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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034806
Receipt No. R000039688
Scientific Title Objective and subjective assessment of the lymphedema in breast cancer patients who underwent sentinel lymph node biopsy or axillary lymph node dissection.
Date of disclosure of the study information 2018/11/12
Last modified on 2019/05/09

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Basic information
Public title Objective and subjective assessment of the lymphedema in breast cancer patients who underwent sentinel lymph node biopsy or axillary lymph node dissection.
Acronym Objective and subjective assessment of the lymphedema in breast cancer patients who underwent sentinel lymph node biopsy or axillary lymph node dissection.
Scientific Title Objective and subjective assessment of the lymphedema in breast cancer patients who underwent sentinel lymph node biopsy or axillary lymph node dissection.
Scientific Title:Acronym Objective and subjective assessment of the lymphedema in breast cancer patients who underwent sentinel lymph node biopsy or axillary lymph node dissection.
Region
Japan

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

Objectives
Narrative objectives1 This study aims to reveal the frequency and severity of lymphedema after sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) based on patient-reported outcome (PRO) and objective assessment by medical staff.
Basic objectives2 Others
Basic objectives -Others Establishing the appropriate method to assess lymphedema after surgery
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The frequency of lymphedema after surgery based on subjective and objective assessment by surgical procedure
Key secondary outcomes 1. The correlation between subjective assessment (PRO-CTCAE JAPANESE ver1.0; "frequency", "severity", "interference") and objective assessment (the difference of upper arm diameter between right and left, the ratio of external cell water and total body water [ECW/TBW] with InBody770)
2. The difference of the lymphedema frequency by cut off point of objective assessment
3. The correlation between body mass index (BMI) and the lymphedema frequency based on subjective and objective assessment
4. The lymphedema frequency by postoperative year

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 - Age >20
- ECOG performance status of 0-2
- Written informed consent must be obtained from all participants before enrollment
Key exclusion criteria - Participants with recurrence
- Participants under adjuvant chemotherapy and radiotherapy
- Participants with history of bilateral SLNB or ALND
- Participants with upper arm paralysis for a reason other than lymphedema
- Participants with disease other than breast cancer, which possibly cause lymphedema
- Participants with systemic edema for some systemic disease such as renal failure and heart failure
- Participants who physician judges inadequate for this trial
- Participants with metal device such as pacemaker
- Participants with pregnancy or suspicious pregnancy
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Mitsuo
Middle name
Last name Terada
Organization Aichi Cancer Center
Division name Department of breast oncology
Zip code 464-8681
Address 1-1, Kanoko-den, Chikusa-ku, Nagoya, Aichi, JAPAN
TEL 052-762-6111
Email mterada@aichi-cc.jp

Public contact
Name of contact person
1st name Mitsuo
Middle name
Last name Terada
Organization Aichi Cancer Center
Division name Department of breast oncology
Zip code 464-8681
Address 1-1, Kanoko-den, Chikusa-ku, Nagoya, Aichi, JAPAN
TEL 052-762-6111
Homepage URL
Email mterada@aichi-cc.jp

Sponsor
Institute Aichi Cancer Center
Department of breast oncology
Institute
Department

Funding Source
Organization Self funding
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 Aichi Cancer Center
Address 1-1, Kanoko-den, Chikusa-ku, Nagoya, Aichi, JAPAN
Tel 052-762-6111
Email irb@aichi-cc.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 愛知県がんセンター

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 12 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 12 Day
Last follow-up date
2019 Year 01 Month 30 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational items: hight, body weight, upper arm diameter, body moisture by InBody, questioner including PRO-CTCAE

Management information
Registered date
2018 Year 11 Month 07 Day
Last modified on
2019 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039688

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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