UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031242
Receipt number R000035671
Scientific Title Identification of Site-specific Genome Alterations in Advanced Colorectal Cancer (SCRUM-Japan GI-screen 2013-01-CRC substudy 003)
Date of disclosure of the study information 2018/02/10
Last modified on 2022/08/15 13:44:51

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Basic information

Public title

Identification of Site-specific Genome Alterations in Advanced Colorectal Cancer (SCRUM-Japan GI-screen 2013-01-CRC substudy 003)

Acronym

SCRUM-Japan GI-screen 2013-01-CRC substudy 003

Scientific Title

Identification of Site-specific Genome Alterations in Advanced Colorectal Cancer (SCRUM-Japan GI-screen 2013-01-CRC substudy 003)

Scientific Title:Acronym

SCRUM-Japan GI-screen 2013-01-CRC substudy 003

Region

Japan


Condition

Condition

Advanced colorectal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To determine the site-specific gene mutation profiles in advanced colorectal cancer.

Basic objectives2

Others

Basic objectives -Others

Association between site-specific gene mutation profiles and clinical background, including therapeutic efficacy of anti-EGFR therapies or anti-angiogenic agents

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

site-specific gene mutation profiles in advanced colorectal cancer

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients enrolled in SCRUM-Japan GI-Screen 2013-01-CRC from Feb. 2015 on, and whose cancer genome alterations were decided by OCP.
2)Patients who agreed to the secondary usage of specimen when they agreed to GI-Screen 2013-01-CRC, and did not revoked their agreements.

Key exclusion criteria

1)Patients whose specimens were collected from metastatic site or unknown.
2)Patients who have administerd chemotherapy, including anti-EGFR therapies or anti-angiogenetic agents for metastatic disease before collecting the specimens.
3)Judged by the investigator to be inappropriate for study participation for any reason

Target sample size

1011


Research contact person

Name of lead principal investigator

1st name Takako
Middle name Eguchi
Last name Takako

Organization

St. Marianna University School of Medicine

Division name

Clinical Oncology

Zip code

2168511

Address

Sugao 2-16-1, Miyamae, Kawasaki, Kanagawa, Japan

TEL

044-977-8111

Email

tnakajima@marianna-u.ac.jp


Public contact

Name of contact person

1st name Takuro
Middle name
Last name Takuro

Organization

St. Marianna University School of Medicine

Division name

Clinical Oncology

Zip code

2168511

Address

Sugao 2-16-1, Miyamae, Kawasaki, Kanagawa, Japan

TEL

044-977-8111

Homepage URL


Email

t3mizukami@marianna-u.ac.jp


Sponsor or person

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

SCRUM Funds

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor

National Cancer Center Hospital East

Name of secondary funder(s)



IRB Contact (For public release)

Organization

St. Marianna University School

Address

Sugao 2-16-1, Miyamae, Kawasaki, Kanagawa

Tel

044-977-8111

Email

t3mizukami@marianna-u.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



Other administrative information

Date of disclosure of the study information

2018 Year 02 Month 10 Day


Related information

URL releasing protocol

https://doi.org/10.1007/s11523-022-00880-3

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1007/s11523-022-00880-3

Number of participants that the trial has enrolled

569

Results

Patients with right-sided tumors had worse survival,left-sided tumors with wt RAS had favorable outcomes when treated with anti-EGFR antibodies and cecum tumors had a poor prognosis when treated with bevacizumab. The rate of gene alterations varied depending on the primary site. In addition, gene alterations of KRAS, BRAF, SMAD4, or TP53 had different contributions to survival from site to site. KRAS, BRAF, PTEN, or SMAD4 mutations were associated with the efficacy of bevacizumab or anti-EGFR mAb.

Results date posted

2022 Year 08 Month 15 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The relationship between PTS, genomic alterations, and clinical outcomes was evaluated in untreated mCRC patients using real-world data of a prospective observational study, SCRUM-Japan GI-SCREEN with clinical and genomic data set in 1,011 patients enrolled from February 2015 to March 2017.

Participant flow

NA

Adverse events

NA

Outcome measures

NA

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 04 Month 19 Day

Date of IRB

2017 Year 04 Month 19 Day

Anticipated trial start date

2017 Year 05 Month 17 Day

Last follow-up date

2017 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study Design: Observational study
Target population:the patients who enrolled GI-SCREEN 2013-01-CRC from Feb. 2015 and meet the selection criteria.


Management information

Registered date

2018 Year 02 Month 10 Day

Last modified on

2022 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=R000035671


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name