Sentinel Lymph NodeNCT07018505
EpCAM-Targeted Surface-Enhanced Raman Spectroscopy Nanotags for Rapid Evaluation of Surgical Margins and Sentinel Lymph Node Metastasis Status in Breast Cancers
An observational study of Sentinel Lymph Node and Breast Cancers, run by Yunnan Cancer Hospital at 1 site in China.
Trial summary
For early breast cancer patients, breast-conserving surgery and sentinel lymph node biopsy have emerged as the cornerstone of precision oncology, harmonizing oncologic efficacy with the preservation of breast cosmetics and axillary function. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Sentinel Lymph Node, Breast Cancers, Metastases
- What is being tested?
- SERS detection
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2025to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The investigators plan to enroll 40 female patients, aged 18 to 75 years, who have been assessed to have resectable breast cancer and are scheduled to undergo surgery. During the surgery, the resected cancers and lymph nodes will be collected for SERS detection, and Raman signals from the tissues will be collected.
Who may be able to join
- Adult patients between 18-75 years of age
- Female
- Patients presenting with a breast cancer to be resectable on pre-operative assessment
- Good operative candidate
- Subject capable of giving informed consent and participating in the process of consent
Who cannot join
- Patients unable to participate in the consent process
- Patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc
- Other conditions that the researcher considers inappropriate to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jing-Wen Bai, Doctor contact
China1 site
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
Guo-Jun Zhang, Doctor, +86 0871-68231187, zhangguojun@kmmu.edu.cn
Kang-Liang Lou, Doctor, 8615158661275, 15158661275@163.com
About this study
For early breast cancer patients, breast-conserving surgery and sentinel lymph node biopsy have emerged as the cornerstone of precision oncology, harmonizing oncologic efficacy with the preservation of breast cosmetics and axillary function. However, conventional margin evaluation relies on subjective experience, leading to positive margin rates of 15%-50% Additionally, sentinel lymph node biopsy faces inherent technical limitations, including prolonged procedural time and significant false-negative rates in detecting micro-metastases. To overcome these challenges, the investigators will introduce a stable "sandwich" EpCAM-targeted surface-enhanced Raman spectroscopy (SERS) detection system to provide rapid evaluation of surgical margins and sentinel lymph node (SLN) metastasis status. In brief, a portion of resected tissue will be immediately homogenized by grinding, and the tissue homogenate will then be analyzed using this detection system to determine its histological characteristics. Pathological confirmation will further validate the method. This approach aims to improve the accuracy and efficiency of intraoperative assessment of breast-conserving surgical margins and SLN status, thereby effectively reducing local recurrence rates and complications.
- Conditions
- Sentinel Lymph Node, Breast Cancers, Metastases, Margin Assessment
- Being tested
- SERS detection
- Keywords
- Sentinel Lymph Node, Surface Enhanced Raman Spectroscopy, EpCAM, Breast cancers, Surgical margin
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SERS detectionDiagnostic test
Incubation: A mixture of 20 μL (0.5 mg/mL) magnetic beads (MB@RB20115UD), 40 μL SERS nanotags (Au-IR808@RB20115UC), and prepared sample is incubated for 5 min.
Washing: The supernatant is removed after magnetic separation (30 s), followed by washing with PBST (pH 7.4, 0.05% Tween-20).
Detection: The separated pellet is resuspended in 10 μL ultrapure water. Then 2 μL solution is spotted onto a 2.5 mm × 2.5 mm gold substrate for air-drying. Raman spectra are acquired using a portable spectrometer (785 nm laser, 500 mW power, 5 s acquisition time, triplicate measurements). Peak areas within 540-570 cm-1 are quantified.
| Study group | Role | What they receive |
|---|---|---|
| Surface Enhanced Raman Spectroscopy (SERS) Detection | Intraoperatively, approximately 5 mm samples of tumor and adjacent normal tissues are collected from breast cancer patients after resection. After lymph nodes dissection, the tissues are bisected longitudinally along the maximum cross-section. The collected tissues are then divided into two portions. One portion is weighed, and tissue lysis buffer (RIPA:PIC:PMSF = 100:1:1) is added at a ratio of 5 μL per 1 mg tissue. The tissue is minced into 1 mm fragments on ice, and 3 mm zirconium beads are added for homogenization based on tissue weight. The homogenate is centrifuged at 12,000 g for 2 min at 4°C. The supernatant (50 μL) is collected for detection, and the remaining tissue is reserved for pathological evaluation. Receives: Diagnostic Test: SERS detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differentiation of breast cancer and para-cancer tissues as well as metastatic and normal lymph nodes
Raman intensity of breast cancer and para-cancer tissues as well as metastatic and normal lymph nodes after SERS detection.
Measured: 1 year
Secondary outcomes (2)
Expression of EpCAM in the breast cancer and metastatic lymph nodes
Raman intensity of the breast cancer tissues and metastatic lymph nodes with different EpCAM expression level after SERS detection.
Measured: 1 year
The Diagnostic Efficiency of SERS detection
The Area Under the Curve (AUC) of the Receiver Operating Characteristic (ROC), sensitivity and specificity of SERS detection for breast cancers and metastatic lymph nodes.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start15 Jun 2025 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sentinel Lymph NodeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunnan Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xiang'an Hospital of Xiamen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018505
- Sponsor's protocol ID
- KYLX2025-149
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guan PC, Zhang H, Li ZY, Xu SS, Sun M, Tian XM, Ma Z, Lin JS, Gu MM, Wen H, Zhang FL, Zhang YJ, Yu GJ, Yang C, Wang ZX, Song Y, Li JF. Rapid Point-of-Care Assay by SERS Detection of SARS-CoV-2 Virus and Its Variants. Anal Chem. 2022 Dec 27;94(51):17795-17802. doi: 10.1021/acs.analchem.2c03437. Epub 2022 Dec 13.
PubMed 36511436
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EpCAM-Targeted Surface-Enhanced Raman Spectroscopy Nanotags for Rapid Evaluation of Surgical Margins and Sentinel Lymph Node Metastasis Status in Breast Cancers
- ClinicalTrials.gov ID
- NCT07018505
- Acronym / sponsor ID
- KYLX2025-149
- Conditions
- Sentinel Lymph Node, Breast Cancers, Metastases, Margin Assessment
- Keywords
- Sentinel Lymph Node, Surface Enhanced Raman Spectroscopy, EpCAM, Breast cancers, Surgical margin
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yunnan Cancer HospitalUniversity, hospital or other
- Collaborators
- Xiang'an Hospital of Xiamen University
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For early breast cancer patients, breast-conserving surgery and sentinel lymph node biopsy have emerged as the cornerstone of precision oncology, harmonizing oncologic efficacy with the preservation of breast cosmetics and axillary function. However, conventional margin evaluation relies on subjective experience, leading to positive margin rates of 15%-50% Additionally, sentinel lymph node biopsy faces inherent technical limitations, including prolonged procedural time and significant false-negative rates in detecting micro-metastases. To overcome these challenges, the investigators will introduce a stable "sandwich" EpCAM-targeted surface-enhanced Raman spectroscopy (SERS) detection system to provide rapid evaluation of surgical margins and sentinel lymph node (SLN) metastasis status. In brief, a portion of resected tissue will be immediately homogenized by grinding, and the tissue homogenate will then be analyzed using this detection system to determine its histological characteristics. Pathological confirmation will further validate the method. This approach aims to improve the accuracy and efficiency of intraoperative assessment of breast-conserving surgical margins and SLN status, thereby effectively reducing local recurrence rates and complications.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surface Enhanced Raman Spectroscopy (SERS) Detection | – | Diagnostic Test: SERS detectionIntraoperatively, approximately 5 mm samples of tumor and adjacent normal tissues are collected from breast cancer patients after resection. After lymph nodes dissection, the tissues are bisected longitudinally along the maximum cross-section. The collected tissues are then divided into two portions. One portion is weighed, and tissue lysis buffer (RIPA:PIC:PMSF = 100:1:1) is added at a ratio of 5 μL per 1 mg tissue. The tissue is minced into 1 mm fragments on ice, and 3 mm zirconium beads are added for homogenization based on tissue weight. The homogenate is centrifuged at 12,000 g for 2 min at 4°C. The supernatant (50 μL) is collected for detection, and the remaining tissue is reserved for pathological evaluation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators plan to enroll 40 female patients, aged 18 to 75 years, who have been assessed to have resectable breast cancer and are scheduled to undergo surgery. During the surgery, the resected cancers and lymph nodes will be collected for SERS detection, and Raman signals from the tissues will be collected.
Key inclusion criteria (5 listed)
- Adult patients between 18-75 years of age
- Female
- Patients presenting with a breast cancer to be resectable on pre-operative assessment
- Good operative candidate
- Subject capable of giving informed consent and participating in the process of consent
Key exclusion criteria (3 listed)
- Patients unable to participate in the consent process
- Patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc
- Other conditions that the researcher considers inappropriate to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SERS detectionIncubation: A mixture of 20 μL (0.5 mg/mL) magnetic beads (MB@RB20115UD), 40 μL SERS nanotags (Au-IR808@RB20115UC), and prepared sample is incubated for 5 min. Washing: The supernatant is removed after magnetic separation (30 s), followed by washing with PBST (pH 7.4, 0.05% Tween-20). Detection: The separated pellet is resuspended in 10 μL ultrapure water. Then 2 μL solution is spotted onto a 2.5 mm × 2.5 mm gold substrate for air-drying. Raman spectra are acquired using a portable spectrometer (785 nm laser, 500 mW power, 5 s acquisition time, triplicate measurements). Peak areas within 540-570 cm-1 are quantified. | Diagnostic test | Surface Enhanced Raman Spectroscopy (SERS) Detection |
Primary outcome
Differentiation of breast cancer and para-cancer tissues as well as metastatic and normal lymph nodes
Time frame: 1 year
Raman intensity of breast cancer and para-cancer tissues as well as metastatic and normal lymph nodes after SERS detection.
2 secondary outcomes
Expression of EpCAM in the breast cancer and metastatic lymph nodes
Time frame: 1 year
The Diagnostic Efficiency of SERS detection
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Background: PubMed 36511436Guan PC, Zhang H, Li ZY, Xu SS, Sun M, Tian XM, Ma Z, Lin JS, Gu MM, Wen H, Zhang FL, Zhang YJ, Yu GJ, Yang C, Wang ZX, Song Y, Li JF. Rapid Point-of-Care Assay by SERS Detection of SARS-CoV-2 Virus and Its Variants. Anal Chem. 2022 Dec 27;94(51):17795-17802. doi: 10.1021/acs.analchem.2c03437. Epub 2022 Dec 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing-Wen Bai, Doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sentinel Lymph Node and Breast Cancers, run by Yunnan Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kang-Liang Lou, Doctor (+8615158661275, 15158661275@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differentiation of breast cancer and para-cancer tissues as well as metastatic and normal lymph nodes (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07018505, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.