CancerNCT00871520
Prognosis and Survival Estimates in Palliative Therapy
An observational study of Cancer, run by Heinrich-Heine University, Duesseldorf at 3 sites in Germany.
Trial summary
The accuracy of clinical survival estimates is tested in comparison to objective prognostic scores. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- no specific interventions
- How many people
- 612 participants
- Where
- 3 sitesGermany
- Study dates
- Apr 2008to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive unselected cancer patients referred for palliative treatment to one of the participating institutions.
Who may be able to join
- 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
Who cannot join
- therapy with curative intent
- regular clinical follow-up visit without disease progression
- ongoing therapy
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
University Hospital Duesseldorf, Radiation Oncology Dept.
Düsseldorf, North Rhine-Westphalia, 40225
Sana Kliniken Duesseldorf Benrath
Düsseldorf, North Rhine-Westphalia, 40593
Sana Kliniken Duesseldorf Gerresheim, MVZ Onkologie
Düsseldorf, North Rhine-Westphalia, 40625
About this study
Official title: Prognosis in Palliative Therapy - a Prospective Study on Survival Prognostication in Advanced Stage Cancer Patients
The accuracy of clinical survival estimates is tested in comparison to objective prognostic scores.
Read the 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.
- Conditions
- Cancer
- Being tested
- no specific interventions
- Keywords
- Palliative Care, Predictive Value of Tests, Prospective Studies, Survival Analysis, Survival prediction
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no specific interventionsOther
There are no specific interventions in this observational study
| Study group | Role | What they receive |
|---|---|---|
| Palliative Therapy | Patients referred to the oncology / radiation oncology departments for palliative therapy. Receives: Other: no specific interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startApr 2008
- Primary completionDec 2011
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 612 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan Gripp, Dr., Principal investigator, Universtity Hospital Duesseldorf, Radiation Oncology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871520
- Sponsor's protocol ID
- Pro-08
- Status last verified
- Aug 2016
- First submitted
- 27 Mar 2009
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17664480
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis in Palliative Therapy - a Prospective Study on Survival Prognostication in Advanced Stage Cancer Patients
- ClinicalTrials.gov ID
- NCT00871520
- Acronym / sponsor ID
- Pro-08
- Conditions
- Cancer
- Keywords
- Palliative Care, Predictive Value of Tests, Prospective Studies, Survival Analysis, Survival prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 612 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 30 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palliative Therapy | – | Other: no specific interventionsPatients referred to the oncology / radiation oncology departments for palliative therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive unselected cancer patients referred for palliative treatment to one of the participating institutions.
Key inclusion criteria (6 listed)
- oncologic disease confirmed
- incurable locally advanced or metastatic disease
- palliative treatment intended
- age > 18
- able to understand the study protocol
Key exclusion criteria (3 listed)
- therapy with curative intent
- regular clinical follow-up visit without disease progression
- ongoing therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no specific interventionsThere are no specific interventions in this observational study | Other | Palliative Therapy |
Primary outcome
Survival
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
- Background: PubMed 17664480Gripp 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Gripp, Dr. principal investigator
Universtity Hospital Duesseldorf, Radiation Oncology Department
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Heinrich-Heine University, Duesseldorf at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00871520, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2016.