UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043442 |
|---|---|
| Receipt number | R000049609 |
| Scientific Title | An observational study to evaluate RAS mutation in circulating-tumor DNA after chemotherapies in metastatic colorectal cancer patients with tumors harboring RAS mutation |
| Date of disclosure of the study information | 2021/02/26 |
| Last modified on | 2022/01/26 21:58:10 |
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Basic information
Public title
An observational study to evaluate RAS gene status in blood in advanced colorectal cancer patients with RAS Mutation
Acronym
JACCRO CC-17
Scientific Title
An observational study to evaluate RAS mutation in circulating-tumor DNA after chemotherapies in metastatic colorectal cancer patients with tumors harboring RAS mutation
Scientific Title:Acronym
JACCRO CC-17
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the frequency of RAS wild in ctDNA and mutation allele frequency of RAS mutation in ctDNA, and the efficacy and prognosis of standard chemotherapies according to RAS gene status in ctDNA for metastatic colorectal cancer patients
with tumors harboring RAS mutation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the frequency of RAS wild in ctDNA
Key secondary outcomes
(1) mutation allele frequency of RAS mutation in ctDNA
(2) regarding all chemotherapies in enrolled patients
overall response rate:ORR
disease control rate:DCR
overall survival:OS
progression-free survival:PFS
(3) regarding anti-EGFR antibody containing regimen in enrolled patients
treatment cycle
safety
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) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
(2) unresectable or metastatic colorectal cancer
(3) histopathologically confirmed adenocarcinoma with RAS wild-type
(4) 20 years and more at informed consent
(5) refractory disease or unable to tolerate after gained the response of fluoropyrimidine containing regimen
(6) schedule the testing of OncoBEAMTM RAS CRC kit
(7) An estimated life expectancy of at least 90 days after enrollment
(8) Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria
(1) Another malignancy with less than 5 disease-free years
(2) Patients whose participation in the trial was judged to be inappropriate by the attending doctor
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | IZAWA |
Organization
St. Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
n2izawa@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | IZAWA |
Organization
St. Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
Homepage URL
n2izawa@marianna-u.ac.jp
Sponsor or person
Institute
Japan Clinical Cancer Research Organization (JACCRO)
Institute
Department
Personal name
Funding Source
Organization
Sysmex Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Clinical Cancer Research Organization (JACCRO)
Address
6F Jimbocho Kyowa Bldg. 1-64 Kanda-Jimbocho, Chiyoda-ku, Tokyo 101-0051, Japan
Tel
03-6811-0433
irb_jaccro@jaccro.or.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
聖マリアンナ医科大学病院（神奈川県）他
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 26 | 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
| 2021 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
Not applicable
Management information
Registered date
| 2021 | Year | 02 | Month | 25 | Day |
Last modified on
| 2022 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049609
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
