INFLUENCE 2.0: Risk of Locoregional recurrence, secondary contralateral tum

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INFLUENCE 2.0: Risk of Locoregional recurrence, secondary contralateral tumors and distant metastasis in breast cancer

INFLUENCE 2.0 is a flexible model to predict time-dependent individual risks of LRR, SP and DM at a 5-year scale; it can support clinical decision-making regarding personalized follow-up strategies for curatively treated non-metastatic breast cancer patients.

Research authors: Vinzenz Völkel, Tom A. Hueting, Teresa Draeger, Marissa C. van Maaren, Luc J.A. Strobbe, Marjanka K. Schmidt, Gabe S. Sonke, Marjan van Hezewijk, Catharina G.M. Groothuis-Oudshoorn, Sabine Siesling

Version: 2.0

Public
Oncology
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V-2.0-2238.21.05.14

(01)08720299526440(8012)v2.0(4326)210514(240)2238

Details
Intended use
Electronic label
Languages

Details
Intended use
Electronic label
Languages

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The calculated results are based on models that have been developed using data of over 13000 patients who have been treated for breast cancer in the Netherlands.

The performance of the models have been evaluated on discrimination and calibration using 200 bootstrap samples. The C-index for locoregional recurrence, secondary primary contralateral breast cancer, and distant metastasis were 0.75, 0.67, and 0.77 respectively.

For calibration, all three models showed high levels of agreement between predicted and observed probabilities and <1% absolute differences on average.

In the data used to develop the model, the following event rates were observed:

Locoregional recurrence n = 385 (2.8%)
Secondary Primary Contralateral breast cancer n = 411 (3.0%)
Distant metastasis n = 848 (6.3%)
No event n = 11839 (87.7%)

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Calculations alone should never dictate patient care, and are no substitute for professional judgement. See our full disclaimer.

Underlying models Part of

Additional information

Details

Model author

T. A. Hueting

Model ID

2238

Version

2.0

Revision date

2021-05-14

Specialty

Oncology

Model type

R-Script model ^{(Calculation)}

MeSH terms

Breast Cancer

Rating

Status

Public

Formula
No Formula defined yet

Condition	Formula

Study characteristics

Additional information

Data on women diagnosed with non-metastatic invasive breast cancer were derived from the Netherlands Cancer Registry (n=13,494). To provide flexible time-dependent individual risk predictions for LRR, SP, and DM, three statistical approaches were assessed; a Cox proportional hazard approach (COX), a parametric spline approach (PAR), and a random survival forest (RSF).

These approaches were evaluated on their discrimination using the Area Under the Curve (AUC) statistic and on calibration using the Integrated Calibration Index (ICI). To correct for optimism, the performance measures were assessed by drawing 200 bootstrap samples.

Study Population

Total population size: 13494

Categorical characteristics

Name	Subset / Group	Nr. of patients
Grading	1	3409
Grading	2	6047
Grading	3	4038
pT stage	1	8692
pT stage	2	4514
pT stage	3	288
pN stage	0	8782
pN stage	1	3493
pN stage	2	790
pN stage	3	429
Multifocality	No	11425
Multifocality	Yes	2069
Surgery	Breast conserving surgery	7942
Surgery	Mastectomy	5552
Adjuvant chemotherapy	No	8366
Adjuvant chemotherapy	Yes	5128
Adjuvant radiotherapy	No	4403
Adjuvant radiotherapy	Yes	9091
Antihormonal therapy	HR+ & Therapy	6560
Antihormonal therapy	HR+ no therapy	4881
Antihormonal therapy	HR-	2053
Antibody therapy	HER2+ & therapy	678
Antibody therapy	HER2+ no therapy	1015
Antibody therapy	HER2-	11801
First event	LRR	385
First event	SP	411
First event	DM	848
First event	None	11839

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	Evidencio B.V., Irenesingel 19, 7481 GJ Haaksbergen, The Netherlands
	V-2.0-2238.21.05.14
	(01)08720299526440(8012)v2.0(4326)210514(240)2238
	Medical device

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This model has been certified as a medical device

V-2.0-2238.21.05.14

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The model INFLUENCE 2.0: Risk of Locoregional recurrence, secondary contralateral tumors and distant metastasis in breast cancer has been certified as a medical device and is only available to qualified Evidencio subscribers.

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The Service automatically collects information on how you use the Service, such as:

The IP-address used to connect your computer to the internet is stored for 5 years, by our web server for security, maintenance and product improvement purposes;
Computer, device, and connection information, such as browser type and version, operating system, mobile platform and other technical identifiers are collected in order to comply with e.g. medical device regulations;
Service usage information such as URL click stream data, including date and time stamp, referring- and exit-URLs, search terms you used, and pages you visited or searched for on the Service.

We may use information that does not reveal your identity or permit direct association with any specific individual, such as browser and device information, anonymous usage data, and aggregated information, for any purpose, except where we are restricted by law. If we combine non-Personal Data with Personal Data, the combined information will be treated as Personal Data for as long as it remains combined.

We make very limited use of cookies. We use an ‘Evidencio Cookie’, to which you agree in our display a terms of service agreement modal, when you first visit the Service. This Evidencio Cookie is only used to set a unique session-ID, so that we can safely provide our Service, and your inputs don’t get mixed with information from other Users. You can control cookies through your browser's settings and other tools. However, if you block certain cookies, you may not be able to register, log in to the Services, access certain parts of the Services or make full use of the Services.

2.3 Information You Provide

The type of personal information you provide to us may vary, corresponding to the ‘role’ you have when interacting with the Service.

2.4 General Website and Service Use

When using the Service as a visitor without account, you may provide information to us by:

Search terms you enter on the Service;
Model parameter values that you specify in the Service in order to calculate a result;
Your Name, Email address and Message, when using our contact form. Evidencio becomes the controller of this data, and processes this data on the basis of your consent to the processing.

This data is linked to the IP address that is collected automatically.

2.5 Registered Users

In order to access certain content and to make use of additional functionality and features of the Service, we ask you to register for an account by:

completing and submitting a registration form; and
accepting and agreeing to this ‘Privacy Policy’ and the ‘Terms & Conditions’.

In addition to the information you provide by your general use of the Service, you may provide us with:

Mandatory contact details:
- Username, Email Address, Occupation, Organizations
Optional contact details:
- First Name, Last Name, Address, Zip, City, Country, Website, Twitter-, Facebook-, LinkedIn-handle, a Profile Picture
Declarations
- Your declaration of having read, understood and agreed to our Terms of Use and Privacy Policy.
- Regarding the use of Medical Devices on the Service: your declaration of being a medical professional, and/or your declaration of adherence to the Medical Devices’ Intended Use.

2.6 Customers

Evidencio Customers, such as medical professionals, are also subject to the agreement as defined in the Paragraph ‘Registered Users’. They may be asked to provide additional information in order to fulfill the legal, administrative and financial obligations that need to be performed in the context of e.g. the use of Medical Devices as provided by the Service, such as:

Payment information, as required by our Payment Providers;
Your explicit warranty that you are qualified to use a specific medical device;
Your input, time-of-use, calculated output, when using any Medical Device on the Service.

If you choose to sign in and use the Service by using a third party account (e.g. your Hospital account), the authentication of your login is handled by the third party and the Service will collect your name, email address, and any other information about your third-party account that you agree to share with us at the time you give permission for your account on the Service to be linked to your third party account.

2.7 Organizations

Evidencio Services can be purchased by organizations. In the contract between Evidencio and the Organization, the Organization can determine the purposes for which and the means by which personal data is processed. In this scenario the Organization is the data controller and Evidencio becomes the data processor. In this agreement the data necessary for the execution of the contract will be specified, but will likely consist of the data mentioned under points 2.5 and 2.6. Evidencio will only process data that is necessary for the execution of that Data Processing Agreement.

2.8 Job Applicants

If you apply for a job with us, for example, in response to a vacancy posted by us, but also if you send us an open application, you may provide us with your personal data (for example by sending us an email with your CV). Evidencio is a data controller of this data. We process this data on the basis of our legitimate interest to send you a reply.

Any information you send us as part of a job application will be treated as personal information and will be destroyed once the job application process is concluded.
The fact that you provide us with your job application and personal information does not mean we are obligated to provide you with any response whatsoever.

2.9 Email contact

It is Evidencio’s legitimate interest to process your name, email and message to reply to your support request, comments, questions or business inquiries, and customer support. This applies when you send an e-mail directly to Evidencio.

3. USE OF YOUR INFORMATION

We may use your Personal Data to:

Provide the Service to you, by e.g. allowing access to, or delivery of our products or services, processing or fulfilling orders or transactions, or administering surveys or promotional programs;
Respond to your requests, inquiries, comments, or concerns;
Provide technical-, product-, and other support and help ensure safe and secure operation of the Service;
Offer you customized content and individualized personalization of the Service to make it more relevant to your interests and needs;
Enhance, evaluate, and improve the Service, its advertisements and promotional campaigns and our products and services and to develop new products and services;
Identify and analyze usage trends, including for the purposes of research, audits, reporting and paying royalties and license fees to third-party content providers;
Notify you about changes or updates to the Service and our other products and Services;

We do not make automated decisions based on your Personal Data.

4. DISCLOSURE OF YOUR INFORMATION

We may need to share a subset of your Personal Data with:

Relevant entities, and representatives, for which we are acting as a partner, agent, licensee, or publisher, such as 3rd party IP-holders. These entities or representatives are always explicitly mentioned in relation to Service Content or within (Data Processing) Agreements governing your access to such Content;
Applicable suppliers and service providers, including editors, reviewers, credit card processors, customer support, email service providers, but only in order to assist us with producing and delivering our products and Services, developing and operating our businesses, systems and applications, processing payments, providing customer support, communications, and for other purposes set forth in this privacy policy.

We also may need to disclose your Personal Data:

To respond to or comply with any law, regulation, subpoena, court order or other legal obligation;
To enforce and protect our rights and properties;
To detect, investigate and help prevent security threats, fraud, loss, theft, misuse, unauthorized access, disclosure, alteration, or destruction if information;
To protect the rights, property or safety of our Users, employees or others; and

The Service may let you post and share Personal Data, comments, materials and other content. Any information you disclose publicly may be collected and used by others, may be indexable by search engines, and might not be able to be removed. Please be careful when disclosing Personal Data in these public areas.

5. YOUR ACCESS TO YOUR INFORMATION

You have a right to be informed on Personal Data processed by the Service, a right to rectification/correction, erasure and restriction of processing. Upon request, you have the right to receive a structured, common and machine-readable format of the Personal Data you provided to us. We may need to request specific information from you to help us confirm your identity and ensure your right to access your Personal Data (or to exercise any of your other rights). This is a security measure to ensure that you are the data subject entitled to receive such Personal Data.

Access to your Personal Data will be provided free of charge. However, we may (in advance) charge a reasonable compensation should your request be clearly unfounded, repetitive, or excessive. At our sole discretion we may refuse to comply with your request in these circumstances.

As a registered User you can access your account information and make corrections or updates at any time. The accuracy of such information is solely your responsibility.

Where you have provided consent, you may withdraw it at any time, without affecting the lawfulness of the processing that was carried out prior to withdrawing it. Whenever you withdraw consent, you acknowledge and accept that this may have a negative influence on the scope and quality of the Service. We will endeavor to fulfill your request within 30 days but some Personal Data may persist in backup copies for a certain period of time and may be retained as necessary for legitimate business purposes or to comply with our legal obligations. You agree that Evidencio BV shall not be held liable regarding any loss and/or damage to your Personal Data if you choose to withdraw consent.

To exercise any of the rights mentioned in this Privacy Policy and/or in the event of questions or comments relating to the use of your Personal Data, you may contact Evidencio at: privacy@evidencio.com

You have the right to file a complaint with the data protection authority in your jurisdiction. However, we would very much appreciate it if you would file your complaint with us before going to a data protection authority.

6. DATA RETENTION

Evidencio acts as a Data Controller regarding your Personal Data. As such, we have defined data retention policies regarding your Personal Data.

Data retention:

Information you provide as part of your User profile will be stored as long as your profile exists. In part some information may be retained longer due to legal requirements (e.g. due to legislation medical device use)
Information you provide as part of your Service Subscriptions (e.g. payment, tax, or company information) we are required by law to retain for 10 years.
Information we collect automatically: 5 years.
In case you use the Service as part of your employment at an organization that has an Evidencio Subscription with associated Data Processing Agreement in place. Particular details on data retention regarding tour use of the Service may be specified in the respective Data Processing Agreement.
Information you have given us for contacting you, including e-mail address and messages, regarding any medical device, needs to be retained up to 10 years after the last medical device has been placed on the market for safety reasons.

You should be aware that we may retain certain Personal Data to comply with legal obligations, resolve disputes and enforce our agreements.

7. DATA SECURITY

Evidencio has taken every reasonable precaution to safeguard your Personal Data against loss, theft, misuse, unauthorized access, disclosure, alteration, and destruction through the use of appropriate administrative, physical and technical security measures.

Our company and Services have been ISO27001 and NEN7510 certified.

As part of our obligations under these information security certifications our Service is periodically scanned for security holes and known vulnerabilities in order to make your visit to our site as safe as possible. Your Personal Data is contained behind secured networks and is only accessible by a limited number of persons who have special access rights to such systems, and are required to keep the information confidential.

Personal Data and usage data is stored as long as is necessary for the purpose(s) for which we originally collected it. We may also retain information as required by law.

8. CROSS-BORDER TRANSFER OF INFORMATION

Evidencio’s Service is hosted on Amazon AWS cloud infrastructure. We currently use AWS Services located in Ireland and Germany. Your Personal Data may be transferred to either Ireland or Germany for processing. By using the Service, you consent to the transfer of information to these countries which may be outside of your country of residence, and which may have different Personal Data protection rules than in your country.

9. CHANGES TO OUR PRIVACY POLICY

We may change this privacy policy from time to time, at our sole discretion. Any changes will be posted on this page with an updated revision date.

10. LINKS TO THIRD PARTY PRODUCTS & SERVICES

The Service may, at our discretion, include or offer third-party products or services. These third-party products or services may have separate and independent privacy policies. We, therefore, have no responsibility or liability for the content and activities of these linked products or services. Nonetheless, as we endeavor to protect the integrity of our Service, we welcome any feedback regarding these third-party products and services.

11. COMPLIANCE WITH LOCAL LAWS

11.1 EU General Data Protection Regulation (“GDPR”)

We carry out all data control and processing operations in strict compliance with the GDPR. We use a limited number of external service providers that are trusted and meet high data protection and security standards for certain tasks such as technical data analysis, processing and/or storage offerings. We only share information with them that is required for the services offered, and we contractually bind them to keep any information we share confidential. We will not pass your data on to third parties without your express consent unless we are obliged to do so by statutory law or an instruction from a public authority or court.

11.2 California Online Privacy Protection Act

Users can visit our site anonymously. This privacy policy is available through a clear link on every page on our site. Our Privacy Policy link includes the word 'Privacy' and can be easily be found on any page on the site. Users that opt to create an account on our site will be notified of any privacy policy changes when they login to their account.
We honor “do not track” signals and do not track, plant cookies (other than a functionally required session cookie), or use advertising when a Do Not Track (DNT) browser mechanism is in place.

Should a data breach occur;

We will notify the Users via email within 7 business days.
We also agree to the Individual Redress Principle.
We do not market to children under 13.
Please note that we allow third-party behavioural tracking to improve our Service and our user experience.

11.3 CAN-SPAM ActPrivacy Protection Act

If at any time you would like to unsubscribe from receiving future emails from Us, you can email us at privacy@evidencio.com and we will promptly remove you from ALL correspondence.

12. CONTACT

If you have any questions, comments or requests regarding this privacy policy or our processing of your information, please contact:

Evidencio BV
Attn: Privacy Officer
Irenesingel 19
7481 GJ
Haaksbergen
the Netherlands
privacy@evidencio.com

Last revised: June 09^th, 2023

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