UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037532
Receipt No. 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 2019/07/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 and 79 years old or younger
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 and 79 years old or younger
Patients who was diagnosed with Stage II colorectal cancer and was curatively resected
Patients who do not receive postoperative adjuvant chemotherapy
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 and metachronous double 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 and metachronous double 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
Email nmatsuura@mc.pref.osaka.jp

Public contact
Name of contact person
1st name Tsunekazu
Middle name
Last name MIzushima
Organization Osaka University
Division name Department of Gastroenterology, inflammatory bowel disease therapeutics
Zip code 5650871
Address 2-2 Yamadaoka, Suita, Osaka
TEL 0668793251
Homepage URL
Email tmizushima@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Osaka International Institute
Institute
Department

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
Email 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
2021 Year 06 Month 30 Day
Date of closure to data entry
2023 Year 12 Month 31 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
2019 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042788

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.