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NCT06394050 Clinical Trial

Label-free Raman Spectroscopy for Discrimination Between Breast Cancer Tumor and Adjacent Tissues After Neoadjuvant Treatment

Diagnosis Clinical Trial

Official title:
Utilizing Label-free Raman Spectroscopy for Discrimination Between Breast Cancer Tumor and Adjacent Tissues in Patients After Neoadjuvant Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06394050
Other study ID # KY2020-060-01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2024
Est. completion date May 20, 2024

Study information
Verified date April 2024
Source RenJi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

After neoadjuvant therapy, the primary lesion in breast cancer patients may experience tumor regression, which increases the difficulty of distinguishing between breast cancer and adjacent tissues. Raman spectroscopy is a form of scattering spectroscopy, which offers rapid and sensitive analysis, delivering detailed biochemical information and molecular signatures of internal molecular components within the sample. This study aims to discern between cancer and adjacent tissues after neoadjuvant therapy in breast cancer patients using label-free Raman spectroscopy.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date May 20, 2024
Est. primary completion date May 15, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - (1) aged = 18 years; (2) histologically confirmed invasive breast cancer (clinical tumor stage T1 to T4, nodal stage N1-3, and metastasis stage M0); (3) previous treatment with neoadjuvant chemotherapy with or without target therapy (such as trastuzumab, pertuzumab), or endocrine therapy; (4) enough frozen samples of breast cancer tumor and adjacent tissue. Exclusion Criteria: - (1) undergoing sentinel lymph node biopsy with indocyanine green dye or methylene blue injection after neoadjuvant therapy; (2) Breast cancer during pregnancy and lactation, inflammatory breast cancer.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Diagnostic Test
there is no intervention

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
RenJi Hospital

References & Publications (1)

Vanna R, Morasso C, Marcinno B, Piccotti F, Torti E, Altamura D, Albasini S, Agozzino M, Villani L, Sorrentino L, Bunk O, Leporati F, Giannini C, Corsi F. Raman Spectroscopy Reveals That Biochemical Composition of Breast Microcalcifications Correlates with Histopathologic Features. Cancer Res. 2020 Apr 15;80(8):1762-1772. doi: 10.1158/0008-5472.CAN-19-3204. Epub 2020 Feb 24. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic performance Area under curve, accuracy, sensitivity, specificity, Baseline
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