UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037532 |
|---|---|
| Receipt number | R000042788 |
| Scientific Title | Research of diagnostic significance of lymph nodes micrometastasis by OSNA for pStage II colorectal cancer. |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2022/08/01 13:19:12 |
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Basic information
Public title
Research of diagnostic significance of lymph nodes micrometastasis by OSNA for pStage II colorectal cancer.
Acronym
Research of diagnostic significance of lymph nodes micrometastasis by OSNA for pStage II colorectal cancer.
Scientific Title
Research of diagnostic significance of lymph nodes micrometastasis by OSNA for pStage II colorectal cancer.
Scientific Title:Acronym
Research of diagnostic significance of lymph nodes micrometastasis by OSNA for pStage II colorectal cancer.
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To pick up high risk cases of Stage II colorectal cancer using lymph nodes metastasis detected by OSNA and to clarify the necessity of postoperative chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3 year recurrence free survival rate
Key secondary outcomes
5 year recurrence free survival rate
Association between clinicopathological factors and diagnosis of OSNA
Association with postoperative adjuvant chemotherapy
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
<OSNA installed facility>
Patients 20 years old or older
Patients diagnosed with cStage I-III colorectal cancer
Patients who is to carry out OSNA
Patients who have not offered a refuse to optout
<OSNA non-installed facility>
Patients 20 years old or older
Patients diagnosed with cStage I-III colorectal cancer
Lymph nodes collected at the time of surgery is cryopreserved and available
Patients who obtained written consent
Key exclusion criteria
<OSNA installed facility>
Patients who lack the ability to agree
Patients who receive neoadjuvant chemotherapy
Active double cancer (synchronous double cancer/Multiple cancer and metachronous double cancer/multiple cancer with disease-free survival of 5 years or less, but excluding carcinoma in situ that is judged to be cured by local treatment
Patients who died or relapsed within 60 days after the operation
Patients who is judged to be ineligible to participate in the study by the research principal doctor or co-investigator
<OSNA non-installed facility>
Patients who lack the ability to agree
Patients who receive neoadjuvant chemotherapy
Active double cancer (synchronous double cancer/Multiple cancer and metachronous double cancer/multiple cancer with disease-free survival of 5 years or less, but excluding carcinoma in situ that is judged to be cured by local treatment
Patients who died or relapsed within 60 days after the operation
Patients who is judged to be ineligible to participate in the study by the research principal doctor or co-investigator
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Nariaki |
| Middle name | |
| Last name | Matsuura |
Organization
Osaka International Cancer Institute
Division name
Gastroenterological surgery
Zip code
5418567
Address
3-1-69 Otemae, Chuoku, Osaka
TEL
0669451181
nmatsuura@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | Mamoru |
| Middle name | |
| Last name | Uemura |
Organization
Osaka University
Division name
Department of Gastroenterology
Zip code
5650871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
0668793251
Homepage URL
muemura@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka International Institute
Institute
Department
Personal name
Funding Source
Organization
BTC Research
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
Osaka University Clinical Research Review Committee
Address
2-2 Yamadaoka, Suita, Osaka
Tel
0662108289
rinri@hp-crc.med.osaka-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 | 08 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2026 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 07 | Month | 29 | Day |
Last modified on
| 2022 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042788
| 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 |
