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Status unknownNCT04461990Updated Aug 21, 2020

Clinical Study of Imaging Genomics Based on Machine Learning for BCIG

An observational study in Breast Cancer, Molecular Typing and Pathology, sponsored by Fudan University. Status unknown at 1 site in China. Open to female participants. Per ClinicalTrials.gov, last updated 2020-08-21.

Sponsored by Fudan University · Observational

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Sex
Female
01

Study summary

  1. Identify the imaging features of breast cancer with different molecular types
  2. Reveal the association between hormone receptor positive/HER2 negative breast cancer and imaging histology, Oncotype Dx recurrence score
  3. Combine genomics and imaging to establish a predictive model for the sensitivity of HER2-positive breast cancer targeted therapy
  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
Read the detailed description

Research design

  1. Research on the molecular typing of breast cancer based on imaging features
  2. Establish a Luminal breast cancer recurrence risk prediction model
  3. Establish HER2 targeted therapy sensitivity prediction model
  4. Establish TNBC molecular subtype prediction model Research methods Research Object This study used a multi-center study to prospectively enroll breast cancer patients diagnosed with pathology. All enrolled patients had complete clinical data, including demographic characteristics (gender, age, menstrual status and fertility history), and pathological data (histopathological data). Staging, immunohistochemical 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).

Magnetic resonance examination In order to maintain the comparability between the images and reduce the systematic errors, each center selects a fixed MR device for scanning. Among them, a. Oncology Hospital chose to scan images with 3.0T (Siemens Skyra) MR equipment. A special breast coil is used to add high-definition diffusion-weighted scanning and multi-b value diffusion-weighted scanning before the dynamic enhancement scan. Dynamically enhanced acquisition in 5 phases with a time resolution of 65s. b. Renji Hospital uses Netherlands Philips Achieva 3.0 T superconductor MR scanner, 4-channel dedicated breast phased array coil. Scanning sequences include T1WI, T2WI, T2WI fat suppression, DWI and DCE-MRI. The contrast agent was Gd-DTPA, with a dose of 0.1 mmol/kg, an injection rate of 2.0 mL/s, and an additional 20 mL of saline was added to the tube after injection. The T1WI scan was performed first, and 5 time phases were continuously scanned after the injection of contrast agent, and each time phase was separated by 61 s, for a total of 6 time phases. c. Chinese women and babies are scanned with 1.5T SIEMENS AERA MR equipment and special breast coils. Scanning sequence includes 5 phases of T1WI, T2WI fat suppression, DWI and dynamic enhancement scan, time resolution 71s.

Image processing Use software to make semi-automatic and automatic outlines of the tumor interest area, and make the outline of the tumor solid enhancement part, the entire tumor area and the surrounding edema zone in the transverse position. In order to accurately delineate the tumor, compare the T1 and T2 weighted and dynamically enhanced images, two imaging physicians are responsible, one is responsible for delineation and the other is reviewed, and the disputed area is determined after discussion by a third person. Create a dynamic enhanced tumor texture analysis program to automatically extract imaging omics features in the region of interest. Using a labeled data set, a computer-based automatic segmentation algorithm model based on machine learning is constructed to automatically extract regions of interest, and segmentation performance evaluation is performed on manually delineated labels.

Statistical analysis Perform statistical analysis on the obtained images and clinical data, extract image omics features and use machine learning algorithms to screen important features. Use statistical tools such as SPSS and R language. Paired t test (continuous variable) and chi-square test (discontinuous variable) were used to compare the clinical and imaging characteristics of patients with different prognosis; correlation analysis was used to evaluate the imaging histology characteristics and different pathological tissue grades, Correlation between lymph node metastasis and specific gene expression; use Kaplan-Meier survival curve to analyze the prognostic difference between patients with different imaging omics characteristics, and use log-rank method to test the difference; use cox survival model to compare clinical characteristics and imaging omics The characteristics and prognosis of patients (tumor-free survival, progression-free survival, overall survival) were analyzed by multiple factors. Further, deep learning algorithms can be used to automatically learn imaging omics features that may be related to molecular subtypes and prognosis to build prediction models.

02

Conditions studied

  • Breast Cancer
  • Molecular Typing
  • Pathology
  • Image, Body

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Keywords

  • breast cancer
  • Pathology
  • Molecular Typing
  • magnetic resonance
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability 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)

Inclusion criteria

  1. Pathological and immunohistochemical diagnosis of breast cancer by biopsy
  2. No MRI contraindications and no biopsy before MRI
  3. Without radiotherapy and chemotherapy before enrollment

Exclusion criteria

Exclusion Criteria:

  1. Those with previous history of breast cancer surgery, hormone replacement therapy and chest radiotherapy
  2. Patients with severe diseases who cannot cooperate with the examination
  3. People with contraindications to MRI
  4. The researchers believe that other conditions are not suitable for breast MRI examination
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • 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

  • ProcedureMultidisciplinary cooperative comprehensive treatment

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

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What researchers measure

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

    Time frame: 30 December,2022----30 December,2023

07

Study locations

1 site
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai 200032, China
    • Gu Ya Jia · Contact · guyajia@126.com · 86-18017312040
    • Hua jia · Principal investigator
    • Qian zhaoxia · Principal investigator
    • Wang he · Principal investigator
    • You chao · Sub investigator
    • Zhuang zhiguo · Sub investigator
    • Jiang ling · Sub investigator
    • Zheng rencheng · Sub investigator
    • Xiao qin · Sub investigator
    • Chen yanqiong · Sub investigator
    • Hu xiaoxin · Sub investigator
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04461990
Lead sponsor
Fudan University
Collaborators
RenJi Hospital, International Peace Maternity and Child Health Hospital
Responsible party
Guyajia (Director of Radiology, Fudan University) — Principal investigator
First posted
Jul 8, 2020
Start date
Dec 1, 2020 (estimated)
Primary completion
Dec 30, 2022 (estimated)
Completion
Dec 30, 2023 (estimated)
Last update
Aug 21, 2020

Study contacts

Gu Ya Jia
Contact
guyajia@126.com
86-18017317817
Gu Ya Jia
principal investigator · Fudan University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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