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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023879
Receipt No. R000027349
Scientific Title Validation study of the recurrence risk stratification using 55-gene classifier (55GC) and RAS mutation in StageII/III colon cancer
Date of disclosure of the study information 2016/09/01
Last modified on 2019/09/11

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Basic information
Public title Validation study of the recurrence risk stratification using 55-gene classifier (55GC) and RAS mutation in StageII/III colon cancer
Acronym Validation study of the recurrence risk stratification using 55-gene classifier (55GC) and RAS mutation in StageII/III colon cancer
Scientific Title Validation study of the recurrence risk stratification using 55-gene classifier (55GC) and RAS mutation in StageII/III colon cancer
Scientific Title:Acronym Validation study of the recurrence risk stratification using 55-gene classifier (55GC) and RAS mutation in StageII/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 confirm the usefulness of the 55-gene classifier (55GC) and RAS mutation as a predictor of recurrence risk in patients with Stage II and Stage III colon cancer
Basic objectives2 Others
Basic objectives -Others We plan to conduct a retrospective, multi-institutional study using formalin-fixed, paraffin-embedded cancer tissue to validate whether the novel 55-gene classifier (55GC) and RAS family mutation analysis can predict the recurrence risk for Stage II colon cancer without adjuvant chemotherapy, and Stage III colon cancer with adjuvant chemotherapy.
To confirm the significance of 55GC, we will use multivariate analyses with known clinicopathological prognostic factors and gene mutations as covariates.
To investigate the discriminating power of known multiplex genetic tests as risk predictors, and compare this with 55 GC.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes To examine the relationship between recurrence risk stratification using 55-gene classifier (55GC) and RAS mutation, and recurrence-free, disease-free or overall survival in stage II and stage III colon cancer cases.
Key secondary outcomes To examine the significance of clinicopathological factors, gene mutations, and multiplex genomic tests as predictors of colon cancer recurrence risk.
To investigate the novelty and independence of the 55-gene classifier and RAS family mutation as a risk factor.
To examine whether novel procedures can evaluate the effect of oxaliplatin-based adjuvant chemotherapy.

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), from 2009 to 2012.
(2) Patients aged 20- 79 years.
(3) Patients who were histologically diagnosed with primary Stage II colon adenocarcinoma and did not receive adjuvant chemotherapy, and patients who were histologically diagnosed with primary Stage III colon adenocarcinoma and received adjuvant chemotherapy.
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.
(3) Patients who had recurrence or died within 60 days of surgery.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Kazuo
Middle name
Last name HASE
Organization National Defense Medical College Hospital
Division name Director
Zip code 359-8513
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 Eiji
Middle name
Last name SHINTO
Organization National Defense Medical College
Division name Department of Surgery
Zip code 59-8513
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 National Defense Medical College
Address 3-2, Namiki, Tokorozawa, Saitama 359-8513 JAPAN
Tel 0429951637
Email shinto@ndmc.ac.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 防衛医科大学校(埼玉県)、九州大学(福岡県)、兵庫医科大学(兵庫県)、東京医科歯科大学(東京都)、東北大学(宮城県)、帝京大学(東京都)、埼玉医科大学国際医療センター(埼玉県)、社会医療法人社団高野会高野病院(熊本県)、国立病院機構九州がんセンター(福岡県)、国立病院機構九州医療センター(福岡県)、栃木県立がんセンター(栃木県)、埼玉医科大学総合医療センター(埼玉県)、恩賜財団済生会横浜市南部病院(神奈川県)、神奈川県立病院機構神奈川県立がんセンター(神奈川県)、新潟県立がんセンター新潟病院(新潟県)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 01 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 02 Month 01 Day
Date of IRB
2017 Year 09 Month 28 Day
Anticipated trial start date
2016 Year 06 Month 01 Day
Last follow-up date
2016 Year 09 Month 01 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information We will publish the results of this study after we examine the usefulness of recurrence risk stratification using the 55-gene classifier (55GC) and RAS mutation in patients with Stage II and Stage III colon cancer.

Management information
Registered date
2016 Year 08 Month 31 Day
Last modified on
2019 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027349

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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