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.
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
About this study
Official title: Clinical Study of Imaging Genomics Based on Machine Learning for Breast Cancer Molecular Typing and Risk Prediction (BCIG)
- Identify the imaging features of breast cancer with different molecular types
- Reveal the association between hormone receptor positive/HER2 negative breast cancer and imaging histology, Oncotype Dx recurrence score
- Combine genomics and imaging to establish a predictive model for the sensitivity of HER2-positive breast cancer targeted therapy
- 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
- Research on the molecular typing of breast cancer based on imaging features
- Establish a Luminal breast cancer recurrence risk prediction model
- Establish HER2 targeted therapy sensitivity prediction model
- 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.
- Conditions
- Breast Cancer, Molecular Typing, Pathology, Image, Body
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Multidisciplinary cooperative comprehensive treatment | |
| HER2 overexpression | ER- PR-,HER2+
* ER:estrogen receptor PR:progesterone receptor HER2:human epidermalgrowth factor receptor-2 Receives: Procedure: Multidisciplinary cooperative comprehensive treatment | |
| Triple negative | ER- 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.
Image prediction model of different molecular typing
- Build a model to predict molecular typing based on image
- Establish a prediction model for predicting the risk of Luminal breast cancer recurrence
- Establish a prediction model for predicting her2 targeted drug resistance
- 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.
- First posted8 Jul 2020
- Study start1 Dec 2020 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, International Peace Maternity and Child Health Hospital
- Responsible party
- Principal investigator, Guyajia, Fudan University
- Investigators
- Gu Ya Jia, Principal investigator, Fudan University
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Imaging Genomics Based on Machine Learning for Breast Cancer Molecular Typing and Risk Prediction (BCIG)
- ClinicalTrials.gov ID
- NCT04461990
- Acronym / sponsor ID
- BCIG
- Conditions
- Breast Cancer, Molecular Typing, Pathology, Image, Body
- Keywords
- breast cancer, Pathology, Molecular Typing, magnetic resonance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- RenJi Hospital, International Peace Maternity and Child Health Hospital
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Identify the imaging features of breast cancer with different molecular types
- Reveal the association between hormone receptor positive/HER2 negative breast cancer and imaging histology, Oncotype Dx recurrence score
- Combine genomics and imaging to establish a predictive model for the sensitivity of HER2-positive breast cancer targeted therapy
- 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
Detailed description
Research design
- Research on the molecular typing of breast cancer based on imaging features
- Establish a Luminal breast cancer recurrence risk prediction model
- Establish HER2 targeted therapy sensitivity prediction model
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Luminal | – | Procedure: Multidisciplinary cooperative comprehensive treatmentLuminal 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 |
| HER2 overexpression | – | Procedure: Multidisciplinary cooperative comprehensive treatmentER- PR-,HER2+ * ER:estrogen receptor PR:progesterone receptor HER2:human epidermalgrowth factor receptor-2 |
| Triple negative | – | Procedure: Multidisciplinary cooperative comprehensive treatmentER- PR-,HER2- * ER:estrogen receptor PR:progesterone receptor HER2:human epidermalgrowth factor receptor-2 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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)
Key inclusion criteria (3 listed)
- Pathological and immunohistochemical diagnosis of breast cancer by biopsy
- No MRI contraindications and no biopsy before MRI
- Without radiotherapy and chemotherapy before enrollment
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary cooperative comprehensive treatmentLocal surgery, radiation therapy, and systemic therapy such as chemotherapy, endocrine and molecular targeting. | Procedure or surgery | HER2 overexpression, Luminal, Triple negative |
Primary outcome
Image prediction model of different molecular typing
Time frame: 30 December,2022----30 December,2023
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gu Ya Jia principal investigator
Fudan University
1 site in 1 country: see every site and its status.
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.