Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Diverticular Disease on the Detection of Colon Adenomas (DECADE)

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.
 
ClinicalTrials.gov Identifier: NCT02057562
Recruitment Status : Unknown
Verified November 2016 by Dr. Peter Klare, Technische Universität München.
Recruitment status was:  Active, not recruiting
First Posted : February 7, 2014
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Peter Klare, Technische Universität München

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Benign adenomas of the colon have the potential to degenerate and become malignant. Therefore adenomatous polyps should be detected and resected during colonoscopy. Factors like advanced age and male gender are associated with the detection of adenomas. The same epidemiological pattern can be found with regard to colon diverticula. Furthermore, western world countries report higher incidences of both colorectal carcinoma as well as diverticular disease. It is not known whether a correlation exists between both entities. Some recent data have postulated higher adenoma detection rates in patients with concomitant diverticular disease (Rondagh EJ et al. Eur J Gastroenterol Hepatol. 2011; 23:1050-5. Kieff BJ et al. Am J Gastroenterol 2004; 99: 2007-11). If a positive correlation could be found this would possibly affect recommendations regarding colonoscopy surveillance intervals for patients with and without diverticular disease. The investigators therefore plan to conduct the following trial.

Condition or disease
Colon Adenoma Diverticulosis

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : February 2014
Actual Primary Completion Date : September 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Routine colonoscopy
Patients receiving routine colonoscopy (for a multitude of indications) at the study centers are eligible for participation


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Adenoma detection rate [ Time Frame: up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks) ]
    After obtaining the histopathological diagnosis of resected polyps (approximately 3 days - 2 weeks after colonoscopy ) accuracy of optical diagnosis can be determined


Secondary Outcome Measures :
  1. Polyp detection rate [ Time Frame: up to one day ]
    a maximum of one day is expected for colonoscopy

  2. Frequency of colon diverticulosis [ Time Frame: up to one day ]
    a maximum of one day is expected for colonoscopy


Biospecimen Retention:   Samples Without DNA
Colon polyps and mucosa

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients receiving routine colonoscopy at the both study centers are eligible for participation.
Criteria

Inclusion Criteria:

  • indication for colonoscopy
  • age >= 18 years

Exclusion Criteria:

  • pregnant women
  • patients denying written consent
  • indication for colonoscopy: familial adenomatous polypose
  • indication for colonoscopy: inflammatory bowel disease
  • indication for colonoscopy: previously known colon polyp/adenoma/carcinoma
  • history of colon surgery
  • contraindication for resection of polyps
  • American Society of Anesthesiologists (ASA) class IV, V or VI
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02057562


Locations
Layout table for location information
Germany
Rotkreuzklinikum München
München, Deutschland, Germany, 80634
II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
München, Deutschland, Germany, 81677
Sponsors and Collaborators
Technische Universität München
Investigators
Layout table for investigator information
Principal Investigator: Peter Klare, MD II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany
Study Chair: Peter Born, Prof. Dr. Innere Medizin II, Rotkreuzklinikum München, Nymphenburger Str. 163, München, Germany
Study Director: Stefan von Delius, MD II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Dr. Peter Klare, MD, Technische Universität München
ClinicalTrials.gov Identifier: NCT02057562    
Other Study ID Numbers: DECADE
First Posted: February 7, 2014    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016
Keywords provided by Dr. Peter Klare, Technische Universität München:
Adenoma
Diverticular disease
Diverticulosis
Colorectal carcinoma
Polyp
Additional relevant MeSH terms:
Layout table for MeSH terms
Diverticular Diseases
Diverticulum
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical