We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
  Purpose
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.

Condition
Gardner Syndrome Colorectal Carcinoma Desmoid Tumor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Triemli Hospital:

Primary Outcome Measures:
  • mortality [ Time Frame: 1978-2010 (as long as patients live) ]

Secondary Outcome Measures:
  • incidence of colorectal carcinoma [ Time Frame: 1978-2010 (entire patient life) ]
  • Incidence of desmoid tumors [ Time Frame: 1978-2010 (entire patient life) ]

Enrollment: 105
Study Start Date: January 1978
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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 BT/RT, all patients showed full or partial remission.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01286662


Sponsors and Collaborators
Triemli Hospital
Investigators
Principal Investigator: Matthias Turina, MD PhD Triemli Hospital
Study Director: Hans P Simmen, MD University of Zurich Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Matthias Turina, Triemli Hospital
ClinicalTrials.gov Identifier: NCT01286662     History of Changes
Other Study ID Numbers: TriemliH
First Submitted: January 25, 2011
First Posted: January 31, 2011
Last Update Posted: January 31, 2011
Last Verified: January 2011

Keywords provided by Triemli Hospital:
gardner syndrome
colorectal carcinoma
desmoid tumor
resection
colon

Additional relevant MeSH terms:
Syndrome
Colorectal Neoplasms
Fibromatosis, Aggressive
Adenomatous Polyposis Coli
Gardner Syndrome
Disease
Pathologic Processes
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Adenomatous Polyps
Adenoma
Neoplasms, Glandular and Epithelial
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Genetic Diseases, Inborn
Abnormalities, Multiple
Congenital Abnormalities