UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034923 |
|---|---|
| Receipt number | R000039826 |
| Scientific Title | Detection of acquired resistance to anti-EGFR monoclonal antibodies in patients with metastatic colorectal cancer using circulating tumor DNA |
| Date of disclosure of the study information | 2018/11/20 |
| Last modified on | 2018/11/18 13:55:34 |
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Basic information
Public title
Detection of acquired resistance to anti-EGFR monoclonal antibodies in patients with metastatic colorectal cancer using circulating tumor DNA
Acronym
Circulating tumor DNA in RAS-wildtype colorectal cancer
Scientific Title
Detection of acquired resistance to anti-EGFR monoclonal antibodies in patients with metastatic colorectal cancer using circulating tumor DNA
Scientific Title:Acronym
Circulating tumor DNA in RAS-wildtype colorectal cancer
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To assess the clinical usefulness of circulating tumor DNA by detecting acquired genetic changes of circulating tumor DNA during the treatment with anti-EGFR antibodies in patients with RAS-wildtype metastatic colorectal cancer.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between progression-free survival and the period from the introduction of anti-EGFR antibodies to detect genetic changes in circulating tumor DNA
Key secondary outcomes
Response rate, progression-free survival, overall survival, and concordance of genetic alterations between circulating tumor DNA and archival tissue
Association between progression-free survival and initial amount of circulating tumor DNA
Association between progression-free survival and changes in circulating tumor DNA amount 4 months after introduction of anti-EGFR antibodies
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
Patients with RAS-wildtype metastatic colorectal cancer who have a plan for administration of anti-EGFR antibody (performance status 0-2)
Key exclusion criteria
1. Patients diagnosed as double primary cancer
2. Patients with hereditary cancer syndrome
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Sawada |
Organization
Kanazawa University Graduate School of Medicine
Division name
Department of Cardiovascular and Internal Medicine
Zip code
Address
13-1 Takaramachi Kanazawa, 920-8641
TEL
076-265-2255
tsawada@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Yamada |
Organization
Kanazawa University Graduate School of Medicine
Division name
Department of Advanced Research in Community Medicine
Zip code
Address
13-1 Takaramachi Kanazawa
TEL
076-265-2255
Homepage URL
2nai5ken@gmail.com
Sponsor or person
Institute
Kanazawa University Graduate School of Medicine,
Department of Cardiovascular and Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Scientific Research Aid Division, Research Promotion Bureau, MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
金沢大学附属病院（石川県）、名古屋市立大学病院（愛知県）、埼玉県立がんセンター（埼玉県）、石川県立中央病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 20 | 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
| 2017 | Year | 06 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood samples will be obtained prior to the chemotherapy, 4 months and 10 months from the introduction of chemotherapy, thereafter, every 10 months until the progression of disease (PD).
Management information
Registered date
| 2018 | Year | 11 | Month | 18 | Day |
Last modified on
| 2018 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039826
