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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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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN17448795 |
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Date of registration:
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27/09/2004 |
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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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Hereditary non-polyposis colorectal carcinoma (HNPCC) - a prospective randomized trial for the comparison of prophylactic or extended surgery versus oncological resection in colon or rectum carcinoma
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Scientific title:
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Date of first enrolment:
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01/01/2002 |
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Target sample size:
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0 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN17448795 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Gabriela
Möslein |
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Address:
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Klink für Allgemeine und Viszeralchirurgie
Universitätsklinikum Düsseldorf
40225
Düsseldorf
Germany |
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Telephone:
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+49 (0)211/81-16397 |
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Email:
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moeslein@uni-duesseldorf.de |
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Affiliation:
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Colorectal carcinoma fulfilling the Amsterdam-criteria for HNPCC or
2. Colorectal carcinoma in patients with known pathogenic mismatch repair gene mutation or
3. Colorectal carcinoma at the age of 50 or less and detection of microsatellite instability in a tumor biopsy and
4. Age between 18 and 65 years
5. Operability for subtotal colectomy/(restorative) proctocolectomy as estimated by the surgeon
6. Exclusion of metastases, local resection of the complete tumor likely to be possible
7. Elective tumorsurgical operation
8. Willingness of the patient to participate in surveillance required by the trial
9. Informed consent
Exclusion criteria: Not provided at time of registration
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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HNPCC-associated colorectal carcinoma
Cancer
Colorectal
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Intervention(s)
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Subtotal colectomy vs. oncologic resection (restorative proctocolectomy vs rectum resection/extirpation)
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Primary Outcome(s)
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Not provided at time of registration
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Secondary Outcome(s)
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Not provided at time of registration
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Secondary ID(s)
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70-2993 Oh 1
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Source(s) of Monetary Support
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Deutsche Krebshilfe e. V. (70-2993 Oh 1)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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