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出境医 / 临床实验 / Assessment of Breast Cancer-Related Arm Lymphedema
Assessment of Breast Cancer-Related Arm Lymphedema
Study Description
Brief Summary:
Breast cancer is a common malignant disease that threatens the health of women.As a serious chronic condition from breast cancer treatment, lymphedema, is caused by chronic accumulation of lymph fluid in the interstitial spaces of the affected limb or surrounding areas.Reported prevalence of lymphedema following treatment for breast cancer varies, ranging from 7-45% One reason for the wide variation in the reported incidence of lymphedema is the different measurement techniques used and the absence of an agreed diagnostic criteria. Nowadays, the common method include limb circumference measurement、limb volume measurement、bioimpedance spectroscopy (BIS) and self-report.Each of these methods has advantages and disadvantages . As a new method for detecting lymphedema ，some study have shown indocyanine green（ICG）lymphography can have a certain value for the detection of subclinical edema。Early detection demonstrate the greatest promise of reducing the incidence of late-stage lymphedema in breast cancer patients undergoing surgery.The aim of this study was therefore to examine the relationships between the most commonly used measures of lymphedema and the respective reliability of each of these tools. And if it's possible ,investigators are going to test which method is more sensitive for the diagnosis of clinical and subclinical lymphedema as well as the value of indocyanine green（ICG）in detecting sub-clinical lymphedema.
| Condition or disease | Intervention/treatment |
|---|---|
| Breast Neoplasms | Diagnostic Test: ICG、CM、VM、BIS、self-report |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Assessment of Breast Cancer-Related Arm Lymphedema-Comparison of Traditional Measurement Methods and Indocyanine Green（ICG）Lymphography |
| Estimated Study Start Date : | June 2019 |
| Estimated Primary Completion Date : | January 2022 |
| Estimated Study Completion Date : | January 2022 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
| patients with lymphedema |
Diagnostic Test: ICG、CM、VM、BIS、self-report
ways to examine lymphedema
Other Name: ICG =indocyanine green
|
Outcome Measures
Primary Outcome Measures :
- Sensitivity and specificity of indocyanine green (ICG) lymphography [ Time Frame: From date of enrollment until the date of first documented lymphedema, assessed up to 2 years. ]Sensitivity means the ability of detecting patients with true edema. Specificity means the ability of detecting non-edema patients.
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients who visit the clinic
Criteria
Inclusion Criteria:
- Patients with breast cancer who underwent axillary, axillary and other axillary surgery.
- Patients who have complaints about upper extremity edema and are willing to undergo examination.
- Sign the informed consent.
Exclusion Criteria:
- Bilateral breast cancer.
- A history of allergy to contrast agents.
- There are arteriovenous thrombosis in the affected limb.
- Regional lymph node recurrence
- Did not sign informed consent.
- Serious heart, brain and other diseases.
- The primary lymphatic system diseases (such as lymphatic leakage).
- Only one side of the limb received ICG angiography.
Contacts and Locations
Contacts
| Contact: liu siyao | +86 18801229921 | dr.liusiyao@pku.edu.cn |
Locations
| China, Beijing | |
| Peking University People's Hospital | Recruiting |
| Beijing, Beijing, China | |
| Contact: liu siyao +86 18801229921 doc_lsy@163.com | |
Sponsors and Collaborators
Peking University People's Hospital
Investigators
| Principal Investigator: | Wang Shu | Peking University People's Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | January 23, 2019 | ||||
| First Posted Date | June 7, 2019 | ||||
| Last Update Posted Date | June 11, 2019 | ||||
| Estimated Study Start Date | June 2019 | ||||
| Estimated Primary Completion Date | January 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Sensitivity and specificity of indocyanine green (ICG) lymphography [ Time Frame: From date of enrollment until the date of first documented lymphedema, assessed up to 2 years. ] Sensitivity means the ability of detecting patients with true edema. Specificity means the ability of detecting non-edema patients.
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Assessment of Breast Cancer-Related Arm Lymphedema | ||||
| Official Title | Assessment of Breast Cancer-Related Arm Lymphedema-Comparison of Traditional Measurement Methods and Indocyanine Green（ICG）Lymphography | ||||
| Brief Summary | Breast cancer is a common malignant disease that threatens the health of women.As a serious chronic condition from breast cancer treatment, lymphedema, is caused by chronic accumulation of lymph fluid in the interstitial spaces of the affected limb or surrounding areas.Reported prevalence of lymphedema following treatment for breast cancer varies, ranging from 7-45% One reason for the wide variation in the reported incidence of lymphedema is the different measurement techniques used and the absence of an agreed diagnostic criteria. Nowadays, the common method include limb circumference measurement、limb volume measurement、bioimpedance spectroscopy (BIS) and self-report.Each of these methods has advantages and disadvantages . As a new method for detecting lymphedema ，some study have shown indocyanine green（ICG）lymphography can have a certain value for the detection of subclinical edema。Early detection demonstrate the greatest promise of reducing the incidence of late-stage lymphedema in breast cancer patients undergoing surgery.The aim of this study was therefore to examine the relationships between the most commonly used measures of lymphedema and the respective reliability of each of these tools. And if it's possible ,investigators are going to test which method is more sensitive for the diagnosis of clinical and subclinical lymphedema as well as the value of indocyanine green（ICG）in detecting sub-clinical lymphedema. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients who visit the clinic | ||||
| Condition | Breast Neoplasms | ||||
| Intervention | Diagnostic Test: ICG、CM、VM、BIS、self-report
ways to examine lymphedema
Other Name: ICG =indocyanine green
|
||||
| Study Groups/Cohorts | patients with lymphedema
Intervention: Diagnostic Test: ICG、CM、VM、BIS、self-report
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
300 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | January 2022 | ||||
| Estimated Primary Completion Date | January 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03978754 | ||||
| Other Study ID Numbers | PUPH18050101 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Peking University People's Hospital | ||||
| Study Sponsor | Peking University People's Hospital | ||||
| Collaborators | Not Provided | ||||
| Investigators |
|
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| PRS Account | Peking University People's Hospital | ||||
| Verification Date | June 2019 | ||||
