UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021307 |
|---|---|
| Receipt number | R000024568 |
| Scientific Title | Study on preoperative diagnosis of gastric type adenocarcinoma of the uterine cervix using Cica HIK gastric mucin Kit which detects gastric mucin in cervical mucus |
| Date of disclosure of the study information | 2016/03/07 |
| Last modified on | 2025/03/10 10:12:04 |
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Basic information
Public title
Study on preoperative diagnosis of gastric type adenocarcinoma of the uterine cervix using Cica HIK gastric mucin Kit which detects gastric mucin in cervical mucus
Acronym
Preoperative diagnosis of gastric type adenocarcinoma using gastric mucin
Scientific Title
Study on preoperative diagnosis of gastric type adenocarcinoma of the uterine cervix using Cica HIK gastric mucin Kit which detects gastric mucin in cervical mucus
Scientific Title:Acronym
Preoperative diagnosis of gastric type adenocarcinoma using gastric mucin
Region
| Japan |
Condition
Condition
adenocarcinoma of the uterine cervix, gastric type adenocarcinoma
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Gastric type adenocarcinoma of the uterine cervix is a subtype of cervical adenocarcinoma, characterized by the production of gastric mucin and poor prognosis. However, preoperative diagnosis of gastric type adenocarcinoma by routine cervical cytology and biopsy is difficult. This study is aim to examine the effectiveness of Cica HIK gastric mucin Kit with detects gastric mucin in cervical mucus on the preoperative diagnosis of gastric type adenocarcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
positive predictive value of the Kit
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Researchers examine the secretion of gastric mucin using Cica HIK gastric mucin Kit in cervical mucus of the patients with cervical adenocarcinoma who are planned to undergo operation.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Women who are already diagnosed with cervical adenocarcinoma by routine cervical cytology and biopsy
Key exclusion criteria
Nothing particular
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Kashima |
Organization
Shinshu University School of Medicine
Division name
Department of Obstetrics & Gynecology
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto 390-8621
TEL
0263-37-2719
hijksn@gmail.com
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Kashima |
Organization
Shinshu University School of Medicine
Division name
Department of Obstetrics & Gynecology
Zip code
390-8621
Address
3-1-1 Asahi Matsumoto, 390-8621
TEL
0263-37-2719
Homepage URL
hijksn@gmail.com
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-aid for Scientific Research from the Japan Society for the Promotion of Science
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
Shinshu University, School of Medicine, Department of Obstetrics and Gynecology.
Address
3-1-1, Asahi , Matsumoto, 390-8621
Tel
+81-263-37-2719
ifujin@shinshu-u.ac.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
| 2016 | Year | 03 | Month | 07 | Day |
Related information
URL releasing protocol
Study on the diagnostic potential of Cika HIK Kit for gastric-type adenocarcinoma of the uterine cer
Publication of results
Unpublished
Result
URL related to results and publications
Negative
Number of participants that the trial has enrolled
20
Results
Negative result. (Kit-positivity: 30%)
Results date posted
| 2025 | Year | 03 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Medical OB/GYN hospitals in Japan
Participant flow
Notification by mails
Adverse events
No
Outcome measures
Kit-positive ratio
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2016 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | 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
| 2016 | Year | 03 | Month | 03 | Day |
Last modified on
| 2025 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024568
