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NCT00871520 Clinical Trial

Prognosis and Survival Estimates in Palliative Therapy

Cancer Clinical Trial

Official title:
Prognosis in Palliative Therapy - a Prospective Study on Survival Prognostication in Advanced Stage Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00871520
Other study ID # Pro-08
Secondary ID
Status Completed
Phase N/A
First received March 27, 2009
Last updated August 22, 2016
Start date April 2008
Est. completion date August 2016

Study information
Verified date August 2016
Source Heinrich-Heine University, Duesseldorf
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 612
Est. completion date August 2016
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• no specific interventions
There are no specific interventions in this observational study

Locations
Country Name City State
Germany Sana Kliniken Duesseldorf Benrath Duesseldorf NRW
Germany Sana Kliniken Duesseldorf Gerresheim, MVZ Onkologie Duesseldorf NRW
Germany University Hospital Duesseldorf, Radiation Oncology Dept. Duesseldorf NRW

Sponsors (1)
Lead Sponsor Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Gripp S, Moeller S, Bölke E, Schmitt G, Matuschek C, Asgari S, Asgharzadeh F, Roth S, Budach W, Franz M, Willers R. Survival prediction in terminally ill cancer patients by clinical estimates, laboratory tests, and self-rated anxiety and depression. J Clin Oncol. 2007 Aug 1;25(22):3313-20. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Survival 6 months No
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