UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000036424 |
|---|---|
| Receipt number | 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 | 2022/04/09 15:28:40 |
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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
180
Research contact person
Name of lead principal investigator
| 1st name | Hiroya |
| Middle name | |
| Last name | Taniguchi |
Organization
Aichi cancer center hospital
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1, Kanokoden, Nagoya Chikusa-ku, Aichi, 464-8681, Japan
TEL
052-762-6111
hiroya.taniguchi@aichi-cc.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 experimental therapeutics
Zip code
2778577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
04-7133-1111
Homepage URL
hiromina@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
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
NCC IRB office
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
Tel
03-3542-2511
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
180
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
No longer 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
| 2023 | 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
| 2022 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041290
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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