UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043176 |
|---|---|
| Receipt number | R000049283 |
| Scientific Title | Effect of different biopsy forceps diameters on pathological diagnosis of superficial cancer in head, neck and esophagus. |
| Date of disclosure of the study information | 2021/01/30 |
| Last modified on | 2024/02/01 19:14:30 |
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Basic information
Public title
Effect of different biopsy forceps diameters on pathological diagnosis of superficial cancer in head, neck and esophagus.
Acronym
Effect of different biopsy forceps diameters on pathological diagnosis of superficial cancer in head, neck and esophagus.
Scientific Title
Effect of different biopsy forceps diameters on pathological diagnosis of superficial cancer in head, neck and esophagus.
Scientific Title:Acronym
Effect of different biopsy forceps diameters on pathological diagnosis of superficial cancer in head, neck and esophagus.
Region
| Japan |
Condition
Condition
superficial cancer in head, neck and esophagus
Classification by specialty
| Gastroenterology | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of different biopsy forceps diameters on pathological diagnosis of superficial cancer in head, neck and esophagus.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The accuracy of pathological diagnosis by biopsy forceps when pathological diagnosis of endoscopically resected specimen is used as reference standard.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
A large biopsy forceps group
At the time of endoscopic treatment, one biopsy is performed from the lesion, using biopsy forceps with a minimum working channel of 2.8mm.
Interventions/Control_2
A small biopsy forceps group
At the time of endoscopic treatment, two biopsies are performed from the lesion, using biopsy forceps with a minimum working channel of 2.0mm.
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
squamous cell carcinoma, already diagnosed or suspected
More than 20 years old
In the case of superficial esophageal cancer, no history of chemotherapy, radiation therapy, or surgery for esophageal cancer
In the case of superficial head and neck cancer, no history of chemotherapy, radiation therapy, or surgery for head and neck cancer
More than 3 months since last chemotherapy for other carcinoma
Endoscopically diagnosed as 10mm or more
Localization without cervical part of esophagus
No organ failure
Key exclusion criteria
Patients with contraindications of iodine stain
Patients with hemorrhagic disorders, except for patients with coagulopathy or anticoagulant therapy who can follow the Japanese guideline.
Pregnancy
Disqualified patients with other reasons
Target sample size
435
Research contact person
Name of lead principal investigator
| 1st name | Ryu |
| Middle name | |
| Last name | Ishihara |
Organization
Osaka International Cancre Institute
Division name
Gastrointestinal Oncology
Zip code
541-8567
Address
3-1-69 Otemae Chuoku Osaka
TEL
06-6945-1181
isihara-ry@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Tani |
Organization
Osaka International Cancre Institute
Division name
Gastrointestinal Oncology
Zip code
541-8567
Address
3-1-69 Otemae Chuoku Osaka
TEL
06-6945-1181
Homepage URL
yasuhiro.tani@oici.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
Osaka International Cancer Institute
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka International Cancer Institute
Address
3-1-69 Otemae Chuoku Osaka
Tel
06-6945-1181
rinri01@opho.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 | 01 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 29 | Day |
Last modified on
| 2024 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049283
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| Registered date | File name |
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| Registered date | File name |
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