Establishment and Clinical Application of Precise SLNB System in Breast Cancer: a Randomized, Multicenter, Controlled Study
Clinical Study on Regularity of Lymphatic Drainage and Surgical Treatment of Breast Cancer
1 other identifier
interventional
500
1 country
1
Brief Summary
The investigatorsconduct the precise sentinel lymph node biopsy using preoperative computed tomographic lymphography in breast cancer. The investigators aimed to summarize the law of lymphatic drainage of breast, and to conduct the accurate surgical treatment of breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Jan 2016
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 26, 2019
CompletedFirst Posted
Study publicly available on registry
February 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedAugust 31, 2021
August 1, 2021
10 years
February 26, 2019
August 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Disease free survival
Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first, assessed up to 10 years.
Up to 10 years
Secondary Outcomes (1)
Overall survival
Up to 10 years
Study Arms (2)
SLNB and non-slns resection
EXPERIMENTAL1. Participants only receive SLNB 2. preoperative CT lymphography 3. SLNB with stained non-SLN resection 4. SLNB with ARM dissection
SLNB group
EXPERIMENTALParticipants only receive SLNB
Interventions
Participants only receive SLNB preoperative CT lymphography SLNB with stained non-SLN resection SLNB with ARM dissection
Eligibility Criteria
You may qualify if:
- histologically confirmed primary breast cancer by core needle biopsy or excisional biopsy
- abnormal para-sentinel lymph node was found by ultrasound examination
- ultrasound-guided fine needle aspiration cytology of these nodes were performed
- the result of fine needle aspiration cytology was negative (no tumour cell was found)
- participants planed to perform SLNB
You may not qualify if:
- pathological diagnosed ductal carcinoma in situ by excisional biopsy
- the result of fine needle aspiration cytology was positive
- participants has received neo-adjuvant system therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Qifeng Yang
Jinan, Shandong, 250012, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qifeng Yang
Qilu Hospital of Shandong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 26, 2019
First Posted
February 28, 2019
Study Start
January 1, 2016
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
August 31, 2021
Record last verified: 2021-08