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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009395
Receipt No. R000011037
Scientific Title Confirmatory Study of Oncotype DX Colon Cancer Assay to Assess the Relationship between Continuous Recurrence Score and the Likelihood of Recurrence in Patients with Resected Stage II and Stage III Colon Cancer
Date of disclosure of the study information 2012/11/27
Last modified on 2014/06/26

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Basic information
Public title Confirmatory Study of Oncotype DX Colon Cancer Assay to
Assess the Relationship between Continuous Recurrence Score and the Likelihood of Recurrence
in Patients with Resected Stage II and Stage III Colon Cancer
Acronym SUNRISE
Scientific Title Confirmatory Study of Oncotype DX Colon Cancer Assay to
Assess the Relationship between Continuous Recurrence Score and the Likelihood of Recurrence
in Patients with Resected Stage II and Stage III Colon Cancer
Scientific Title:Acronym SUNRISE
Region
Japan

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

Objectives
Narrative objectives1 To confirm whether Oncotype DX Colon Cancer Assay predicts the risk of recurrence in patients with the StageII and StageIII colon cancer whom the surgical resection was done (surgery alone) in Japan
Basic objectives2 Others
Basic objectives -Others To confirm whether Oncotype DX Colon Cancer Assay predicts the risk of recurrence in patients with the StageII and StageIII colon cancer whom the surgical resection was done (surgery alone) in Japan with cohort sampling design.
To classify the cases of cancer tissues of preservation FFPE into the low risk, the intermediate risk, and the high risk according to RS calculated with Oncotype DX Colon Cancer Assay.
To determine the relationship between RS and the risk of recurrence of Stage II and Stage III colon cancer (surgery alone).
To conduct univariate and the multivariate analyses using covariates of known clinicopathologic prognosis factors and MMR genes.
To examine whether RS can become the independent prognosis factor.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes To consider the relationship between RS calculated by Oncotype DX Colon Cancer Assay in stage II and stage III colon cancer cases, and RFI* in Japanese.
Key secondary outcomes To classify patients into the low risk, the intermediate risk, and the high risk according to RS, and test the hypothesis that the risk of recurrence of the patients of the high risk group is significantly high, compared with the patients of the low risk group.
To examine the prognosis factor (RFS, DFS and OS) using the cohort on step 1.
Relationship between RS and the risk of recurrence in a clinicopathologic factor.
Relationship between RS and Alternative Clinical Endpoints.
Relationship between Individual Genes, Gene groups, and Recurrence Risk.

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
80 years-old >=
Gender Male and Female
Key inclusion criteria (1) Patients who had stage II or stage III colon cancer surgery (including rectosigmoid cancer ) from 2000 to 2005 and who underwent resection of a colon cancer including lymph node dissection &#8805; D2
(2) Patients who aged &#8805;20 and &#8804;80.
(3) Patients who are histologically diagnosed with primary colon adenocarcinoma
(4) Patients with sufficient FFPE sample
(5) Surgery alone (patients who had no Postoperative Chemotherapy)
Key exclusion criteria (1)Patients who have previously the preoperative chemotherapy, immunotherapy or radiation therapy.
(2)Patients with appendix cancer
(3)Patients with history of a malignant tumor
(4)Patients with Familial Adenomatous Polyposis
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayuki YOSHINO
Organization National Cancer Center Hospital East
Division name Department of Gastroenterology & Gastrointestinal Oncology
Zip code
Address 6-5-1, Kashiwanoha, Kashiwashi, Chiba 277-8577 JAPAN
TEL 04-7133-1111
Email sunrise@crsu.org

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuko MOURI
Organization Japan Clinical Research Support Unit
Division name Coodinate Devision
Zip code
Address Ochanomizu-Kimura Bldg. 3F2-19-3, Sotokanda, Chiyoda-ku, Tokyo101-0021 JAPAN
TEL 03-3254-8028
Homepage URL http://www.crsu.org/
Email sunrise@crsu.org

Sponsor
Institute Japan Clinical Research Support Unit
Institute
Department

Funding Source
Organization SRL, Inc.
Genomic Health Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JAPAN, US

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 国立がん研究センター東病院(千葉県)、静岡県立静岡がんセンター(静岡県)、埼玉県立がんセンター(埼玉県)、愛知県がんセンター中央病院(愛知県)、北里大学医学部(神奈川県)、大阪赤十字病院(大阪府)、関西ろうさい病院(大阪府)、四国がんセンター(愛媛県)、大阪医療センター(大阪府)、九州大学大学院(福岡県)、九州医療センター(福岡県)、北野病院(大阪府)、東京医科歯科大学大学院(東京都)

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 27 Day

Related information
URL releasing protocol http://www.crsu.org/
Publication of results Unpublished

Result
URL related to results and publications http://www.crsu.org/
Number of participants that the trial has enrolled
Results
RS
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 No longer recruiting
Date of protocol fixation
2012 Year 10 Month 17 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 01 Day
Last follow-up date
2014 Year 03 Month 30 Day
Date of closure to data entry
2014 Year 06 Month 30 Day
Date trial data considered complete
2014 Year 06 Month 30 Day
Date analysis concluded
2014 Year 09 Month 30 Day

Other
Other related information Whether Oncotype DX Colon Cancer Assay predicts the risk of recurrence in patients with the StageII and StageIII colon cancer whom the surgical resection was done (surgery alone) in Japan?

Management information
Registered date
2012 Year 11 Month 26 Day
Last modified on
2014 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011037

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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