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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043342
Receipt No. R000049488
Scientific Title Lymph node evaluation of new dissection techniques to assessment circumferential resection margin
Date of disclosure of the study information 2021/02/17
Last modified on 2021/02/16

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Basic information
Public title Lymph node evaluation of new dissection techniques to assessment circumferential resection margin
Acronym LEARN
Scientific Title Lymph node evaluation of new dissection techniques to assessment circumferential resection margin
Scientific Title:Acronym LEARN
Region
Japan

Condition
Condition rectal cancer
Classification by specialty
Surgery in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To observe whether sufficient lymph node search (12 or more) is performed by the new dissection techniques to assess circumferential resection margin
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Number of lymph node searches
Key secondary outcomes

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

Not applicable
Gender Male and Female
Key inclusion criteria Histologically diagnosed as adenocarcinoma in the 9th edition of the Colorectal Cancer Handling Regulations by preoperative endoscopic biopsy from the primary rectal lesion.
The main occupying site of the tumor is in the lower rectum, or the lower edge of the tumor is in the lower rectum.
One of the following surgical procedures is planned for rectal cancer.
Lower anterior resection (LAR), ultra-low anterior resection (SLAR), abdominal perineal rectal resection (APR), intersphincteric resection (ISR), Hartmann surgery to dissect below the peritoneal inversion, Total colectomy, total pelvic organ resection (TPE)
cStage II-III in TNM classification (UICC 8th edition)
No history of surgery, chemotherapy, or radiation therapy for primary diseases and pelvic tumors (rectal cancer, gynecological cancer, urological cancer, etc.)
Age 20 years or older at the time of enrollment in this study
Participants have received sufficient explanation about the research content and have agreed to the document.
Key exclusion criteria Anal canal cancer, anal fistula cancer
T4b (a tumor that directly invades other organs or tissues) with wall depth in UICC 8th edition
Patients judged by the attending physician to be inappropriate for research
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Manabu
Middle name
Last name Shiozawa
Organization Kanagawa Cancer Center
Division name Department of Gastrointestinal Surgery
Zip code 2418515
Address 2-3-2 Nakao, Asahi-Ku, Yokohama 241-8515, Japan.
TEL 0455202222
Email shiozawam@kcch.jp

Public contact
Name of contact person
1st name Suguru
Middle name
Last name Nukada
Organization Kanagawa Cancer Center
Division name Department of Gastrointestinal Surgery
Zip code 2418515
Address 2-3-2 Nakao, Asahi-Ku, Yokohama 241-8515, Japan.
TEL 0455202222
Homepage URL
Email s-nukada@kcch.jp

Sponsor
Institute Kanagawa Cancer Center
Institute
Department

Funding Source
Organization Kanagawa Cancer Center
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 Kanagawa Cancer Center
Address 2-3-2 Nakao, Asahi-Ku, Yokohama 241-8515, Japan.
Tel 0455202222
Email chiken-jimu4@kcch.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
2021 Year 02 Month 17 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
2021 Year 01 Month 12 Day
Date of IRB
2021 Year 02 Month 08 Day
Anticipated trial start date
2021 Year 02 Month 17 Day
Last follow-up date
2026 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To observe whether sufficient lymph node search (12 or more) is performed by the new dissection techniques to assess circumferential margin

Management information
Registered date
2021 Year 02 Month 16 Day
Last modified on
2021 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049488

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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