UMIN-CTR Clinical Trial

Basic information
Public title	TDM-621 clinical trial
Acronym	TDM-621 clinical trial
Scientific Title	A multicenter randomized controlled trial for evaluated the efficacy and safety of TDM-621
Scientific Title:Acronym	TDM-621 clinical trial
Region	Japan

Condition
Condition	Patients undergoing ESD for neoplasia of the stomach and rectum
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	evaluated the efficacy and safety of TDM-621 during ESD
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the number of coagulation by hemostatic forceps required to achieve intraprocedural haemostasis in TDM-621 versus control groups.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	TDM-621
Interventions/Control_2	Control(Hemostatic forceps)
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	Subjects who met all of the following items at the time of registration were included in this clinical trial. (1) An epithelial tumor with a maximum diameter of 3 cm to 6 cm (which is a single lesion) that is expected to be resected specimen for which ESD of the stomach (upper, middle) or rectum (upper, lower) is indicated Patients with (Based on the guidelines for gastric cancer/colon cancer treatment and stomach/colon ESD/EMR guidelines) Stomach: A differentiated cancer that is macroscopically diagnosed as intramucosal cancer (T1a) and is UL (-). Rectum: Preoperatively diagnosed with adenoma, intramucosal cancer, or mild invasive cancer in the submucosa (2) Patients aged 20 years or older at the time of obtaining consent (3) Patients who understand the content of the consent explanation document and can freely consent to the document (4) Patients who can visit the hospital and can be examined on a designated examination date such as examination schedule (5) Patients who are hospitalized or will be hospitalized
Key exclusion criteria	Subjects who met any of the following items at the time of enrollment were excluded from this trial. (1) Patients with local residual recurrence (2) Patients with ulcer in the target lesion (3) Poorly differentiated adenocarcinoma or undifferentiated cancer gastric cancer patients and rectal cancer patients (4) Patients with inflammatory bowel disease including ulcerative colitis (5) Patients with a history of hypersensitivity to peptide or protein products (6) Patients with Grade 2 or higher of Performance status according to the clinical evaluation criteria of cancer chemotherapy (7) Patients with serious liver disease, renal disease, cardiovascular disease, etc. [Assessment of severity of adverse event grade 3 or more in the Common Terminology Criteria for Adverse Events] (8) Patients with a condition in which reticuloendothelial system activity may be decreased such as disseminated intravascular coagulation (9) Patients who are receiving blood coagulation drugs (coagulation promoter = hemocoagulase, etc.), antifibrinolytic drugs (drugs having antifibrinolytic action = tranexamic acid, aprotinin preparation, etc.). However, regardless of the use of antiplatelet drugs, the drug should be discontinued in accordance with the guideline for gastrointestinal endoscopy for patients taking antithrombotic drugs. (10) Patients who are scheduled to undergo heparin replacement for ESD
Target sample size	170

Research contact person
Name of lead principal investigator	1st name satoru Middle name Last name kobayashi
Organization	3-D Matrix, Ltd.
Division name	Business Development
Zip code	1020083
Address	kojimachi-HF Building 7F 3-2-4, chiyoda-ku, Tokyo, Japan
TEL	0335113440
Email	skobayashi@3d-matrix.co.jp

Public contact
Name of contact person	1st name Yoshitaka Middle name Last name Kanemitsu
Organization	3D-Matrix, Ltd
Division name	Business Development
Zip code	1020083
Address	kojimachi-HF Building 7F 3-2-4, chiyoda-ku, Tokyo, Japan
TEL	0335113440
Homepage URL
Email	kanemitsu@3d-matrix.co.jp

Sponsor
Institute	3-D Matrix, Ltd.
Institute
Department

Funding Source
Organization	3-D Matrix, Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	TDM-621 clinical trial IRB
Address	kojimachi-HF Building 7F 3-2-4, chiyoda-ku, Tokyo, Japan
Tel	03-3511-3440
Email	skobayashi@3d-matrix.co.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	2020 Year 10 Month 05 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	227
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	under reviewing
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	Completed
Date of protocol fixation	2017 Year 05 Month 11 Day
Date of IRB	2017 Year 06 Month 19 Day
Anticipated trial start date	2017 Year 08 Month 03 Day
Last follow-up date	2019 Year 08 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 10 Month 05 Day
Last modified on	2020 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047366

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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