ONCOVALUE opens call for expressions of interest to participate in project’s validation activities

Interested cancer centres can apply by following the below steps:

1. Express interest by contacting ONCOVALUE Project Manager Nea Hellman via email at
   nea.hellman@hus.fi while the call is open.
2. Accept terms for application*.
3. Fill in the provided survey by March 9 th , 2025 (a link will be shared via email).
4. The survey results are analysed by the project and potential centres are selected based on
   the results.
5. Selected centres are contacted, and exact extent and terms of participation are agreed
   upon.
6. Studies are initiated in the selected centres.

*Completion of the survey (step 3) does not guarantee participation in the ONCOVALUE project as centres will be selected based on the analysis of the survey results. Filling in the survey is a requirement for consideration. The estimated time to complete the survey is 20 minutes. The ONCOVALUE project reserves the right to utilize the survey responses in an aggregated format also for centres that are not selected for further participation.

The call for expressions of interest is open from February 10 th , 2025, until March 9 th , 2025, during which time interested centres will be granted access to fill in the application survey which is a requirement for participation. Survey results are to be submitted before the call closes. The selected centres will be contacted by approximately end of March 2025, and the first studies will be initiated in the selected centres around May 2025.

Before applying, please ensure support from the appropriate level of management to be able to
enter contract preparations if selected.

The requirements for participation are dependent on the scope and extent of validation performed. These will be agreed upon with selected centres in the contract preparation phase, depending on the interests, capacity and capabilities of the applicant cancer centre. The ‘call for expressions of interest’ (link to document) outlines criteria for participating sites (section 1.3). The minimum requirements for all applicants are:

• Member of the Organization of European Cancer Institutes (OECI) offering treatment for
  breast cancer and/or lung cancer patients
• Electronic Health Records (EHRs), preferably from at least 2015 onwards
• Ability to dedicate or consult a data analyst and/or expert for data curation and running R
  analysis scripts (if needed) as well as a clinician for participation duration

Applicants are requested to confirm that the listed criteria are met during the application process.

Validation is conducted by pilot studies in the breast cancer setting or in the non-small cell lung cancer (NSCLC) setting. The breast cancer study aims to validate the hybrid RWD-based HTA- framework to estimate the cost effectiveness of immunotherapy (pembrolizumab) compared to the standard of care as neoadjuvant treatment in patients diagnosed with early-stage triple-negative breast cancer (TNBC). The applicant-centre could either apply only for the standard of care arm or immunotherapy or both. The study also aims to apply the AI-tool developed for medical images to follow the progression of the disease to metastatic stage in a sub cohort of this group of patients.

The lung cancer study, using the guidelines and SOPs developed for the collection and processing of structured RWD, and the AI-tool for text from medical reports, primarily aims at replicating a clinical trial setting that includes patients with mutation-positive advanced NSCLC and who were treated with TKIs with those obtained in a real-world setting similar to that of the clinical trial.

Not all validation objectives are required to be met by all participating hospitals. The level of validation depends on the interests, capacity and capabilities of the applicant cancer centre. For example, participation in the proposed validation of the developed AI-tools is optional. However, each new participating centre is expected to provide either aggregated analysis results or anonymized/pseudo-anonymised patient-level data according to provided study protocols. The specific level of anonymity for shared data will be determined individually with each selected centre.

The project will fund the validation activities based on the level/extent of validation and the income level of the participating hospital. ONCOVALUE is looking to acquire 3-5 additional clinical sites with approximately 30.000 – 60.000 € validation budget per site. The exact budget will be negotiated with the selected hospitals.

Hospitals from non-EU countries can also apply and are eligible to receive funding unless there are specific limiting conditions, such as being subject to the EU restrictive measures, under Article 29 of the Treaty on the European Union (TEU) and Article 215 of the Treaty on the Functioning of the EU (TFEU) and listed in the EU Sanction Map. More specific information on specific countries can be found in the List of Participating Countries in Horizon Europe.

All possible participation is required to be conducted under equivalent conditions as legal entities from EU member states, with respect to European law (e.g., to the GDPR) as well as security and scientific & clinical requirements.

The validation of the solutions developed within the project will take place during 2025 and 2026. The first studies will be initiated in the selected cancer centres by May 2025.

The AI tool for medical images will automatically assess cancer progression of breast cancer patients with metastases in the lung or liver from longitudinal CT scans. The aim of the tool is to enable hospitals to assess which therapies are effective in the treatment of metastatic breast cancer by providing information on disease progression.

The AI tool for medical texts will extract structured outcomes for specific variables from unstructured medical notes to enable analytics of real-world evidence (RWE) on the effectiveness of cancer therapies. This Natural Language Processing (NLP) tool is available in Dutch and in Finnish.

The needed resources are attached to the extent of activities performed. The resources and extent of activities will be discussed and agreed upon with the selected hospitals in the contract preparation phase.

Yes, if the missing criterion is not stated as mandatory for participation (see also ‘What specifically is required from our hospital to be able to participate?’).

We are currently looking for hospitals outside of the consortium to validate the solutions developed in the project. We are not looking for additional consortium members at this time.