Prognosis and Survival Estimates in Palliative Therapy | NCT00871520

Studies
Prognosis and Survival Estimates in Palliative Therapy

NCT00871520

Sponsor

Heinrich-Heine University, Duesseldorf

Status

Completed

Last Update Posted

Aug 23, 2016Estimated

Enrollment

612Actual

Phase

Not provided

Conditions

Cancer

Interventions

no specific interventions

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Dec 2011Actual

Completion Date

Aug 2016Actual

First Submitted Date

Mar 27, 2009

First Submission Date that Met QC Criteria

Mar 27, 2009

First Posted Date

Mar 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2016

Last Update Posted Date

Aug 23, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

612Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Palliative Therapy		Patients referred to the oncology / radiation oncology departments for palliative therapy.	Other: no specific interventions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no specific interventions	Other	There are no specific interventions in this observational study	Palliative Therapy

Measure	Description	Time Frame
Survival		6 months

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Consecutive unselected cancer patients referred for palliative treatment to one of the participating institutions.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephan Gripp, Dr.	Universtity Hospital Duesseldorf, Radiation Oncology Department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Duesseldorf, Radiation Oncology Dept.		Düsseldorf	North Rhine-Westphalia	40225	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17664480	Background	Gripp S, Moeller S, Bolke 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. doi: 10.1200/JCO.2006.10.5411.