Clinical trial NCT01980134: The MORDIS Study Clinical Investigational Plan
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adenoma
Keywords: adenomatous colorectal lesions
colorectal polyps
polyps
Lead sponsor: SpectraScience
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera Universitaria Policlinico
name: European Institute of Oncology
name: Institut des Maladies de l'Appareil digestif
name: European Georges Pompidou Hospital
name: KU Leuven
name: Innere Medizin I Interdisziplinäre Endoskopie Universitätsklinikum Tübingen
name: University of Erlangen-Nürnberg
name: Copenhagen University Hospital at Herlev
name: Skane University Hospital
name: Institute for Clinical and Experimental Medicine
First posted: 2013-11-08
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: \~1200 patients ≥ 18 years of age at the time of enrollment showing presence of diminutive colorectal polyps.

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.

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.

Eligibility 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

Primary outcomes:
measure: To demonstrate potential of the WavSTAT4 Optical Biopsy System to predict adenomatous histology with a NPV > = 90% for diminutive colorectal lesions.
timeFrame: 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 outcomes:
measure: Improved determination of post-polypectomy surveillance intervals
timeFrame: 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.
Other outcomes:
Locations:
city: Praha
country: Czech Republic
facility: Klinika Hepatogastroenterologie Ikem
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Tübingen
country: Germany
facility: Universitäts Klinikum Tübingen
city: Milan
country: Italy
facility: European Institute of Oncology
city: Roma
country: Italy
facility: Policlinico Universitario Gemeli
city: Malmö
country: Sweden
facility: SKANE University Hospital
Study officials:
affiliation: Policlinico Gemeli, Roma, Italy
name: Guido Costamagna, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.