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 2016/09/25 22:38:23

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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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027743


Research Plan
Registered date File name

Research case data specifications
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Research case data
Registered date File name