Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer

NCT04021069 | Unknown

• 1 other identifier: 270-2018
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines retrospective clinical data on patients diagnosed with breast cancer and monitor their response to neoadjuvant chemotherapy, incidence of locoregional recurrence, distant metastasis, and disease-free survival. The hypothesis of this study is that breast cancer patients who achieve a pathological complete response (pCR) to neoadjuvant chemotherapy demonstrate distinct clinicopathomic biomarker signatures.

Conditions

Breast Cancer; Invasive Ductal Breast Carcinoma; Invasive Lobular Breast Carcinoma

Keywords

radiomics; pathomics; breast cancer; machine learning; biomarkers

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response (pCR)

  Evaluating the degree of absence of residual cancer cells

  Up to 60 months

Secondary Outcomes (3)

• Time to local breast recurrence

  Up to 60 months

• Time to distant metastasis (months)

  Up to 60 months

• Time to death

  Up to 60 months

Interventions

Radiomic, pathomic, and clinical markers DIAGNOSTIC_TEST

This is a non-interventional study.

Eligibility Criteria

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

Study Population

This study will enroll women and men with a pathologically-confirmed diagnosis of invasive breast cancer of any stage, according to the AJCC v7 criteria.

You may qualify if:

• Participants must be men and women age 18+
• Biopsy-confirmed diagnosis of invasive breast cancer; (ER+/-, PR+/-, HER2+/-)
• Any state of disease as described by AJCC v7 criteria
• Participants must have received and completed neoadjuvant chemotherapy

You may not qualify if:

• Participants who had other primary cancers prior to breast cancer

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fixed tissue samples

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Ductal, Breast; Carcinoma, Lobular

Interventions

Radiomics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• William T. Tran, MRT(T), PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Kasia Jerzak, M.Sc., MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Fang-I Lu, MD, FRCPC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Therapist Clinician Scientist

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 16, 2019
• Study Start: August 30, 2018
• Primary Completion: December 30, 2019
• Study Completion: August 30, 2024
• Last Updated: July 16, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available within 12 months of study completion.
• Access Criteria: Digital pathology images, anonymized clinical data, source codes, and computational methods will be deposited to open-source repositories.

Locations

CA (1)