NCT04461990

Brief Summary

  1. 1.Identify the imaging features of breast cancer with different molecular types
  2. 2.Reveal the association between hormone receptor positive/HER2 negative breast cancer and imaging histology, Oncotype Dx recurrence score
  3. 3.Combine genomics and imaging to establish a predictive model for the sensitivity of HER2-positive breast cancer targeted therapy
  4. 4.Establish an imaging genomics prediction model for triple-negative breast cancer molecular subtypes, and clarify the imaging genomics characteristics of the therapeutic targets of each subtype

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

August 21, 2020

Status Verified

August 1, 2020

Enrollment Period

2.1 years

First QC Date

July 4, 2020

Last Update Submit

August 20, 2020

Conditions

Breast CancerMolecular TypingPathologyImage, Body

Keywords

breast cancerPathologyMolecular Typingmagnetic resonance

Outcome Measures

Primary Outcomes (1)

  • Image prediction model of different molecular typing

    1. Build a model to predict molecular typing based on image 2. Establish a prediction model for predicting the risk of Luminal breast cancer recurrence 3. Establish a prediction model for predicting her2 targeted drug resistance 4. Establishing a triple-negative molecular model for breast cancer

    30 December，2022----30 December，2023

Study Arms (3)

Luminal

Luminal A：ER+ and/or PR+,HER2- Luminal B：ER+ and/or PR+,HER2+ \* ER:estrogen receptor PR:progesterone receptor HER2:human epidermalgrowth factor receptor-2

Procedure: Multidisciplinary cooperative comprehensive treatment

HER2 overexpression

ER- PR-,HER2+ \* ER:estrogen receptor PR:progesterone receptor HER2:human epidermalgrowth factor receptor-2

Procedure: Multidisciplinary cooperative comprehensive treatment

Triple negative

ER- PR-,HER2- \* ER:estrogen receptor PR:progesterone receptor HER2:human epidermalgrowth factor receptor-2

Procedure: Multidisciplinary cooperative comprehensive treatment

Interventions

Multidisciplinary cooperative comprehensive treatmentPROCEDURE

Local surgery, radiation therapy, and systemic therapy such as chemotherapy, endocrine and molecular targeting.

HER2 overexpressionLuminalTriple negative

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Prospectively enrolled breast cancer patients diagnosed by pathology, all clinical data of all enrolled patients are complete, including demographic characteristics (gender, age, menstrual status and fertility history), pathological data (staging in histopathology, immunohistochemistry) Status and FISH, genetic testing records the recurrence score and genotype), imaging data, complete treatment and follow-up (whether there is local recurrence and metastasis, and the time of diagnosis)

You may qualify if:

  • Pathological and immunohistochemical diagnosis of breast cancer by biopsy
  • No MRI contraindications and no biopsy before MRI
  • Without radiotherapy and chemotherapy before enrollment

You may not qualify if:

  • Those with previous history of breast cancer surgery, hormone replacement therapy and chest radiotherapy
  • Patients with severe diseases who cannot cooperate with the examination
  • People with contraindications to MRI
  • The researchers believe that other conditions are not suitable for breast MRI examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Gu Ya Jia

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gu Ya Jia

CONTACT

86-18017317817guyajia@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Radiology

Study Record Dates

First Submitted

July 4, 2020

First Posted

July 8, 2020

Study Start

December 1, 2020

Primary Completion

December 30, 2022

Study Completion

December 30, 2023

Last Updated

August 21, 2020

Record last verified: 2020-08

Locations

CN(1)