Using Clinicopathomic Markers to Predict Neoadjuvant Chem... | NCT04021069

Studies
Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer

NCT04021069

Sponsor

Sunnybrook Health Sciences Centre

Status

Unknown status

Last Update Posted

Jul 16, 2019Actual

Enrollment

800Actual

Phase

Not provided

Conditions

Breast Cancer
Invasive Ductal Breast Carcinoma
Invasive Lobular Breast Carcinoma

Interventions

Radiomic, pathomic, and clinical markers

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 30, 2018Actual

Primary Completion Date

Dec 30, 2019Estimated

Completion Date

Aug 30, 2024Estimated

First Submitted Date

Jul 12, 2019

First Submission Date that Met QC Criteria

Jul 12, 2019

First Posted Date

Jul 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2019

Last Update Posted Date

Jul 16, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. William Tran, Radiation Therapist Clinician Scientist, Sunnybrook Health Sciences CentrePrincipal Investigator

Lead Sponsor

Sunnybrook Health Sciences CentreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The specific aims of the study are to (1) to identify clinicopathomic biomarkers from pre-treatment core biopsies that are predictive of response to neoadjuvant chemotherapy, (2) determine patterns of metastasis from primary breast cancer to other distant sites, (3) determine the rates of local recurrence in breast cancer patients, and (4) to determine if there are significant radiomic, pathomic, and clinical markers for recurrence and distant metastasis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

800Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiomic, pathomic, and clinical markers	Diagnostic Test	This is a non-interventional study.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pathologic complete response (pCR)	Evaluating the degree of absence of residual cancer cells	Up to 60 months

Secondary Outcomes

Measure	Description	Time Frame
Time to local breast recurrence	Evaluating the time until a recurrence event has occurred in the breast	Up to 60 months
Time to distant metastasis (months)	Evaluating onset of distant metastasis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Participants who had other primary cancers prior to breast cancer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sunnybrook Health Sciences Centre		Toronto	Ontario	M4N3M5	Canada

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All data will be anonymized. Digital pathology images and anonymized clinical data will be deposited into the National Cancer Institute (NCI) data sharing repository, including The Cancer Imaging Archive (TCIA). Digital pathology images will also be annotated to facilitate analysis for other investigators. Computational methods, source-codes and instructions will be deposited to the open-source coding repository, GitHub (www.github.com).

Types

Not provided

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.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D018270	Carcinoma, Ductal, Breast
D018275	Carcinoma, Lobular

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000097188	Radiomics

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided