UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023879 |
|---|---|
| Receipt number | 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 | 2025/05/03 17:58:04 |
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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
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
shinto@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College and Kyushu University
Institute
Department
Personal name
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
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
https://bmccancer.biomedcentral.com/articles/10.1186/s12885-021-09088-6
Publication of results
Published
Result
URL related to results and publications
https://karger.com/ocl/article-abstract/98/8/534/239371/A-Validation-Study-for-Recurrence-Risk?redir
Number of participants that the trial has enrolled
422
Results
Based on the 55GC, stage II patients were classified into microsatellite instability-like (27%), chromosomal instability-like (41%), and stromal (32%) subtypes with 5-year RFS rates of 88.5, 83.3, and 71.2%, respectively (stromal vs. others: p = 0.0049).
Among stage III patients, Subclassification using 55GC and tumor sidedness revealed increased RFS in patients within the MSI-like subtype with left-sided CC treated with fluoropyrimidine and oxaliplatin compared to those treated without oxaliplatin.
Results date posted
| 2025 | Year | 05 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Retrospectively, 232 stage II colon cancer patients without adjuvant chemotherapy and 190 stage III colon cancer patients with adjuvant chemotherapy who underwent curative surgery between 2009 and 2012 were enrolled.
Participant flow
Formalin-fixed paraffin-embedded (FFPE) primary cancer tissue specimens from 232 stage II colon cancer patients and 190 stage III colon cancer patients were subjected to DNA microarray analysis.
In stage II cancer patients, 5-year relapse-free survival (RFS) rates were compared among 3 subtypes disclosed by 55-gene classifier (55GC) system (microsatellite instability-like, chromosomal instability-like, and stromal subtypes).
In stage III cancer patients, the levels of increased RFS between patients treated with fluoropyrimidine and oxaliplatin and those treated without oxaliplatin were explored according to 55GC system subtypes and tumor sidedness.
Adverse events
N/A because of retrospective observational study.
Outcome measures
In stage II cancer patients, the outcome measure was 5-year relapse-free survival (RFS) rates of 3 subtypes disclosed by 55-gene classifier (55GC) system.
"https://karger.com/ocl/article-abstract/98/8/534/239371/A-Validation-Study-for-Recurrence-Risk?redir"
In stage III cancer patients, the outcome measure was the level of increased RFS between patients treated with fluoropyrimidine and oxaliplatin and those treated without oxaliplatin.
"https://bmccancer.biomedcentral.com/articles/10.1186/s12885-021-09088-6"
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2025 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027349
