UMIN-CTR Clinical Trial

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)
Email	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
Email	oyuko-t@umin.ac.jp

Sponsor
Institute	Graduate School of Medicine, The University of Tokyo
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016221