UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043342
Receipt number 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 2023/02/07 19:03:13

* 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

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@scchr.jp


Sponsor or person

Institute

Kanagawa Cancer Center

Institute

Department

Personal name



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

2028 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

2023 Year 02 Month 07 Day



Link to view the page

Value
https://center6.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