Risk Factors for Residual Neoplasia After Endoscopic Mucosal Resection

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Premysl Falt MD, Vitkovice Hospital

ClinicalTrials.gov Identifier:

NCT01478919

First received: November 21, 2011

Last updated: November 22, 2011

Last verified: November 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	November 21, 2011
Last Updated Date	November 22, 2011
Start Date ^ICMJE	January 2010
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 22, 2011)	Occurence of Local Residual Neoplasia (LRN) [ Time Frame: 3 months ] [ Designated as safety issue: No ] LRN was defined as a histologically confirmed neoplastic tissue in the biopsy samples obtained from post-resection scar during follow-up colonoscopy 3 months after endoscopic resection
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01478919 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 22, 2011)	Evaluation of Selected Risk Factors for Local Residual Neoplasia (LRN) [ Time Frame: 3 months ] [ Designated as safety issue: No ] Evaluation of selected patient- and lesion-related risk factors associated with LRN (gender, age, lesion size, location, morphology, pit pattern, histology, type of resection, and others)
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Risk Factors for Residual Neoplasia After Endoscopic Mucosal Resection
Official Title ^ICMJE	Risk Factors for Local Residual Neoplasia After Convetional Endoscopic Mucosal Resection of Laterally Spreading Tumors
Brief Summary	Laterally Spreading Tumors (LST) are important precursosrs of invasive colorectal cancer. Endoscopic treatment has replaced surgery in most of the cases. Nevertheless, after conventional Endoscopic Mucosal Resection (CER), Local Residual Neoplasia (LRN) is an issue. Therefore, endoscopic follow-up and treatment are necessary. To decrease its occurrence, the risk factors of LRN shoudl be identified. Thereafter, in high-risk patients, other modalities of initial treatment including Endoscopic Submucosal Dissection (ESD) and surgical treatment, could be considered. The purpose of this prospective study is to identify risk factors associated with the presence of LRN after CER of LSTs.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients referred for Endoscopic Mucosal Resection (EMR) of Laterally Spreading Tumors (LST.)
Condition ^ICMJE	Colorectal Cancer
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	127
Completion Date	November 2011
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: all consecutive patients referred for EMR of LST Exclusion Criteria: polyposis syndromes previous therapeutic attempt
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Czech Republic

Administrative Information
NCT Number ^ICMJE	NCT01478919
Other Study ID Numbers ^ICMJE	DDC VN 02
Has Data Monitoring Committee	No
Responsible Party	Premysl Falt MD, Vitkovice Hospital
Study Sponsor ^ICMJE	Vitkovice Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Vitkovice Hospital
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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