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

NCT06394050 | Not Yet Recruiting

• 1 other identifier: KY2020-060-01
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diagnosis

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance

  Area under curve, accuracy, sensitivity, specificity,

  Baseline

Study Arms (1)

Breast cancer patients after neoadjuvant treatment

Diagnostic Test: Diagnostic Test

Interventions

Diagnostic Test DIAGNOSTIC_TEST

there is no intervention

Breast cancer patients after neoadjuvant treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with local advanced breast cancer who had completed surgery after neoadjuvant therapy from Renji Hospital, School of Medicine, Shanghai Jiao Tong University.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• RenJi Hospital: lead

Related 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.

  PMID: 32094303 BACKGROUND

MeSH Terms

Conditions

Disease

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Breast Surgery

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: May 1, 2024
• Study Start: May 1, 2024
• Primary Completion: May 15, 2024
• Study Completion: May 20, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04