UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038575 |
|---|---|
| Receipt number | R000043948 |
| Scientific Title | Evaluation of RAS gene status in circulating tumor DNA for colorectal cancer patients with RASg gene mutation |
| Date of disclosure of the study information | 2019/11/13 |
| Last modified on | 2021/11/14 13:12:57 |
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Basic information
Public title
Evaluation of RAS gene status in circulating tumor DNA for colorectal cancer patients with RASg gene mutation
Acronym
Evaluation of RAS gene status in ctDNA for colorectal cancer patients with RASg gene mutation
Scientific Title
Evaluation of RAS gene status in circulating tumor DNA for colorectal cancer patients with RASg gene mutation
Scientific Title:Acronym
Evaluation of RAS gene status in ctDNA for colorectal cancer patients with RASg gene mutation
Region
| Japan |
Condition
Condition
metastatic colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the allele frequency of RAS gene mutation in circulating tumor DNA for metastatic colorectal cancer patients who previously were treated with standard chemotherapy
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the allele frequency of RAS gene mutation in circulating tumor DNA
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 with histopathologically confirmed unresecable or metastatic colorectal adenocarcinoma
2) Wild-type RAS status
3) Patients with refractory or unable to tolerate agents (fluoropyrimidines, irinotecan, oxaliplatin and bevacizumab), and refractory to anti-EGFR antibodies (cetuximab and panitumumab)
Key exclusion criteria
No willingness to sign a written informed consent documen
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Sunakawa |
Organization
St. Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
2160015
Address
2-16-1 Sugao Miyamaeku, Kawasaki
TEL
0449778111
y.sunakawa@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
2160015
Address
2-16-1 Sugao Miyamaeku, Kawasaki
TEL
0449778111
Homepage URL
n2izawa@gmail.com
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine
Address
2-16-1 Sugao Miyamaeku, Kawasaki
Tel
0449778111
k-sienbu.mail@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
| 2019 | Year | 11 | Month | 13 | 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
| 2019 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
no special comments
Management information
Registered date
| 2019 | Year | 11 | Month | 13 | Day |
Last modified on
| 2021 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043948
