UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044539
Receipt number R000050572
Scientific Title A pilot study of the color difference between colorectal polyp and the surrounding normal mucosa in the latest and the newly launched OLYMPUS endoscopy system
Date of disclosure of the study information 2021/06/15
Last modified on 2021/06/15 08:26:43

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Basic information

Public title

A pilot study of the color difference between colorectal polyp and the surrounding normal mucosa in the latest and the newly launched OLYMPUS endoscopy system

Acronym

X1 study

Scientific Title

A pilot study of the color difference between colorectal polyp and the surrounding normal mucosa in the latest and the newly launched OLYMPUS endoscopy system

Scientific Title:Acronym

X1 study

Region

Japan


Condition

Condition

Colorectal polyps

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the color differences between the polyp and the surrounding normal mucosa in white light and narrow band imaging of the LUCERA and the X1 system

Basic objectives2

Others

Basic objectives -Others

The efficacy

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

The color differences

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Cases with one or more colorectal polyps, which were detected, observed, and removed using the LUCERA and X1 colonoscopy

Key exclusion criteria

Polyps lacking images either of white light or NBI, sub-epithelial lesions, advanced-stage cancer, pedunculated polyp

Target sample size

84


Research contact person

Name of lead principal investigator

1st name Kenichiro
Middle name
Last name Imai

Organization

Shizuoka Cancer Center

Division name

Division of Endoscopy

Zip code

4118777

Address

1007 Shimonagakubo, Nagaizumi-cyo, Sunto-gun, Shizuoka, Japan

TEL

81-055-989-5222

Email

ke.imai@scchr.jp


Public contact

Name of contact person

1st name Kenichiro
Middle name
Last name Imai

Organization

Shizuoka Cancer Center

Division name

Division of Endoscopy

Zip code

4118777

Address

1007 Shimonagakubo, Nagaizumi-cyo, Sunto-gun, Shizuoka, Japan

TEL

81-055-989-5222

Homepage URL


Email

ke.imai@scchr.jp


Sponsor or person

Institute

Shizuoka Cancer Center

Institute

Department

Personal name



Funding Source

Organization

Shizuoka Cancer Center

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shizuoka Cancer Center Research promotion group

Address

1007 Shimonagakubo, Nagaizumi-cyo, Sunto-gun, Shizuoka, Japan

Tel

81-055-989-5222

Email

irb@scchr.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2021 Year 06 Month 15 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

84

Results

NBI showed a higher deltaE00 than WLI both in LUCERA (6.06 vs. 4.87, p= 0.01) and X1 (8.24 vs. 6.00, p< 0.01). In comparison between LUCERA and X1, no significant differences were found in WLI (p= 0.20), whereas the X1 NBI had a significantly higher deltaE00 than the LUCERA NBI (p< 0.01).

Results date posted

2021 Year 06 Month 14 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The median size of polyps was similar. Size categories and pathology were well matched.

Participant flow

During the study period, out of 86 polyps detected in 28 colonoscopies using the X1 and CF-EZ1500, 42 polyps were enrolled in the X1 group. After matching, 42 polyps were enrolled in the LUCERA group.

Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2020 Year 10 Month 25 Day

Date of IRB

2021 Year 06 Month 10 Day

Anticipated trial start date

2021 Year 06 Month 11 Day

Last follow-up date

2021 Year 06 Month 11 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Between July 19 and August 29, 2020, polyps detected, observed, and removed at our center using CF-EZ 1500 (Olympus, Tokyo, Japan) with X1 CV-1500 (X1, Olympus) or CF-HQ290ZI (Olympus) with LUCERA CV-290 (LUCERA, Olympus) were studied. Pedunculated polyps, polyps lacking non-magnified WLI or NBI images, polyps with poor-quality images, advanced-stage cancer, or sub-epithelium lesions were excluded.


Management information

Registered date

2021 Year 06 Month 15 Day

Last modified on

2021 Year 06 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050572


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name