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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000042009 |
Receipt No. | 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 | 2020/10/05 |
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
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Scientific Title:Acronym | TDM-621 clinical trial | |
Region |
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Condition | ||
Condition | Patients undergoing ESD for neoplasia of the stomach and rectum
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Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 170 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |||||||
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 |
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 |
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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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |