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
| ISRCTN | ISRCTN17448795 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17448795 |
| Secondary identifying numbers | 70-2993 Oh 1 |
- Submission date
- 09/06/2004
- Registration date
- 27/09/2004
- Last edited
- 17/12/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Gabriela Möslein
Scientific
Scientific
Klink für Allgemeine und Viszeralchirurgie
Universitätsklinikum Düsseldorf
Düsseldorf
40225
Germany
| Phone | +49 (0)211/81-16397 |
|---|---|
| moeslein@uni-duesseldorf.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | HNPCC-associated colorectal carcinoma |
| Intervention | Subtotal colectomy vs. oncologic resection (restorative proctocolectomy vs rectum resection/extirpation) |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2002 |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- Germany
Study participating centre
Klink für Allgemeine und Viszeralchirurgie
Düsseldorf
40225
Germany
40225
Germany
Sponsor information
Deutsche Krebshilfe e. V. - German Cancer Aid (Germany)
Charity
Charity
Thomas-Mann-Strasse 40
Bonn
53004
Germany
| Phone | +49 (0)228/72990-0 |
|---|---|
| deutsche@krebshilfe.de | |
| Website | http://www.krebshilfe.de/startseite-dkh.html |
"ROR" |
https://ror.org/01wxdd722 |
Funders
Funder type
Charity
Deutsche Krebshilfe e. V. (70-2993 Oh 1)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
