Radiation Oncology Dept.
Duesseldorf, NRW, Germany, 40225
Sana Kliniken Duesseldorf Benrath
Duesseldorf, NRW, Germany, 40593
Sana Kliniken Duesseldorf Gerresheim, MVZ Onkologie
Duesseldorf, NRW, Germany, 40625
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
Principal Investigator: Stephan Gripp, Dr. Universtity Hospital Duesseldorf, Radiation Oncology Department
  More Information

Publications:
Responsible Party: Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT00871520     History of Changes
Other Study ID Numbers: Pro-08
First Submitted: March 27, 2009
First Posted: March 30, 2009
Last Update Posted: August 23, 2016
Last Verified: August 2016

Keywords provided by Heinrich-Heine University, Duesseldorf:
Palliative Care
Predictive Value of Tests
Prospective Studies
Survival Analysis
Survival prediction