UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022526
Receipt No. R000025684
Scientific Title Survey of prevalence of hypothyroidism among breast cancer patients treated with radiation to supraclavicular field
Date of disclosure of the study information 2016/06/01
Last modified on 2017/05/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Survey of prevalence of hypothyroidism among breast cancer patients treated with radiation to supraclavicular field
Acronym Survey of RIHT among breast cancer patients
Scientific Title Survey of prevalence of hypothyroidism among breast cancer patients treated with radiation to supraclavicular field
Scientific Title:Acronym 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
1st name
Middle name
Last name Yuichiro Kikawa
Organization Kobe Medical Center General Hospital
Division name Department of Breast Surgery
Zip code
Address 2-2-1, Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo,Japan
TEL 0783024321
Email u-1ro@kcho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuichiro Kikawa
Organization Kobe Medical Center General Hospital
Division name Department of Breast Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://esmoopen.bmj.com/content/2/1/e000161
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 Completed
Date of protocol fixation
2016 Year 06 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.