UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021002
Receipt number R000024241
Scientific Title BRAF mutational status in Japanese patients with RAS wild-type metastatic colorectal cancer; a nation-wide multicenter observational study
Date of disclosure of the study information 2016/03/15
Last modified on 2017/08/15 09:16:48

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Basic information

Public title

BRAF mutational status in Japanese patients with RAS wild-type metastatic colorectal cancer; a nation-wide multicenter observational study

Acronym

BRAF mutational status in Japanese patients with RAS wild-type metastatic colorectal cancer; a nation-wide multicenter observational study

Scientific Title

BRAF mutational status in Japanese patients with RAS wild-type metastatic colorectal cancer; a nation-wide multicenter observational study

Scientific Title:Acronym

BRAF mutational status in Japanese patients with RAS wild-type metastatic colorectal cancer; a nation-wide multicenter observational study

Region

Japan


Condition

Condition

Metastatic colorectal adenocarcinoma

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To describe the frequency of BRAF mutation (V600E and non-V600E mutation) using residual samples from the RAS-wild type metastatic colorectal adenocarcinoma, and to clarify the relationships BRAF mutational status, microsatellite instability (MSI), and patient's clinic-pathological characteristics and treatment outcomes.

Basic objectives2

Others

Basic objectives -Others

To describe the frequency of BRAF mutation (V600E and non-V600E mutation)

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Describe frequency of BRAF mutations (V600E and non-V600E mutations) in KRAS/NRAS wild-type metastatic colorectal adenocarcinoma.

Key secondary outcomes



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


Not applicable

Gender

Male and Female

Key inclusion criteria

1)The subject has histologically confirmed colorectal adenocarcinoma.
2)The subject has metastatic or locally advanced disease not amendable to curative surgery.
3)The subject must be currently receiving or prior to first-line chemotherapy.
4)The subject is at least 20 years of age at the time of informed consent.
5)The patient has provided singed informed consent prior to any study specific procedures.

Key exclusion criteria

1)The subject has other malignancies which affect the patients' survival time.
2)The tumor has previously confirmed RAS mutant or BRAF mutant colorectal cancer.
3)The subject is receiving or panning to concomitant radiotherapy for primary site.
4)The subject is not appropriate for this study due to any other reasons.

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroya Taniguchi

Organization

Aichi Cancer Center Hospital

Division name

Department of Clinical Oncology

Zip code


Address

Kanokoden 1-1, Chikusa-ku, Nagoya, Aichi, Japan

TEL

052-762-6111

Email

h.taniguchi@aichi-cc.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroya Taniguchi

Organization

Aichi Cancer Center Hospital

Division name

Department of Clinical Oncology

Zip code


Address

Kanokoden 1-1, Chikusa-ku, Nagoya, Aichi, Japan

TEL

052-762-6111

Homepage URL


Email

h.taniguchi@aichi-cc.jp


Sponsor or person

Institute

Aichi Cancer Center Hospital, Department of Clinical Oncology

Institute

Department

Personal name



Funding Source

Organization

Takeda Pharmaceutical Company Limited

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



Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 15 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

2015 Year 12 Month 21 Day

Date of IRB


Anticipated trial start date

2017 Year 02 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

This is a multicenter, observational study to describe frequency of BRAF mutations (V600E and non V600E mutations), which is primary objective in KRAS NRAS wild type metastatic colorectal adenocarcinoma. The subject must have histologically confirmed, unresectabole colorectal adenocarcinoma. The subject must be currently receiving or prior to first-line chemotherapy. The subject has available archival tumor tissue sufficient for submission to the central laboratory.


Management information

Registered date

2016 Year 02 Month 13 Day

Last modified on

2017 Year 08 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024241


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name