Prognosis and Survival Estimates in Palliative Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT00871520
First received: March 27, 2009
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

The accuracy of clinical survival estimates is tested in comparison to objective prognostic scores.


Condition Intervention
Cancer
Other: palliative standard therapy if indicated

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: April 2008
Estimated Study Completion Date: December 2014
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: palliative standard therapy if indicated
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871520

Locations
Germany
University Hospital Duesseldorf, Radiation Oncology Dept.
Duesseldorf, NRW, Germany, 40225
Sana Kliniken Duesseldorf Gerresheim, MVZ Onkologie
Duesseldorf, NRW, Germany, 40625
Sana Kliniken Duesseldorf Benrath
Duesseldorf, NRW, Germany, 40593
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
Study First Received: March 27, 2009
Last Updated: June 13, 2013
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on August 28, 2014