Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Patients will receive digital assistance (in a few words text format) for any symptoms/adverse events they will include in their profile in the digital platform.

Patients will just include any symptoms/adverse events in their profile in the digital platform.

Patients will be randomized (1:1) in the way they will receive or not any assistance from the digital platform.

Digital platform

Paris Kosmidis, MD

Ilias Athanasiadis, MD

Athansios Kotsakis, MD

Joseph Sgouros, MD

Helena Linardou, MD

Elena Linardou, MD

Ioannis Mountzios, MD

Ioannis Mountzios

Christos Panopoulos, MD

Nikolaos Tsoukalas, MD

Dimitrios Bafaloukos, MD

Epameinontas Samantas, MD

Anastasios Vagionas, MD

Anastasios Vagionas

Athina Christopoulou, MD

Angelos Koutras, Ass. Prof.

Angelos Koutras, MD

Eleni Fountzilas, MD

Sofia Lampaki, MD

The purpose of this study is to provide high quality oncology services to patients with inoperable Non-Small Cell Lung Cancer (NSCLC) in Greece. These services will be based on 3 pillars:

1. Clinical: personalized treatment will be administered and its effectiveness and safety will be recorded and evaluated.
2. Molecular: the gene footprint of each patient at the beginning of his treatment, the molecular identity of his tumor will be analyzed and recorded based on analysis with modern Next Generation Sequencing (NGS) techniques.
3. Digital: Patients will have access to the digital platform where they will record the adverse reactions they will face during their treatment.

Lung cancer is the primary cause of cancer death worldwide regardless of gender or age group. Based on the most recent statistics for our country, every year about 9000 new cases of lung cancer are diagnosed. Lung cancer is the most common type of cancer in Greece in both men and women. It is estimated that about 8000 people lose their lives annually from this disease, while the total number of deaths from lung cancer seems to exceed in number the sum of deaths due to breast, prostate and colorectal cancer.

For many decades chemotherapy was the cornerstone and the only treatment option for lung cancer. In the last 20 years, the discovery and study of various molecular subtypes in non-small cell lung cancer has led to the development of targeted therapies. Modern oncology has multiple targeted therapies for corresponding molecular subtypes, such as ROS-1 rearrangements, amplifications and mutations of the MET gene, RET rearrangements, mutations of the BRAF gene, NTRK gene fusions, HER2 gene mutations, as well as KRAS mutations.The detection of molecular pathways, targeted mutations and biomarkers is a critical step in the diagnosis and treatment of patients with non-small cell lung cancer, in both early and advanced stage.The use of NGS (Next Generation Sequencing) technology as modern tool for accessing genetic material is adopted by more and more clinicians worldwide. The molecular analysis of the tumor with the technique of NGS, is considered as a necessity in the practice of modern oncology in order the patients to receive the best treatments for their disease.

a) Clinical pillar: In this study will be included 200 patients, 18 years old and older, with PS 0-2, treated for inoperable NSCLC stage IV. Patient will be treated according to the local standard of care based on their medical history. b)After signing the Informed Consent patients will provide biological material (blood samples and Formalin fixed paraffin embedded tissues) in order to proceed with the molecular arm of the study and the extended NGS analysis. In addition to molecular analysis, an economic analysis of the use of health resources will follow for a detailed understanding of the relevant financial aggregates and the improvement of the performance of existing resources. c) On the digital arm each patient will have access in the digital platform of CAREACCROSS which allows continuous and remote access for both patient and their physician with absolute security and data privacy.

All patients will be included in the digital monitoring and information program from their mobile phone and will have contact the investigator and the study team.

Blood samples and Formalin Fixed Paraffin Embedded tumour tissue

Clinical and Molecular Study With Digital Support of Patients With Inoperable Lung Cancer

Stavros Niarchos Foundation

Care Across Ltd

Hellenic Cooperative Oncology Group

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Breast Neoplasms

Breast Diseases

Skin Diseases

Quality of Life

Using an Artificial Intelligence approach integrated in a cloud-based healthcare platform CANKADO to give the patient complete information about the proposed type of locoregional treatment and access to photographs and data of patients with similar characteristics previously treated with the same technique. All interaction will be through the CANKADO Platform.

The standard approach of proposing patients for locoregional treatment with or without printed or digital materials and hypothetic visualization of results.

A previous large database repository of images having thousands of pre and postoperative photographs of breast cancer patients proposed for locoregional treatment with clinical and biometric data will be matched using artificial intelligence within the CANKADO platform. Patients proposed for breast cancer locoregional treatment will have access to the software installed, and they will have access to all the information about the type of treatment they will receive. All the questions and questionnaires will be filled out online, and they can visualise the expected outcome from excellent to poor.

Artificial Intelligence and Digital Health Arm

Maria-Joao Cardoso, MD, PhD

Martina Manns

Joerg Heil, MD, PhD

Michaela Ofir

Orit Kaidar-Person, MD, PhD

Dov Zippel

Nama Hermann

Josef Haik

Thierry Touvier

Oreste Gentilini, MD, PhD

Rosa di Mico

Pawel Kabata, MD, PhD

Mateusz Kirjak

Maciej Bobowicz, MD, PhD

Elzbieta Senkus-Konefka, MD, PhD

Eduard-Alexandru Bonci, MD, PhD

Carlos Mavioso, MD

Pedro Gouveia, MD, PhD

David Pinto, MD

Rogelio Andrés-Luna, MD

Maria-Joao Cardoso, PhD

Breast cancer is the most commonly diagnosed cancer, with an estimated 2.3 million new cases per year globally. Approximately 90% of these patients will undergo breast surgery with/without radiation (locoregional treatment). Different surgical techniques can be offered to the patient, each leading to completely different aesthetic outcomes. Moreover, the aesthetic outcome could be completely different for patients undergoing the same surgery based on individual patient factors (e.g., age, body habitus). In the CINDERELLA trial, the investigators will be using the (Breast Locoregional (BreLO) AI system (an artificial intelligence-based tool for the classification of aesthetic outcomes and matching data and photographs) integrated into CANKADO (a cloud-based healthcare platform) to create an easy-to-use application that can be used on any electronic device, to simulate visually to the patient the aesthetic outcome of a certain surgery or radiation treatment. In the CINDERELLA trial, the investigators plan to compare whether the application helped fulfil the expectations and lead to a better quality of life compared with the classical approach. In the classical approach (control arm), doctors usually propose a locoregional treatment and explain theoretically how the result will be. Nurses help by explaining further details about the surgery and possible outcomes. In most centres, no photographic evaluation is done, and expectations are not measured. The CINDERELLA trial will help overcome miscommunication and potential boundaries in the patient's or physician's understanding of the potential outcomes of locoregional breast cancer treatment.

The CINDERELLA clinical trial will be an open, prospective randomized trial that Champalimaud Foundation will coordinate. Five clinical centres agreed to participate in the trial. The trial will be designed and reported according to the latest SPIRIT-AI and CONSORT-AI guidelines.

The randomization will be made by adopting a dynamical approach following the Minimization Method. Assignment of the recruited patients to the study arms will take into account the stratification of the participants (younger and older than 50 / breast-conserving or mastectomy / mastectomy with or without radiotherapy), aiming to reduce bias and confounding by assuring the balance of the group.

After being proposed to the trial and checked for all the eligibility criteria, patients will be given the complete patient information before signing the informed consent.

For the five centres, a minimum of 515 patients should be enrolled in each arm of the study. After randomization, the patient will either follow:

1. - The intervention arm with the CINDERELLA APProach with the introduction and access to CANKADO with the BreLO AI system. The Expectations Questionnaire, Healthcare Professionals Multidimensional Evaluation Questionnaire and standard patient-reported outcomes measures (PROMs) (EQ-5D-5L and BREAST Q ICHOM) will be filed electronically. Standard photographic capture will be taken at this point. After the photographic capture, the BreLO-AI will match the patient biometrics and images with the more identical case existing in the BreLO repository and already classified by the BCCT.core into excellent, good, fair and poor. The new patient can then visualize the results. In case of doubts, queries will be answered through the app or, if needed, by phone call or booking another appointment. Questionnaires and Photographs will be repeated after wound healing is complete, six months and one year after the end of treatment (surgery or radiotherapy if radiotherapy was done).
2. - The control arm with the Conventional approach with a theoretical explanation by the doctor/nurse of the proposed locoregional treatment and possible outcomes. The Expectations Questionnaire, Healthcare Professionals Multidimensional Evaluation Questionnaire and standard PROMs (EQ-5D-5L and BREAST Q ICHOM) will be filed electronically. Standard photographic capture will be taken at this point. In case of doubts, the patient will book another appointment with the doctor/nurse, as usually done in routine practice. Questionnaires and Photographs will be repeated after healing is complete, six months and one year after the end of treatment (surgery or radiotherapy if radiotherapy was done).

Digital Photography (same protocol for all participating centres) - a similar protocol for image capture will exist for all centres. The standalone photography with an automatic robot will be progressively implemented (www.photorobot.com).

DATA COLLECTION

PATIENT-RELATED FACTORS

* Date of birth, Weight / Height / BMI, Thoracic perimeter, Bra size and cup
* Education degree, Profession, Hobbies
* Marital status, Pregnancies and offspring
* Breast-feeding, Menopausal status
* Smoking
* Connective tissue diseases
* Confirmed Pathogenic Germline Variant

TUMOUR-RELATED FACTORS

* Unilateral (unifocal, multifocal, multicentric) Bilateral
* Histological type according to World Health Organization (WHO) classification (e.g., invasive ductal carcinoma, lobular carcinoma) (size in mm) staging ER, PR, Her2, Ki67, cTNM - pTNM / ypTNM

TREATMENT-RELATED FACTORS

\*Type of Surgery/ Type of Reconstruction: (data collection regarding surgery should also include acellular dermal matrice (ADM) if used - type and placement) TYPE OF SURGERY: C1 - Conservative surgery - unilateral or bilateral, C2 - Conservative surgery with bilateral reduction (uni or bilateral), C3 - Conservative surgery with LD or LICAP/TDAP, C4 - Conservative surgery with bilateral breast augmentation, M1 - Mastectomy with unilateral reconstruction with implant, M2 - Mastectomy with unilateral reconstruction with autologous flap, M3 - Mastectomy with bilateral reconstruction with implants, M4 - Mastectomy with bilateral reconstruction with autologous flaps, M5 - Mastectomy with unilateral reconstruction with implant and contralateral symmetrisation with implant (augmentation), M6 - Mastectomy with unilateral reconstruction with implant and contralateral symmetrisation with reduction, M7 - Mastectomy with unilateral reconstruction with autologous flap and contralateral symmetrisation with reduction, M8 - Mastectomy with unilateral reconstruction with autologous flap and contralateral symmetrisation with implant (augmentation).

STATISTICAL ANALYSIS

An extensive descriptive analysis will be performed to characterize the groups in detail and the outcomes of the study at baseline as well as in the following points of data collection. Concerning the primary objectives, models of the class of generalized linear mixed models (in particular, multinomial regression models for ordinal data) will be estimated to evaluate the effect of the training and the women's characteristics on their evaluation of the aesthetic results of the surgery at each time and along time through longitudinal analysis. The Wilcoxon signed rank test for pairs will also be used to evaluate the effect of training on the level of agreement of the expectations and the final result. Weighted Cohen's k will be calculated for both groups (train and control) and compared using a statistical test and/or bootstrap techniques to assess the improvement in the ability to classify the aesthetic result of their surgery provided by training. A measure of similarity between self-evaluation and the BCCT.core will be computed for each participant, and a beta regression model will be estimated to assess the effect of training, controlling variables that can play as confounders, such as women's and disease characteristics at each time point and in a longitudinal perspective. Concerning the secondary objectives, the patient-reported outcome measures administered will be scored according to the official guidelines provided by the developers of the instruments. Besides the descriptive statistics, the outcomes will be compared between groups using adequate statistical tests. Again, models of the class of the general linear mixed models will be used.

Prospective randomized open trial with parallel groups

The solution we aim to apply in clinical practice is non-sex/gender specific. However, the proposal focuses on breast cancer, where there will be a predominance of female participants.

The incidence of breast cancer contrasts strikingly according to gender, with approximately 1% of all tumours occurring in males. Although breast conservation can also be offered to men, it is a rare practice, and most men are submitted to mastectomy without breast reconstruction.

As a consequence, it will be very difficult to recruit male patients to the study and obtain data that will allow any conclusions taking into account that mastectomy without reconstruction is out of our scope, and as such will not be included in our trial.

Comparing Decision on Aesthetics After Breast Cancer Locoregional Treatment.

Comparing Decision on Match of Expectations and Aesthetics Using a Conventional Versus a Cloud-based Healthcare Platform Approach in Breast Cancer Patients Proposed for Locoregional Treatment: A Prospective Randomized Trial

Agreement between patient's expectations about the aesthetic outcome measured before and after treatment, evaluated at 12 months after treatment (Cohen's Kappa and weighted Kappa Statistics) both the intervention and the control arm.

Agreement about the aesthetic outcome between the AI evaluation tool (BCT.core software) and self- evaluation after treatment (Cohen's Kappa and weighted Kappa Statistics) in both the intervention and the control arm.

Body image perception and satisfaction using the BREAST-Q ICHOM questionnaire. The scale scores from 0 lowest to 100 highest (body image satisfaction) in both the intervention and the control arm.

Resource consumption (cost per patient evaluated by the amount of appointments between the surgical proposal by the surgeon and the end of the trial) in both the intervention and control arm.

How results impact in patients general quality of life evaluated in both the intervention and control arm with the EQ-5D-5L questionnaire. The scale scores from 0 lowest to 100 highest. A high scale score represents a high/healthy level of functioning.

European Commission

INESC TEC - Institute for Systems and Computer Engineering, Technology and Science (Porto, Portugal)

Cankado GmbH

FCiências.ID - Associação para a Investigação e Desenvolvimento de Ciências (Lisbon, Portugal)

Bocconi University

Fundacao Champalimaud

Head Breast Surgeon - MD, PhD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical and Molecular Study With Digital Support of Patients With Inoperable Lung Cancer	NCT05372081	Non-Small Cell ...	Digital platfor...	18 Years -	Hellenic Cooperative Oncology Group
Clinical and Molecular Study With Digital Support of Patients With Inoperable Lung Cancer	NCT05372081	Non-Small Cell ...	Digital platfor...	18 Years -	Hellenic Cooperative Oncology Group
Clinical and Molecular Study With Digital Support of Patients With Inoperable Lung Cancer	NCT05372081	Non-Small Cell ...	Digital platfor...	18 Years -	Hellenic Cooperative Oncology Group
Comparing Decision on Aesthetics After Breast Cancer Locoregional Treatment.	NCT05196269	Breast Cancer	Artificial Inte...	18 Years -	Fundacao Champalimaud
Comparing Decision on Aesthetics After Breast Cancer Locoregional Treatment.	NCT05196269	Breast Cancer	Artificial Inte...	18 Years -	Fundacao Champalimaud
Clinical and Molecular Study With Digital Support of Patients With Inoperable Lung Cancer	NCT05372081	Non-Small Cell ...	Digital platfor...	18 Years -	Hellenic Cooperative Oncology Group

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