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A Cohort Study of Patients Treated With Brachytherapy for Selected Desmoid Patients in Gardner Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01286662
First Posted: January 31, 2011
Last Update Posted: January 31, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Triemli Hospital
January 25, 2011
January 31, 2011
January 31, 2011
January 1978
December 2010   (Final data collection date for primary outcome measure)
mortality [ Time Frame: 1978-2010 (as long as patients live) ]
Same as current
No Changes Posted
  • incidence of colorectal carcinoma [ Time Frame: 1978-2010 (entire patient life) ]
  • Incidence of desmoid tumors [ Time Frame: 1978-2010 (entire patient life) ]
Same as current
Not Provided
Not Provided
 
A Cohort Study of Patients Treated With Brachytherapy for Selected Desmoid Patients in Gardner Syndrome
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
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
Since 1978, we have been following a family of 105 descendants with Gardner syndrom. APC (adenomatous polyposis coli) mutation carriers were screened by endoscopy, and colorectal resection was performed upon pending malignancy. Desmoid tumors were treated by excision or radiotherapy and brachytherapy.
  • Gardner Syndrome
  • Colorectal Carcinoma
  • Desmoid Tumor
Not Provided
Not Provided
Turina M, Pavlik CM, Heinimann K, Behrensmeier F, Simmen HP. Recurrent desmoids determine outcome in patients with Gardner syndrome: a cohort study of three generations of an APC mutation-positive family across 30 years. Int J Colorectal Dis. 2013 Jun;28(6):865-72. doi: 10.1007/s00384-012-1600-x. Epub 2012 Nov 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
December 2010
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01286662
TriemliH
No
Not Provided
Not Provided
Matthias Turina, Triemli Hospital
Triemli Hospital
Not Provided
Principal Investigator: Matthias Turina, MD PhD Triemli Hospital
Study Director: Hans P Simmen, MD University of Zurich Hospital
Triemli Hospital
January 2011
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