UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042009 |
|---|---|
| Receipt number | R000047366 |
| Scientific Title | A multicenter randomized controlled trial for evaluated the efficacy and safety of TDM-621 |
| Date of disclosure of the study information | 2020/10/05 |
| Last modified on | 2022/09/30 16:15:24 |
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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
skobayashi@3d-matrix.co.jp
Public contact
Name of contact person
| 1st name | satoru |
| Middle name | |
| Last name | kobayashi |
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
skobayashi@3d-matrix.co.jp
Sponsor or person
Institute
3-D Matrix, Ltd.
Institute
Department
Personal name
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
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
Published
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
| 2022 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047366
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
