UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004298 |
|---|---|
| Receipt number | R000005153 |
| Scientific Title | Developing molecular markers to select the anti-cancer therapies in metastatic colorectal cancer |
| Date of disclosure of the study information | 2010/09/30 |
| Last modified on | 2010/09/30 00:27:13 |
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Basic information
Public title
Developing molecular markers to select the anti-cancer therapies in metastatic colorectal cancer
Acronym
Molecular markers to select the anti-cancer therapies in metastatic colorectal cancer
Scientific Title
Developing molecular markers to select the anti-cancer therapies in metastatic colorectal cancer
Scientific Title:Acronym
Molecular markers to select the anti-cancer therapies in metastatic colorectal cancer
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Retrospective study for analyzing the association between efficacy to anti-cancer drug therapies and various genetic alterations in metastatic colorectal cancer.
Basic objectives2
Others
Basic objectives -Others
Retrospective study for analyzing the association between efficacy to chemotherapy, molecular targeting therapies and genetic alterations of EGFR related signaling factors in metastatic colorectal cancer.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between the response rate of anti-cancer drug therapies and genetic alterations
Key secondary outcomes
Association between the prograssion free survival of anti-cancer drug therapies and genetic alterations
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Gene |
Interventions/Control_1
Oxialiplatin-based therapies (FOLFOX, CapeOX), Irinotecan-based therapies (FOLFIRI, IFL, IRIS), Molecular targeting therapies (Bevacizumab, Cetuximab)
Interventions/Control_2
Mutational analyses of various genes
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. Histologicaly defined colorectal cancer
2. Patients who have recieved second or subcequent lines of treatments.
3. Patients with a target resion.
4. ECOG performance status 0, 1 or 2
Key exclusion criteria
1. Patients without informed consent.
2. Formalin-fixed, paraffin-embedded (FFPE) samples of tumor tissue are not available
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chikashi Ishioka |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Department of Clinical Oncology
Zip code
Address
4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
TEL
022-717-8547
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Shimodaira |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Department of Clinical Oncology
Zip code
Address
4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
TEL
022-717-8547
Homepage URL
http://www.co.idac.tohoku.ac.jp/
hshimoda@idac.tohoku.ac.jp
Sponsor or person
Institute
Department of Clinical Oncology, Institute of Development, Aging and Cancer, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Department of Clinical Oncology, Institute of Development, Aging and Cancer, Tohoku University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Sendai Medical Center
Name of secondary funder(s)
South Miyagi Medical Center
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
東北大学加齢医学研究所、東北大学病院、仙台医療センター、みやぎ県南中核病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 30 | 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
| 2005 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 12 | 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
Management information
Registered date
| 2010 | Year | 09 | Month | 30 | Day |
Last modified on
| 2010 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005153
| Research Plan | |
|---|---|
| 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 |
