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The MORDIS Study Clinical Investigational Plan (MORDIS)

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ClinicalTrials.gov Identifier: NCT01980134
Recruitment Status : Recruiting
First Posted : November 8, 2013
Last Update Posted : April 14, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To demonstrate the use of WavSTAT4 system during colonoscopy in identifying diminutive colorectal lesions (e.g. hyperplastic polyps) that can be resected and discarded (or even left in-situ) without adverse clinical impact.

Condition or disease
Adenoma

Detailed Description:

To demonstrate the performance of the WavSTAT4 Optical Biopsy System when used at multiple centers.

Endpoint targets are based on the ASGE PIVI recommendations on real-time endoscopic assessment of the histology of diminutive colorectal polyps.

  • Primary endpoint: To demonstrate potential of the WavSTAT4 Optical Biopsy System to predict adenomatous histology with a NPV > = 90% for diminutive colorectal lesions.
  • Secondary Endpoint: To show that use of the WavSTAT4 system used to determine histology of colorectal polyps ≤5 mm in size, when combined with the histo- pathologic assessment of polyps >5 mm in size, provides a ≥ 90% agreement in assignment of post-polypectomy surveillance intervals when compared to decisions based on pathology assessment of all identified polyps.

Study Design

Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Multicenter, Open, Prospective Study on Modified Resect and DIScard Strategy of Small Colonic Lesions Using WavSTAT4 Optical Biopsy System: The MORDIS Study Clinical Investigational Plan
Study Start Date : December 2013
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : November 2016
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. To demonstrate potential of the WavSTAT4 Optical Biopsy System to predict adenomatous histology with a NPV > = 90% for diminutive colorectal lesions. [ Time Frame: WavSTAT4 Optical Biopsy System gives real-time result. Outcomes are measured when comparing the physician and WavSTAT4 system result to pathology results, which usually take one to two weeks. ]
    The WavSTAT4 Optical Biopsy System result will be compared to physician visual diagnosis as well as the subsequent pathological report.


Secondary Outcome Measures :
  1. Improved determination of post-polypectomy surveillance intervals [ Time Frame: Outcome is measured when patients return for routine follow up. which is a long-term study as patients are not usually requested to return for another colonoscopy for many years. ]
    To show that use of the WavSTAT4 system used to determine histology of colorectal polyps ≤5 mm in size, when combined with the histo- pathologic assessment of polyps >5 mm in size, provides a ≥ 90% agreement in assignment of post-polypectomy surveillance intervals when compared to decisions based on pathology assessment of all identified polyps.


Biospecimen Retention:   Samples With DNA
Samples will be sent for pathological examination and potentially used for other research purposes.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
~1200 patients ≥ 18 years of age at the time of enrollment showing presence of diminutive colorectal polyps.
Criteria

Inclusion Criteria:

  • Male and Female > 18 years
  • Standard indication for colonoscopy OR CRC screening OR follow-up examination after the diagnosis of one or more established polyps OR polypectomy (analysis of polyps other than the intended polypectomy)
  • Written informed consent

Exclusion Criteria:

  • Inflammatory bowel disease
  • Hereditary/genetic polyposis syndromes
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): NCT01980134


Contacts
Contact: Guido Costamagna, MD +390630154083 gcostamagna@rm.unicatt.it

Locations
Czech Republic
Klinika Hepatogastroenterologie Ikem Recruiting
Praha, Czech Republic, Praha 4
Contact: MUDR. M. Benes, MD    420 26136 4016      
Contact: Prof. Julius Spicak, MD    420 26136 4016      
Denmark
Herlev Hospital Recruiting
Herlev, Denmark, 2730
Contact: Peter Vilmann, MD    4991318545053    Peter.Vilmann@regionh.dk   
Germany
Universitäts Klinikum Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Martin Götz,, M.D.    +49 7071 29 82162    martin.goetz@med.uni-tuebingen.de   
Contact: Nisar Peter Malek, M.D.    +49 7071 29 82162      
Italy
European Institute of Oncology Recruiting
Milan, Italy, 20141
Contact: Christiano Crosta, MD    + 390257489067    cristiano.crosta@ieo.it   
Principal Investigator: Christiano Crosta, MD         
Policlinico Universitario Gemeli Not yet recruiting
Roma, Italy, 00168
Contact: Guido Costamagna, MD    + 390630154083    gcostamagna@rm.unicatt.it   
Principal Investigator: Guido Costamagna, MD         
Sweden
SKANE University Hospital Recruiting
Malmö, Sweden, SE-205 02
Contact: Ervin Toth, MD    46 40 33 1000/ 33 86 21    ervin.toth@med.lu.se   
Sponsors and Collaborators
SpectraScience
Azienda Ospedaliera Universitaria Policlinico
European Institute of Oncology
Institut des Maladies de l’Appareil digestif
European Georges Pompidou Hospital
Katholieke Universiteit Leuven
Innere Medizin I Interdisziplinäre Endoskopie Universitätsklinikum Tübingen
University of Erlangen-Nürnberg
Copenhagen University Hospital at Herlev
Skane University Hospital
Institute for Clinical and Experimental Medicine
Investigators
Principal Investigator: Guido Costamagna, MD Policlinico Gemeli, Roma, Italy
More Information

Publications:
Responsible Party: SpectraScience
ClinicalTrials.gov Identifier: NCT01980134     History of Changes
Other Study ID Numbers: MORDIS Study 010044-002
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016

Keywords provided by SpectraScience:
adenomatous colorectal lesions
colorectal polyps
polyps

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms