UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014114 |
|---|---|
| Receipt number | R000016221 |
| Scientific Title | Examination of the blood biomarker in examination testees, breast cancer patients and thyroid cancer patients |
| Date of disclosure of the study information | 2014/05/30 |
| Last modified on | 2022/12/05 16:01:07 |
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Basic information
Public title
Examination of the blood biomarker in examination testees, breast cancer patients and thyroid cancer patients
Acronym
Examination of the blood biomarker in examination testees, breast cancer patients and thyroid cancer patients
Scientific Title
Examination of the blood biomarker in examination testees, breast cancer patients and thyroid cancer patients
Scientific Title:Acronym
Examination of the blood biomarker in examination testees, breast cancer patients and thyroid cancer patients
Region
| Japan |
Condition
Condition
Breast cancer
Thyroid cancer
Classification by specialty
| Endocrine surgery | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Trefoil Factor Family (TFF) is increased in the serum in the patients with gastric cancer and pancreatic cancer. TFF will increase also in the serum of breast cancer and thyroid cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
The concentration of serum TFF of breast cancer and thyroid cancer patients.
The concentration of serum TFF ofexaminees.
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
Male and Female
Key inclusion criteria
Examinees
Patients with breast cancer
Patients with thyroid cancer
Key exclusion criteria
Creatinine abnormally high patient
Patients who had cancer in the past, or have cancer at the present
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Sachiyo |
| Middle name | |
| Last name | Nomura |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastrointestinal Surgery
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-3815-5411(ext.35144)
snomura-gi@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Ishibashi |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Metabolism Nutrition Endocrine Surgery
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-3815-5411(ext.35144)
Homepage URL
oyuko-t@umin.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Sachiyo Nomura research funding
Breast Endocrine Surgery research funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Dokkyo Medical University Koshigaya Hospital
International University of Health and Welfare Mita Hospital
Tsushima Ruriko female life clinic Ginza
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Medicine, The University of Tokyo, Ethics committee
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5841-0818
ethics@m.u-tokyo.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
東京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 30 | Day |
Related information
URL releasing protocol
https://www.nature.com/articles/s41598-017-05129-y
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-017-05129-y
Number of participants that the trial has enrolled
178
Results
Serum TFF1 and TFF3 levels in breast cancer patients were significantly higher than in healthy individuals. The serum TFF2 level in breast cancer patients was significantly lower than in healthy individuals.
High serum TFF1 and TFF3, and low TFF2 can be used for more refining of breast cancer patients for the imaging examination.
Results date posted
| 2022 | Year | 12 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
For the test set, serum from 94 breast cancer patients before treatment was taken. Among them, 59 patients were treated in the University of Tokyo Hospital, 22 patients were treated in the International University of Health and Welfare Mita Hospital, and 13 patients were treated in the Breast Center, Dokkyo Medical University Koshigaya Hospital, from May 2014 to June 2015. All the patients were female and their ages ranged from 32 to 88 years (average age: 56).
As healthy individuals, serum was taken from 84 female subjects, who received health checks in the NTT East Japan Kanto Hospital from July 2009 to January 2011. They had no history of malignancy previously or at the time of the health check. Their ages ranged from 26 to 82 years (average: 52).
Participant flow
serum from 94 breast cancer patients before and after treatment was taken.
As healthy individuals, serum was taken from 84 female subjects, who received health checks.
Adverse events
Not applicable
Outcome measures
Serum TFF1, TFF2, and TFF3 in breast cancer patients and healthy individuals.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 04 | Month | 30 | Day |
Other
Other related information
Trefoil Factor Family (TFF) is increased in the serum in the patients with gastric cancer and pancreatic cancer. TFF will increase also in the serum of breast cancer and thyroid cancer patients.
Prospective study
Management information
Registered date
| 2014 | Year | 05 | Month | 30 | Day |
Last modified on
| 2022 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016221
