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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01286662
Other study ID # TriemliH
Secondary ID
Status Completed
Phase N/A
First received January 25, 2011
Last updated January 27, 2011
Start date January 1978
Est. completion date December 2010

Study information

Verified date January 2011
Source Triemli Hospital
Contact n/a
Is FDA regulated No
Health authority Switzerland: Laws and standards
Study type Observational

Clinical Trial 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.


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 BT/RT, all patients showed full or partial remission.


Recruitment information / eligibility

Status Completed
Enrollment 105
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- family with an identical adenomatous polyposis coli (APC-) germ line mutation

Exclusion Criteria:

- negative testing for adenomatous polyposis coli (APC-) germ line mutation

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Triemli Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary mortality 1978-2010 (as long as patients live) No
Secondary incidence of colorectal carcinoma 1978-2010 (entire patient life) No
Secondary Incidence of desmoid tumors 1978-2010 (entire patient life) No
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