NCT01980134

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Typical duration for all trials

Geographic Reach
5 countries

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
23 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

April 14, 2016

Status Verified

April 1, 2016

Enrollment Period

2.7 years

First QC Date

November 1, 2013

Last Update Submit

April 12, 2016

Conditions

Adenoma

Keywords

adenomatous colorectal lesionscolorectal polypspolyps

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Improved determination of post-polypectomy surveillance intervals

    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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Inflammatory bowel disease
  • Hereditary/genetic polyposis syndromes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Klinika Hepatogastroenterologie Ikem

Prague, Czech Republic, Praha 4, Czechia

RECRUITING

Herlev Hospital

Herlev, 2730, Denmark

RECRUITING

Universitäts Klinikum Tübingen

Tübingen, 72076, Germany

RECRUITING

European Institute of Oncology

Milan, Italy, 20141, Italy

RECRUITING

Policlinico Universitario Gemeli

Roma, Italy, 00168, Italy

NOT YET RECRUITING

SKANE University Hospital

Malmo, SE-205 02, Sweden

RECRUITING

Related Publications (1)

  • 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.

    PMID: 19910250BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Samples will be sent for pathological examination and potentially used for other research purposes.

MeSH Terms

Conditions

AdenomaPolyps

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Guido Costamagna, MD

    Policlinico Gemeli, Roma, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guido Costamagna, MD

CONTACT

+390630154083gcostamagna@rm.unicatt.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2013

First Posted

November 8, 2013

Study Start

December 1, 2013

Primary Completion

August 1, 2016

Study Completion

November 1, 2016

Last Updated

April 14, 2016

Record last verified: 2016-04

Locations

SE(1)IT(2)CZ(1)DE(1)DK(1)