UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Survey of prevalence of hypothyroidism among breast cancer patients treated with radiation to supraclavicular field
Title of the study (Brief title)	Survey of RIHT among breast cancer patients
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the prevalence of hypothyroidism in breast cancer patients who received with a radiation therapy to supraclavicular field
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	proportion of hypothyroidism
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients with histologically confirmed breast cancer. 2)Patients who received radiation therapy to unilateral supraclavicular field between April 2007 and May 2016. 3)Patients who agreed to take blood sample. 4)Written informed consent, with the understanding that the patient may withdraw consent at any time without prejudice.
Key exclusion criteria	1)Patients who received radiation therapy to bilateral supraclavicular field. 2)Patients with thyroid disease before receiving radiation therapy. 3)Patients considered to be inappropriate for the study participation, as judged by the primary physician.
Target sample size	50

Research contact person
Name of lead principal investigator	Yuichiro Kikawa
Organization	Kobe Medical Center General Hospital
Division name	Department of Breast Surgery
Address	2-2-1, Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo,Japan
TEL	0783024321
Email	u-1ro@kcho.jp

Public contact
Name of contact person	Yuichiro Kikawa
Organization	Kobe Medical Center General Hospital
Division name	Department of Breast Surgery
Address	Chuoku
TEL	0783024321
Homepage URL
Email	u-1ro@kcho.jp

Sponsor
Institute	Kobe Medical Center General Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 01 Day
Anticipated trial start date	2016 Year 06 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2016 Year 08 Month 13 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://esmoopen.bmj.com/content/2/1/e000161
Results
Other related information	Between April 2007 and May 2016, patients with invasive breast cancer who received supraclavicular radiation in Kobe medical center general hospital were recruited

Management information
Registered date	2016 Year 05 Month 30 Day
Last modified on	2017 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025684