Neoplasms

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Rare Diseases

Head and Neck Neoplasms

Sarcopenia

Atrophy

Muscular Atrophy

Neuromuscular Manifestations

Neurologic Manifestations

Pathological Conditions, Anatomical

Acute Graft Versus Host Disease

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Chrysarobin

the patient is administered with questionnaires focused on diet, fatigue, nutrition screening and on body mass index at the beginning and at the end pf particle therapy radiation treatment

questionnaires QLQ-FA12, Mini Nutritional Assessment Short Form, Nutritional Risk Screening, diet questionnaire of frequency, ,body mass index measurement

as per clinical routine, hemoglobin, lymphocytes, albumin and NLR will be collected

blood biomarkers

Rossana Ingargiola, MD

Cristina Bono, MSc

The study focuses on the impact of sarcopenia on acute and late toxicities in head and neck tumor affected patients treated with particle therapy.

To evaluate in HNC patients treated with particle therapy the impact of SP (measured by low skeletal muscle mass at the C3 vertebral body) on toxicity profile assessed according to NCI's Common Terminology Criteria for Adverse Events CTCAE (version 5.0), defined as:

* Acute toxicity: within 3 months from the beginning of particle RT
* Late toxicity: more than 6 months after the end of particle RT. To investigate possible association between SP and nutritional

Sarcopenia in Head and Neck Cancer Patients Treated With Curative Hadrontherapy

Role of Baseline Sarcopenia in Determining Acute Toxicity for Head and Neck Cancer Patients Treated With Curative Hadrontherapy: a Prospective Monoinstitutional Study

measurement of sarcopenia to evaluate the development of the affection

CNAO National Center of Oncological Hadrontherapy

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

Amino Acids

Immune Checkpoint Inhibitors

Angiogenesis Inhibitors

Immunomodulating Agents

Tyrosine Kinase Inhibitors

Tyrosine

Therapeutic combination tyrosine kinase inhibitor (TKI) + immune checkpoint inhibitors (ICI)

Therapeutic combination with different immune checkpoint inhibitors (ICI)

Systematic extra blood sampling at inclusion, 6 weeks after inclusion and in case of progression of the cancer

Blood collection

reuse of tumour tissue collect in usual patient care

Tumour samples

Natacha Nohilé

Laetitia MAUGE, PharmD, PhD

Marie AUVRAY-KUNITZ, MD

Olivier HUILLARD, MD

Olivier HUILLARD, MD, PhD

This is a multicenter, exploratory, prospective study to identify angiogenesis and immune-related biomarkers predictive of progression free survival in patients with metastatic or advanced renal cell carcinoma treated by a combination of immunotherapy and antiangiogenic.

Recently, the management of renal cell carcinoma has undergone major changes with the emergence of combined therapies associating tyrosine kinase inhibitors (TKI) and immune checkpoint inhibitors (ICI) as first line treatments. However, there are no criteria to guide the choice between the different combinations validated and or between ICI combinations. Angiogenesis and immunity are intimately linked and some markers related have could be interesting to predict the efficacy of these combinations. Angiogenesis and immunity are highly related. This link may lead to new biomarkers to be explored to predict the response to TKI + ICI therapy combinations. On this basis, the investigators propose to conduct an open-label exploratory, multicenter prospective trial to study the association between angiogenesis and immune markers and the effect of combined TKI+ICI treatments.

Biomarkers of Angiogenesis for Response to Therapeutic Combination in Advanced or Metastatic Kidney Cancer

Predictive Role of Circulating Biomarkers Involved in Angiogenesis in Metastatic Kidney Cancer in the Era of New Therapeutic Associations: Immunotherapies, Anti-angiogenic

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

Time from inclusion to progression documented by imaging and based on RECIST 1.1 and iRECIST criteria or patient death. The iRECIST criteria use the same methods of monitoring tumor lesions as the RECIST 1.1 criteria but a confirmation 4-6 weeks after suspicion of progression is required to confirm or rule out progression because patients undergoing immunotherapy may present pseudo-progressions.

Observation of a partial or complete response according to RECIST 1.1 criteria during the follow-up

Time between the observation of an objective response (partial or complete according to RECIST 1.1 criteria) and the progression

Institut National de la Santé Et de la Recherche Médicale, France

FONCER contre le cancer

Assistance Publique - Hôpitaux de Paris

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

LDCT screening volunteers enrolled in the BioMILD trial (clinicaltrial.gov NCT02247453) with solid and sub-solid baseline LDCT lung nodules, including baseline-identified cancer patients.

LDCT screening volunteers enrolled in the SMILE trial (clinicaltrial.gov NCT03654105) and in the RISP trial (clinicaltrial.gov NCT05766046).

Combining blood-based biomarkers, radiologic parameters, clinical features, and AI tools to create a robust model to predict lung cancer risk.

Artificial Intelligence risk model

Ugo Pastorino, MD

Low-dose computed tomography (LDCT) lung cancer (LC) screening can reduce mortality among heavy smokers, but there is a critical need to better identify people at higher risk and to reduce harms related to management of benign nodules. The most promising strategy is to combine novel tools to optimize clinical decisions and increase the benefit of screening.

In this respect, the investigators already demonstrated that the combination of baseline LDCT features with a minimal invasive microRNA blood test was able to more precisely estimate the individual risk of developing LC. The investigators posit that additional immune-related and radiologic features can be integrated with the help of artificial intelligence (AI) to further implement LDCT screening strategies. The project will answer whether the combination of (bio)markers of different origin can predict LC development at baseline and over time, indicate which screen-detected lung nodules are likely to be malignant and ultimately reduce LC and all cause mortality.

Lung cancer constitutes 28% of all cancer deaths in Europe, with 70% of patients diagnosed at advanced stages and a mere 21% 5-year survival rate. Despite smoking's causative link to almost 90% of cases, global smoking rates persist, posing a long-term public health challenge. Our focus lies in refining lung cancer risk assessment using blood-based biomarkers, particularly circulating microRNAs (miRNAs) and C-reactive protein. Biennial LDCT screenings and blood tests predicting lung cancer risk have shown effectiveness, as seen in our pioneering work within the BioMILD trial since 2013.

The BioMILD trial, encompassing 4119 volunteers, combines LDCT and microRNA biomarkers, demonstrating feasibility and safety over 4 years. Our current endeavor aims to develop a predictive model for LDCT-detected high-risk lung nodules, incorporating blood, functional, and radiomics biomarkers. Leveraging the BioMILD trial's biorepository, imaging database, and 20 patient-derived xenografts (PDXs), the investigators utilize advanced artificial intelligence (AI) tools for comprehensive analysis. This approach, involving 400 subjects with solid and sub-solid LDCT lung nodules, including 100 baseline-identified cancer patients, is crucial.

By combining blood-based biomarkers, radiologic parameters, clinical features, and AI tools, the investigators aim to create a robust model. This model will be validated using an independent set of 100 subjects (25 with and 75 without lung cancer) from the ongoing SMILE screening trial. If successful, our vision is to prospectively implement this panel in clinical contexts where it proves beneficial. Our mission is to reduce lung cancer mortality, optimizing screening interventions with novel, non-invasive tools for all high-risk individuals while minimizing costs and radiation exposure-related harms.

Aim 1 Assessment of an Immune Signature Classifier (ISC) on peripheral blood mononuclear cell (PBMC) samples collected from screen detected solid and sub-solid LDCT lung nodules and integration of ISC with existing biomarkers such as the MSC test and the c-Reactive Protein (cRP).

Aim 2 Evaluation of radiologic features and other LDCT markers related to respiratory and cardiovascular disorders.

Aim 3 Development of a risk classifier using AI tools based on combination of blood biomarkers, imaging and clinical data to improve LDCT screening sensitivity and positive predictive value.

AI for Lung Cancer Risk Definition in Computed Tomography Screening Programs

Artificial Intelligence Tools Integrating Blood Biomarkers and Radiomics to Define Lung Cancer Risk in Computed Tomography Screening Programs

Development of a risk classifier using AI tools based on combination of blood biomarkers, imaging and clinical data to improve LDCT screening sensitivity and positive predictive value.

Evaluation of radiologic features and other LDCT markers related to respiratory and cardiovascular disorders.

Assessment of an Immune Signature Classifier (ISC) on peripheral blood mononuclear cell (PBMC) samples collected from screen detected solid and sub-solid LDCT lung nodules and integration of ISC with existing biomarkers such as the MSC test and the c-Reactive Protein (cRP).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sarcopenia in Head and Neck Cancer Patients Treated With Curative Hadrontherapy	NCT06207708	Head and Neck C...	questionnaires ... blood biomarker...	18 Years -	CNAO National Center of Oncological Hadrontherapy
Biomarkers of Angiogenesis for Response to Therapeutic Combination in Advanced or Metastatic Kidney Cancer	NCT05285579	Renal Cell Carc... Renal Cancer Renal Cancer Me...	Blood collectio... Tumour samples	18 Years -	Assistance Publique - Hôpitaux de Paris
AI for Lung Cancer Risk Definition in Computed Tomography Screening Programs	NCT06320184	Lung Cancer Blood Biomarker...	Artificial Inte...	50 Years - 75 Years	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sarcopenia in Head and Neck Cancer Patients Treated With Curative Hadrontherapy	NCT06207708	Head and Neck C...	questionnaires ... blood biomarker...	18 Years -	CNAO National Center of Oncological Hadrontherapy

Spots Global Cancer Trial Database for blood biomarkers