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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000034035 |
Receipt No. | R000038799 |
Scientific Title | Pilot study of the usefulness of ALA for pimary colorectal cancer |
Date of disclosure of the study information | 2018/09/05 |
Last modified on | 2020/03/07 |
Basic information | ||
Public title | Pilot study of the usefulness of ALA for pimary colorectal cancer | |
Acronym | ALA | |
Scientific Title | Pilot study of the usefulness of ALA for pimary colorectal cancer | |
Scientific Title:Acronym | ALA | |
Region |
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Condition | ||
Condition | Colorectal cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Search for identifiability and safety of tumors using ALA |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Identification ratio |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Administration of ALA | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Histologically proved to be colorectal cancer | |||
Key exclusion criteria | Allergy for Porphyrin | |||
Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National cancer center hospital | ||||||
Division name | Division of Colorectal Surgery | ||||||
Zip code | 104-0045 | ||||||
Address | 5-1-1 Tsukiji, Chuo-ku, Tokyo | ||||||
TEL | 0335475201 | ||||||
ykanemit@ncc.go.jp |
Public contact | |||||||
Name of contact person |
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Organization | National Cancer Center Hospital | ||||||
Division name | Division of Colorectal Surgery | ||||||
Zip code | 104-0045 | ||||||
Address | 5-1-1 Tsukiji, Chuo-ku, Tokyo | ||||||
TEL | 0335475201 | ||||||
Homepage URL | |||||||
shtsukam@ncc.go.jp |
Sponsor | |
Institute | National Cancer Center |
Institute | |
Department |
Funding Source | |
Organization | National Cancer Center Hospital |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | National cancer center |
Address | 5-1-1 Tsukiji, Chuo-ku, Tokyo |
Tel | 0335475201 |
shtsukam@ncc.go.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 |
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Related information | |
URL releasing protocol | none |
Publication of results | Unpublished |
Result | |||||||
URL related to results and publications | none | ||||||
Number of participants that the trial has enrolled | 9 | ||||||
Results | The tumor identification rate by ALA was found to be only 4 out of 9 cases, and it was found to be less than half in 10 cases, violating the discontinuation criteria. The usefulness of ALA in colorectal cancer was not clear. | ||||||
Results date posted |
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Results Delayed | |||||||
Results Delay Reason | |||||||
Date of the first journal publication of results | |||||||
Baseline Characteristics | Colorectal cancer | ||||||
Participant flow | Preoperative registration | ||||||
Adverse events | none | ||||||
Outcome measures | Inactive cancellation | ||||||
Plan to share IPD | |||||||
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038799 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |