Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT00871520
Status:
COMPLETED
Last Update Posted:
2016-08-23
First Post:
2009-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prognosis and Survival Estimates in Palliative Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 612}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-22', 'studyFirstSubmitDate': '2009-03-27', 'studyFirstSubmitQcDate': '2009-03-27', 'lastUpdatePostDateStruct': {'date': '2016-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Palliative Care', 'Predictive Value of Tests', 'Prospective Studies', 'Survival Analysis', 'Survival prediction'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '17664480', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The accuracy of clinical survival estimates is tested in comparison to objective prognostic scores.', 'detailedDescription': '* At presentation a clinical survival estimate is obtained in each patient.\n* Survival is also estimated using published prognostic scores in palliative care.\n* Prognostic scores based on blood samples, general symptoms, complaints, and performance status are calculated and validated, respectively\n* Each patient completes questionnaires on psychological distress\n* Survival estimates are limited to 6 months.\n* Each patient is followed for at least 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive unselected cancer patients referred for palliative treatment to one of the participating institutions.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* oncologic disease confirmed\n* incurable locally advanced or metastatic disease\n* palliative treatment intended\n* age \\> 18\n* able to understand the study protocol\n* able to complete the forms with assistance if necessary\n\nExclusion Criteria:\n\n* therapy with curative intent\n* regular clinical follow-up visit without disease progression\n* ongoing therapy'}, 'identificationModule': {'nctId': 'NCT00871520', 'briefTitle': 'Prognosis and Survival Estimates in Palliative Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Prognosis in Palliative Therapy - a Prospective Study on Survival Prognostication in Advanced Stage Cancer Patients', 'orgStudyIdInfo': {'id': 'Pro-08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Palliative Therapy', 'description': 'Patients referred to the oncology / radiation oncology departments for palliative therapy.', 'interventionNames': ['Other: no specific interventions']}], 'interventions': [{'name': 'no specific interventions', 'type': 'OTHER', 'description': 'There are no specific interventions in this observational study', 'armGroupLabels': ['Palliative Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'University Hospital Duesseldorf, Radiation Oncology Dept.', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '40593', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Sana Kliniken Duesseldorf Benrath', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '40625', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Sana Kliniken Duesseldorf Gerresheim, MVZ Onkologie', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Stephan Gripp, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universtity Hospital Duesseldorf, Radiation Oncology Department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}