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Breast CancerNCT04461990

Clinical Study of Imaging Genomics Based on Machine Learning for BCIG

An observational study of Breast Cancer and Molecular Typing, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Breast Cancer, Molecular Typing, Pathology
What is being tested?
Multidisciplinary cooperative comprehensive treatment
Type of treatment
Surgery or procedure
How many people
1,500 participants
Where
1 siteChina
Study dates
1 Dec 2020to 30 Dec 2023
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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)

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site
  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Gu Ya Jia, 86-18017312040, guyajia@126.com

    Hua jia

Other trials in China

About this study

Official title: Clinical Study of Imaging Genomics Based on Machine Learning for Breast Cancer Molecular Typing and Risk Prediction (BCIG)

  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.

Being tested
Multidisciplinary cooperative comprehensive treatment
Keywords
breast cancer, Pathology, Molecular Typing, magnetic resonance
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multidisciplinary cooperative comprehensive treatmentProcedure or surgery

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

Study groups in NCT04461990
Study groupRoleWhat they receive
LuminalLuminal 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
Receives: Procedure: Multidisciplinary cooperative comprehensive treatment
HER2 overexpressionER- PR-,HER2+ * ER:estrogen receptor PR:progesterone receptor HER2:human epidermalgrowth factor receptor-2
Receives: Procedure: Multidisciplinary cooperative comprehensive treatment
Triple negativeER- PR-,HER2- * ER:estrogen receptor PR:progesterone receptor HER2:human epidermalgrowth factor receptor-2
Receives: Procedure: Multidisciplinary cooperative comprehensive treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 30 December,2022----30 December,2023

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2020
  2. Study start1 Dec 2020 (estimated)
  3. Primary completion30 Dec 2022 (estimated)
  4. Study completion30 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04461990
Sponsor's protocol ID
BCIG
Status last verified
Aug 2020
First submitted
4 Jul 2020
Last updated
21 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Molecular Typing, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gu Ya Jia (86-18017317817, guyajia@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Image prediction model of different molecular typing (time frame: 30 December,2022----30 December,2023). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2020; AzTrials last refreshed its copy on 31 Oct 2026.

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