UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013720 |
|---|---|
| Receipt number | R000016014 |
| Scientific Title | Investigational Research of Biomarkers for Anti-EGFR Monoclonal Antibodies by Next Generation Sequencing |
| Date of disclosure of the study information | 2014/04/15 |
| Last modified on | 2020/08/19 17:41:34 |
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Basic information
Public title
Investigational Research of Biomarkers for Anti-EGFR Monoclonal Antibodies by Next Generation Sequencing
Acronym
Investigational Research of Biomarkers for Anti-EGFR Monoclonal Antibodies by Next Generation Sequencing
Scientific Title
Investigational Research of Biomarkers for Anti-EGFR Monoclonal Antibodies by Next Generation Sequencing
Scientific Title:Acronym
Investigational Research of Biomarkers for Anti-EGFR Monoclonal Antibodies by Next Generation Sequencing
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Medicine in general | Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate predicting biomarker for anti-EGFR(Epidermal Grouwth Factor Receptor) antibody
Basic objectives2
Others
Basic objectives -Others
Incidence and location of gene mutation corresponding to response to anti-EGFR antibody
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence and location of gene mutation corresponding to response to anti-EGFR antibody
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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)Patient with histologically confirmed primary adenocarcinoma.
2)Patient with advanced or recurrent colorectal carcinoma.
3)Patient with KRAS exon2 codon12/13 wild colorectal cancer.
4)Patient with lesion confirmed by imaging tests before chemotherapy.
5)Patient with metastatic colorectal cancer with measurable lesion according to RECIST ver.1.1
6)Patients who plan to receive chemotherapy including anti-EGFR antibody.
7)Patients who plan to receive imaging tests within 3 months after commencement of chemotherapy.
8)Age over 20.
9)Patient with metastatic colorectal cancer whose paraffin-embedded samples were obtained enough at St Marianna University School of Medicine Hospital .
10) Patient with written informed consent.
11) Patient who can provide bloody specimens before chemotherapy.
Key exclusion criteria
1) Patient with simultaneous or metachronous double cancers except carcinoma in situ or intramucosal tumor.
2) Patient with active bacterial or fungous infection.
3) Patient with uncontrollable pleural effusion or ascites.
4) Patient with history of interstitial neumonitis to pulmonary fibrosis.
5) Other patients who were considered by the primary care physician to be inappropriate as subjects of this trial.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takuro |
| Middle name | |
| Last name | Mizukami |
Organization
St. Marianna University School of Medicine
Division name
Department of clinical oncology
Zip code
2168511
Address
2-16-1,Sugao,Miyamae-ku,Kawasaki Kanagawa
TEL
0449778111
t3mizukami@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuro |
| Middle name | |
| Last name | Mizukami |
Organization
St. Marianna University School of Medicine
Division name
Department of clinical oncology
Zip code
2168511
Address
2-16-1,Sugao,Miyamae-ku,Kawasaki Kanagawa
TEL
0449778111
Homepage URL
t3mizukami@marianna-u.ac.jp
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
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kinki University School of Medicine, Department of Genome Biology
Name of secondary funder(s)
Kinki University School of Medicine, Department of Genome Biology
IRB Contact (For public release)
Organization
St Marianna University School of Medicine
Address
2-16-1,Sugao,Miyamae-ku,Kawasaki Kanagawa
Tel
044-977-8111
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
聖マリアンナ医科大学病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 15 | 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
40
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
| 2014 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analysis of incidence and location of gene mutation corresponding to response to anti-EGFR antibody
Management information
Registered date
| 2014 | Year | 04 | Month | 15 | Day |
Last modified on
| 2020 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016014
