UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022526 |
|---|---|
| Receipt number | 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 14:48:57 |
* 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
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
u-1ro@kcho.jp
Sponsor or person
Institute
Kobe Medical Center General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025684
