The MORDIS Study Clinical Investigational Plan (MORDIS)

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

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.

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

• Study Contact: Name: Guido Costamagna, MD; Phone Number: +390630154083; Email: gcostamagna@rm.unicatt.it

Study Locations

• Czech Republic
  • Praha, Czech Republic, Praha 4
    • Recruiting
    • Klinika Hepatogastroenterologie Ikem
    • Contact: MUDR. M. Benes, MD; Phone Number: 420 26136 4016
    • Contact: Prof. Julius Spicak, MD; Phone Number: 420 26136 4016
• Denmark
  • Herlev, Denmark, 2730
    • Recruiting
    • Herlev Hospital
    • Contact: Peter Vilmann, MD; Phone Number: 4991318545053; Email: Peter.Vilmann@regionh.dk
• Germany
  • Tübingen, Germany, 72076
    • Recruiting
    • Universitäts Klinikum Tübingen
    • Contact: Martin Götz,, M.D.; Phone Number: +49 7071 29 82162; Email: martin.goetz@med.uni-tuebingen.de
    • Contact: Nisar Peter Malek, M.D.; Phone Number: +49 7071 29 82162
• Italy
  • Milan, Italy, 20141
    • Recruiting
    • European Institute of Oncology
    • Contact: Christiano Crosta, MD; Phone Number: + 390257489067; Email: cristiano.crosta@ieo.it
    • Principal Investigator: Christiano Crosta, MD
  • Roma, Italy, 00168
    • Not yet recruiting
    • Policlinico Universitario Gemeli
    • Principal Investigator: Guido Costamagna, MD
    • Contact: Guido Costamagna, MD; Phone Number: + 390630154083; Email: gcostamagna@rm.unicatt.it
• Sweden
  • Malmö, Sweden, SE-205 02
    • Recruiting
    • Skåne University Hospital
    • Contact: Ervin Toth, MD; Phone Number: 46 40 33 1000/ 33 86 21; Email: ervin.toth@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

~1200 patients ≥ 18 years of age at the time of enrollment showing presence of diminutive colorectal polyps.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To demonstrate potential of the WavSTAT4 Optical Biopsy System to predict adenomatous histology with a NPV > = 90% for diminutive colorectal lesions.	The WavSTAT4 Optical Biopsy System result will be compared to physician visual diagnosis as well as the subsequent pathological report.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved determination of post-polypectomy surveillance intervals	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.	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.

Collaborators and Investigators

• Sponsor: SpectraScience
• Collaborators: Azienda Ospedaliera Universitaria Policlinico; KU Leuven; University of Erlangen-Nürnberg; Copenhagen University Hospital at Herlev; Institute for Clinical and Experimental Medicine; Skane University Hospital; European Institute of Oncology; European Georges Pompidou Hospital; Institut des Maladies de l'Appareil digestif; Innere Medizin I Interdisziplinäre Endoskopie Universitätsklinikum Tübingen
• Investigators: Principal Investigator: Guido Costamagna, MD, Policlinico Gemeli, Roma, Italy

Publications and helpful links

General Publications

• Ignjatovic A, East JE, Suzuki N, Vance M, Guenther T, Saunders BP. Optical diagnosis of small colorectal polyps at routine colonoscopy (Detect InSpect ChAracterise Resect and Discard; DISCARD trial): a prospective cohort study. Lancet Oncol. 2009 Dec;10(12):1171-8. doi: 10.1016/S1470-2045(09)70329-8. Epub 2009 Nov 10.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): November 1, 2016

Study Registration Dates

• First Submitted: November 1, 2013
• First Submitted That Met QC Criteria: November 7, 2013
• First Posted (Estimate): November 8, 2013

Study Record Updates

• Last Update Posted (Estimate): April 14, 2016
• Last Update Submitted That Met QC Criteria: April 12, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: polyps; colorectal polyps; adenomatous colorectal lesions
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: MORDIS Study 010044-002