UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048188 |
|---|---|
| Receipt number | R000054771 |
| Scientific Title | Association of breath and oral environment with bone metastases and skeletal related events of breast cancer |
| Date of disclosure of the study information | 2022/07/31 |
| Last modified on | 2023/01/06 13:52:45 |
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Basic information
Public title
Analysis of breath and oral environment of breast cancer patients
Acronym
Analysis of breath and oral environment of breast cancer patients
Scientific Title
Association of breath and oral environment with bone metastases and skeletal related events of breast cancer
Scientific Title:Acronym
Association of breath and oral environment with bone metastases and skeletal related events of breast cancer
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify relationship between breath metabolites and bone metastases, skeletal related events of breast cancer
Basic objectives2
Others
Basic objectives -Others
causal relationship
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
breath metabolites
Key secondary outcomes
Base
Study type
Observational
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
| Not applicable |
Gender
Female
Key inclusion criteria
(1) breast cancer
(2) stage I, II, III, IV
(3) subtype: luminal
(4) 20 years and older
(5) female
(6) patients who give informed consent before enrolling in the study
Key exclusion criteria
(1) male
(2) patients considered ineligible for enrolling the study by a doctor
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Tanda |
Organization
Tohoku University, graduate school of dentistry
Division name
Preventive dentistry
Zip code
980-8575
Address
Seiryo-machi 4-1, Aoba-ku, Sendai, 980-8575, Japan
TEL
81-22-717-8327
naoko.tanda.d5@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Tanda |
Organization
Tohoku University, graduate school of dentistry
Division name
Preventive dentistry
Zip code
980-8575
Address
Seiryo-machi 4-1, Aoba-ku, Sendai, 980-8575, Japan
TEL
81-22-717-8327
Homepage URL
naoko.tanda.d5@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Review Board at Tohoku University Graduate School of Dentistry
Address
Seiryo-machi 4-1, Aoba-ku, Sendai, 980-8575, Japan
Tel
81-22-718-0461
ec_den@rinri.hosp.tohoku.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
| 2022 | Year | 07 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To study relationship between breath metabolites and bone metastases, skeletal related events of breast cancer
Management information
Registered date
| 2022 | Year | 06 | Month | 29 | Day |
Last modified on
| 2023 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054771
