UMIN-CTR Clinical Trial

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
Email	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
Email	muemura@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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042788