UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036424
Receipt No. R000041290
Scientific Title An observational study to evaluate clinical utility of the pursuit of RAS status using ctDNA analysis to investigate the optimal patient population for anti-EGFR re-challenge therapy
Date of disclosure of the study information 2019/04/18
Last modified on 2019/05/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Best timing of EGFR re-challenge by monitoring the mutant allele of KRAS/NRAS in liquid biopsy
Acronym REMARRY Study
Scientific Title An observational study to evaluate clinical utility of the pursuit of RAS status using ctDNA analysis to investigate the optimal patient population for anti-EGFR re-challenge therapy
Scientific Title:Acronym REMARRY Study
Region
Japan

Condition
Condition Patients with RAS/BRAF V600E wild-type unresectable advanced or recurrent colorectal cancer who have been treated with anti-EGFR monoclonal antibody
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the dynamics of RAS mutational status in patients with RAS/BRAF V600E wild-type unresectable advanced or recurrent colorectal cancer who have been treated with anti-EGFR monoclonal antibody by sequential monitoring using circulating tumor DNA analysis.
Basic objectives2 Others
Basic objectives -Others To explore patients who are effective for anti-EGFR monoclonal antibody re-challenge based on the results of the monitoring.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The dynamics of the positive RAS mutations rate by circulating tumor DNA analysis using OncoBEAM RAS CRC KIT
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) Unresectable advanced colorectal adenocarcinoma confirmed by histological diagnosis.
2) RAS (KRAS/NRAS) and BRAF V600E wild type analyzed by tumor tissue.
3) Participants in GOZILA Study (UMIN000029315).
4) Complete or partial response to previous chemotherapy including anti-EGFR antibody (cetuximab or panitumumab).
5) Documentation of progression to previous anti-EGFR antibody within 2 months after last anti-EGFR antibody administration.
6) Patients who are able to be obtained blood sample before following treatment.
7) ECOG 0 or 1.
8) Age >= 20 year old.
9) Life expectancy of at least 12 weeks.
10) Written informed consent obtained.
Key exclusion criteria 1) Severe comorbidity.
(a) Active multiple cancer
(b) Uncontroled central nervous system or leptomeningeal metastasis
(c) Mental illness or mental symptoms that would interfere with participation in the study
2) Any patients who are regarded as inadequate for anti-EGFR monoclonal antibody re-challenge by investigators.
3) Intolerant to previous irinotecan therapy.
4) Comorbidity or history of severe pulmonary disease.
5) Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test.
6) Active HCV or HIV infection.
7) Any other patients who are regarded as inadequate for study enrollment by investigators.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Hiroya
Middle name
Last name Taniguchi
Organization National Cancer Center Hospital East
Division name Department of Gastroenterology and Gastrointestinal Oncology
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL 04-7133-1111
Email hirtanig@east.ncc.go.jp

Public contact
Name of contact person
1st name Hiromichi
Middle name
Last name Nakajima
Organization National Cancer Center Hospital East
Division name Department of Gastroenterology and Gastrointestinal Oncology
Zip code 2778577
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL 04-7133-1111
Homepage URL
Email hiromina@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

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 NCC IRB office
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
Tel 03-3542-2511
Email NCC_IRBoffice@ml.res.ncc.go.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
2019 Year 04 Month 18 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 Open public recruiting
Date of protocol fixation
2019 Year 03 Month 16 Day
Date of IRB
2019 Year 03 Month 19 Day
Anticipated trial start date
2019 Year 04 Month 18 Day
Last follow-up date
2022 Year 03 Month 31 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 meet the selection criteria until March 31 2020 from research permit date

Management information
Registered date
2019 Year 04 Month 05 Day
Last modified on
2019 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041290

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.