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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024159
Receipt No. R000027743
Scientific Title A study to determine a correction coefficient for the introduction of 55-gene classifier (55GC) into clinical practice, aimed at predicting the recurrence risk in Stage II/III colon cancer
Date of disclosure of the study information 2016/09/30
Last modified on 2016/09/25

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Basic information
Public title A study to determine a correction coefficient for the introduction of 55-gene classifier (55GC) into clinical practice, aimed at predicting the recurrence risk in Stage II/III colon cancer
Acronym A study to determine a correction coefficient for the introduction of 55-gene classifier (55GC) into clinical practice, aimed at predicting the recurrence risk in Stage II/III colon cancer
Scientific Title A study to determine a correction coefficient for the introduction of 55-gene classifier (55GC) into clinical practice, aimed at predicting the recurrence risk in Stage II/III colon cancer
Scientific Title:Acronym A study to determine a correction coefficient for the introduction of 55-gene classifier (55GC) into clinical practice, aimed at predicting the recurrence risk in Stage II/III colon cancer
Region
Japan

Condition
Condition Colon cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To explore and determine a correction coefficient for subtype classification based on 55-gene classifier (55GC), using formalin-fixed and paraffin-embedded (FFPE) samples within a few months after surgery for Stage II/III colon cancer, in accordance with clinical practice.
Basic objectives2 Others
Basic objectives -Others To investigate differences between the determined correlation coefficient and that calculated from the cohorts of a retrospective multi-site observational study of 55-gene classifier that will be conducted separately.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To examine the mean expression levels of each gene that comprises 55-gene classifier together with the standard deviation.
Key secondary outcomes To examine differences between the determined correlation coefficient and that calculated from the cohorts of a retrospective multi-site observational study of 55-gene classifier that will be conducted separately.

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
20 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria (1) Patients who underwent curative resection (R0) of stage II or stage III colon cancer (including rectosigmoid cancer), with lymph node dissection (D2 or D3), during the period between the date of approval and 2018.
(2) Patients aged 20-79 years.
(3) Patients who were histologically diagnosed with primary Stage II colon adenocarcinoma, and patients who were histologically diagnosed with primary Stage III colon adenocarcinoma.
Key exclusion criteria (1) Patients who had received preoperative therapy.
(2) Patients with a previous malignancy, within 5 years of operation, except for tumors at the stage of carcinoma in situ.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo HASE
Organization National Defense Medical College Hospital
Division name Director
Zip code
Address 3-2, Namiki, Tokorozawa, Saitama 359-8513 JAPAN
TEL 04-2995-1637
Email shinto@ndmc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji SHINTO
Organization National Defense Medical College
Division name Department of Surgery
Zip code
Address 3-2, Namiki, Tokorozawa, Saitama 359-8513 JAPAN
TEL 04-2995-1637
Homepage URL
Email shinto@ndmc.ac.jp

Sponsor
Institute National Defense Medical College and Kyushu University
Institute
Department

Funding Source
Organization Sysmex Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 防衛医科大学校(埼玉県)、九州大学(福岡県)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 30 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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 01 Month 29 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will publish the results of this study after we examine the correction coefficient for the introduction of 55-gene classifier (55GC) into clinical practice

Management information
Registered date
2016 Year 09 Month 25 Day
Last modified on
2016 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027743

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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