UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034806 |
|---|---|
| Receipt number | 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 | 2019/08/21 08:00:07 |
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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
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
mterada@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center
Department of breast oncology
Institute
Department
Personal name
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
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 26 | Day |
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 | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039688
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| Research case data | |
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