UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052601 |
|---|---|
| Receipt number | R000060027 |
| Scientific Title | An exploratory study of physical stress assessment during uterus cervical endoscopy and colposcopy |
| Date of disclosure of the study information | 2023/10/27 |
| Last modified on | 2024/04/24 09:07:14 |
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Basic information
Public title
An exploratory study of physical stress assessment during uterus cervical endoscopy and colposcopy
Acronym
Physical stress assessment during uterus cervical endoscopy and colposcopy
Scientific Title
An exploratory study of physical stress assessment during uterus cervical endoscopy and colposcopy
Scientific Title:Acronym
Physical stress assessment during uterus cervical endoscopy and colposcopy
Region
| Japan |
Condition
Condition
Patients with abnormal cervical cytology, Cervical dysplasia
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Explore the validity of salivary cortisol, amylase, and sIgA as objective indicators of physical stress in UCE and colposcopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary cortisol, amylase levels, and sIgA immediately before, immediately after, and 20 minutes after examination
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
Aged between 20 and 65 years old
Have given written consent to participate in this clinical research
Key exclusion criteria
Patients who have undergone cervical cancer surgery
Patients with psychosis or psychiatric symptoms that make it difficult to conduct this clinical trial.
Pregnant or of childbearing potential
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | KUNIHISA |
| Middle name | |
| Last name | UCHITA |
Organization
Kochi redcross hospital
Division name
depertment of gastroenterology
Zip code
780-8562
Address
Hataminamimachi Kochi city Japan
TEL
0888221201
ucchy31@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kunihisa |
| Middle name | |
| Last name | Uchita |
Organization
Kochi redcross hospital
Division name
depertment of gastroenterology
Zip code
780-8562
Address
Hataminamimachi Kochi city Japan
TEL
0888221201
Homepage URL
ucchy31@yahoo.co.jp
Sponsor or person
Institute
Kochi redcross hospital
Institute
Department
Personal name
Funding Source
Organization
Self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagawa univercity
Address
1750-1 Ikedo Miki town Kida gun Kagawa Japan
Tel
0878985111
md-chiken@kagawa-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
| 2023 | Year | 10 | Month | 27 | 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
| 2023 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
UCE is performed using testing methods approved by each facility, and saliva is collected before and after the test. Specifically, saliva is collected before changing into the examination gown and beginning the examination. Saliva is collected immediately after the test is completed. Saliva is collected approximately 20 minutes after the test. For colpo examination, saliva is collected while waiting for examination and before changing (before acetic acid processing). The examination is performed according to the same procedures as in each facility's usual practice. Saliva is collected immediately after the test is completed, and another 20 minutes later (note the time of collection). Both will be completed at the end of the session by having the patient fill out a prescribed questionnaire at the end of the session. These timings will be increased or decreased based on the data from each of the several cases.
Management information
Registered date
| 2023 | Year | 10 | Month | 24 | Day |
Last modified on
| 2024 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060027
