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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00010774 |
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Date of registration:
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08/09/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Prostate Cancer Outcomes – Compare & Reduce Variation in Prostate Cancer Centers certified by the German Cancer Society; subproject MID-EPIC-D
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Scientific title:
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Prostate Cancer Outcomes – Compare & Reduce Variation in Prostate Cancer Centers certified by the German Cancer Society; subproject MID-EPIC-D
- PCO-D |
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Date of first enrolment:
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01/07/2016 |
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Target sample size:
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70000 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00010774 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: other
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Phase:
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Countries of recruitment
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Austria
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Germany
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Luxembourg
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Switzerland
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Contacts
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Name:
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Christoph
Kowalski |
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Address:
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Kuno-Fischer-Str. 8
14059
Berlin
Germany |
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Telephone:
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0049-30-322932947 |
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Email:
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kowalski@krebsgesellschaft.de |
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Affiliation:
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Deutsche Krebsgesellschaft |
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Name:
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Christoph
Kowalski |
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Address:
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Kuno-Fischer-Str. 8
14059
Berlin
Germany |
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Telephone:
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0049-30-322932947 |
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Email:
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kowalski@krebsgesellschaft.de |
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Affiliation:
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Deutsche Krebsgesellschaft |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with localized prostate cancer
Exclusion criteria: insufficient language skills to fill out questionnaire
Age minimum:
None
Age maximum:
None
Gender:
Male
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Health Condition(s) or Problem(s) studied
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C61
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Malignant neoplasm of prostate
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Intervention(s)
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Group 1: Prostate cancer patients are surveyed pre- and posttherapeutically (EPIC-26 and additional items) to identify differences in outcomes across centers. Additional clinical parameters are collected according to study protocol
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Primary Outcome(s)
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1. (relative) survival, 2. disease-free survival, 3. PROs: 3a. incontinence, 3b. irritative/obstructive, 3c. gastrointestinal, 3d. sexuality, 3e. hormonal, and 3f. libido, collected after 6 and 12 months, then annually
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Secondary Outcome(s)
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formative evaluation of data collection method
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Source(s) of Monetary Support
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Movember Foundation
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Ethics review
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Status: Approved
Approval date: 02/06/2016
Contact:
ek@aekb.de
Ethik-Kommission der Ärztekammer Berlin
(+49)30-408062601
ek@aekb.de
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