UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024159 |
|---|---|
| Receipt number | 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 | 2025/05/03 18:12:40 |
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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 | 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
359-8513
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
Tel
0429951511
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）
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
| 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=R000027743
