Ignite Creation Date:
2024-05-05 @ 11:14 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01286662
Status:
COMPLETED
Last Update Posted:
2011-01-31
First Post:
2011-01-25
Brief Title:
A Cohort Study of Patients Treated With Brachytherapy for Selected Desmoid Patients in Gardner Syndrome
Sponsor:
Triemli Hospital
Organization:
Triemli Hospital
Study Overview
Official Title:
In Modern Era Recurrent Desmoids Determine Outcome in Patients With Gardner Syndrome A Cohort Study of Three Generations of an Adenomatous Polyposis Coli APC- Mutation-Positive Family Across 30 Years
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the long-term outcome in a cohort of Gardner-Syndrome patients receiving prophylaxis and treatment for intestinal and non-intestinal tumors
Detailed Description:
Since 1978 we have been following a family of 105 descendants with Gardner Syndrome GS Mutation carriers were screened by endoscopy and colorectal resection was performed upon pending malignancy Resectable desmoid tumors were excised whereas large tumors of the abdominal wall were treated by a combination of brachytherapy BT and radiotherapy RT Outcome was analyzed with respect to length of tumor-free survival and morbidity from surgery or radiotherapy Results 37 of 105 family members have GS Preventive colorectal resections were performed in 16 patients 15 with one death due to subsequent gastric cancer In 4 patients who denied screening endoscopy invasive tumors of the colon 3 patients and stomach one patient each developed Of 33 desmoid tumors 10 30 were located in the mesentery 17 52 in the abdominal wall and 6 18 in extra-abdominal sites Excision of 12 desmoids was performed in 8 patients 36 and 4 were treated by a combination of BT and RT Following BTRT all patients showed full or partial remission
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None