Clinical trials

Phase 1, monocentric, open labeled, no profit "Microdose" trial. A single microdose of the new \[68Ga\]Ga-R54 PET radiopharmaceutical directed against CXCR4 will be injected into patients with advanced solid tumor or multiple myeloma to evaluate the binding.

The investigators hypothesize that simvastatin (SIM) may improve the efficacy of first- line Nivolumab and Oxaliplatin-based chemotherapy, extending progression-free survival (PFS) as compared with Nivolumab and chemotherapy alone in patients with HER2 negative and ARID1A mutated advanced gastrooesophageal carcinoma (aGEC). Correlative mechanistic studies on tissue and blood samples, could help understanding the evolutionary dynamics of tumors in response to therapy thus optimizing the treatment approach and adding new insight into the antitumor mechanism of the combination approach.

This is a proof-of-concept, Open label, randomized, multicentric, superiority phase-2 study.

MITO END-4 is a prospective, single arm, multicentric phase II trial aiming to assess whether Inavolisib is effective in the treatment of advanced endometrial carcinoma with pathogenic PIK3CA mutation. Approximately 48 patients with PIK3CA mutation will be overall enrolled in the study.

MITO VULVA-1 is a prospective, single arm, multi-cohorts, phase II trial that aims to assess the activity and the safety of Lenvatinib plus Pembrolizumab in patients with vulvar cancer. 80 patients will be overall enrolled in the study.Three cohorts are planned

CAPTURE is a prospective, interventional, randomized, phase 2, double-blind, placebo-controlled study assessing the therapeutic add-on effect of the balanced THC/CBD extract (Cannabis extract Avextra 10/10 oral solution) on symptom burden in patients with advanced oncological disease receiving active treatment with WHO level II or III opioids and adjuvants therapies, compared to placebo, as measured by the Edmonton Symptom Assessment System Total Symptom Distress Score (ESAS-TSDS) at 8 weeks post randomization.

Non-profit, multicenter, prospective, observational study. This study aims to evaluate whether the articulated treatment algorithm that is now possible for early-stage breast cancer patients does produce tangible changes of financial distress over the time and whether the determinants of financial distress change their relative weight over the time.

The goal of this clinical trial is to learn if using artificial intelligence to guide intravenous fluid therapy during major cancer surgery can help keep blood pressure more stable compared with usual care in adult patients undergoing major cancer surgery. The main questions it aims to answer are: * Does artificial intelligence-guided fluid therapy reduce hypotensive events during surgery? * Does this approach improve recovery and reduce complications after major cancer surgery? Researchers will compare artificial intelligence-guided fluid therapy with standard fluid management to see if the artificial intelligence-guided approach provides better support during surgery. Participants will: * Undergo major cancer surgery under general anesthesia * Receive either artificial intelligence-guided fluid management or standard fluid management during surgery * Be monitored during and after surgery as part of routine clinical care * Be followed after surgery to assess recovery and possible complications

The investigators hypothesize that patients with mCRC RAS-mutant eligible for a second line treatment with good prognostic features, identified as single metastatic site, long progression free survival (PFS) in first line treatment, might benefit from a personalized approach, with less intensive treatment with regorafenib as part of a continuum-of-care strategy aimed at ensuring quality of life and extending survival.

The investigators hypothesize that the epigenetic agent valproic acid improve the activity of anti-EGFR agents, prevent and revert the emergence of EGFR resistance, in a rechallenge setting. Correlative mechanistic studies on tissue and blood samples, liquid biopsies, could identify potential biomarkers of efficacy and help understanding the evolutionary dynamics of tumors in response to therapy thus optimizing the treatment approach with a personalized anti- EGFR treatment strategy.

The present study is a retrospective-prospective observational and multicentric study aiming to collect data relating to all patients included in the ROC platform. All ROC centers will be involved in the present study.

This is multicentric, spontaneous, observational, retrospective and prospective study.

This is an observational, retrospective-prospective, multicentre trial enrolling all patients included in the AIFA monitoring registry of Dostarlimab for the indication in rectal cancer. The aims of the study are to describe the clinical outcomes and safety of patients with dMMR/MSI-H locally advanced rectal cancer (LARC) receiving neoadjuvant dostarlimab in the real-world setting.

Multicenter ambispective observational study (prospective/retrospective)

Prospective Multicenter Observational Study The study involves the consecutive inclusion of every patient with endometrial cancer undergoing staging surgical treatment using a robotic approach with the da Vinci SP platform.

This is a multicentric, retrospective, and prospective biomarker study.

In cancer patients, the integration between anticancer therapies and palliative care is of fundamental importance. In this context, telemedicine can improve the quality of life (QoL) of chronic patients through self-management and remote monitoring solutions. This approach can favor the effectiveness of the treatment and therapeutic adherence. Of note, telemedicine can also be applied to the management of cancer pain. In the advanced stages of cancer disease, pain is one of the most obvious and most disabling symptoms. Consequently, proper pain management has a significant impact on the QoL, the ability to withstand treatment, and the recovery of patients. On the other hand, given the complexity of cancer pain, the main obstacle to its proper management is the lack of adequate measurement methods. Although in recent years a great deal of effort has been made in the direction of automatic pain assessment, both concerning the creation of datasets and the development of classification algorithms, the literature is lacking regarding the automatic measurement of pain in the setting of cancer patients. Observation by experienced clinical staff and self-assessment by patients could be useful for obtaining the ground truth and, in turn, for training automatic pain recognition systems.

This is an observational, prospective study enrolling patients who meet the inclusion criteria and provide consent for the use of biopsy samples collected as part of standard clinical practice. The analysis will focus on the following biomarkers: TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, and ERCC1. These biomarkers will be examined in both observation groups.

Tumor Antigen Discovery for Innovative Cancer Immunotherapies in HCC: From Benchside to Bedside (HepAnt) - Study of the Role of the Metagenome in Head and Neck Tumors Using Omics Techniques (HeNomics).

This is a multicenter, non-pharmacological, experimental, prospective, randomized study, with two arms (1:1) in a single-blind design. The study aims to evaluate the effectiveness of a tele-consultation procedure in patients undergoing elective colonoscopy in terms of quality of the exam, anxiety procedure-related and financial toxicity.

The INNOVA project aims to create an advanced multidisciplinary diagnostic platform to support the Italian healthcare system and translational research. In this context, WP7, coordinated by the Pascale Institute and the focus of this study protocol, is responsible for developing a national platform for the multi-omic profiling of cancer patients eligible for precision medicine treatments, with the goal of supporting clinical decision-making.

COESIT aims to establish a network of reference laboratories in the central-southern regions of Italy for the genetic and molecular characterization of tumors, with the goal of implementing precision and personalized oncology in clinical practice.

The study involves the use of reagents or materials for diagnostic assessments that are not commercially available, specifically a metabolomic signature for screening endometrial carcinoma and/or other types of cancers, and follows a case-control design. This study aims to achieve several objectives that contribute to evaluating the diagnostic potential of a specific "metabolomic signature" to be used for screening endometrial carcinoma. Specifically, the study seeks to assess the signature's discriminative ability in differentiating between benign endometrial neoplasms and neoplasms of different histological origins.

The incidence of colorectal cancer (CRC) is higher in patients with chronic kidney disease (CKD) compared to general population. Causal factors have not been clarified so far, although some hypothesis could be formulated. Tumor microenvironment (TME) impacts cancer progression and is influenced by different chronic diseases associated with systemic inflammation. In our study, we aim to address this relevant issue by an in-deep characterization of TME in CKD patients with CRC undergoing surgery. This will provide genes expression directly on tumor tissues. Our network includes three high national relevance hospitals (INT IRCCS Pascale, AOU Vanvitelli and AOU Brotzu) and a Genetic Research Institute (Biogem Scarl). We will recruit two comparing groups of CRC patients eligible for surgical cancer resection: 1. Patients with I-II stage CRC alone, and 2. Patients with I-II stage CRC and CKD. Anthropological, clinical and laboratory tests data will be collected and organized in a database for epidemiological and descriptive analysis of the enrolled cohorts. Patients will be matched by age, gender and cancer stage and will be stratified by the estimated renal function (application of BSA eGFR formula by Janovitz T et al, J Clin Oncol, 2017). Patients will undergo preoperative high resolution abdominal MRI for high throughput accurate macroscopic assessment of TME by radiomic approach. During surgery, tumor tissue samples will be collected and promptly frozen at -80°C for subsequent analysis. CRC tissue samples will be analyzed combining spatially resolved and single-cell transcriptomic approach, providing a sensitive and unbiased lens for identifying the key mechanisms of the interplay between CRC and immune context, preserving their tissue architecture. Our study involves the usage of Visium Cytassist Spatial Gene Expression, a powerful tool based on in situ capturing methods, providing the whole transcriptome information from tissue sections. Data collected by radiomics and tissue transcriptomics will undergo integrated analysis by a bioinformatic approach based on computational methods. TME will be macroscopically characterized on tumor images to map specific tissue areas of interest. By spatial tumor sections analysis, initial segregation of non-malignant TME cells from malignant ones will be performed and then the identification of differentially expressed genes and pathways between the two groups of patients will be finalized. These methodologies will allow the full characterization of CRC environment and will highlight possible differences between groups in TME macroscopic imaging features and gene expression. This will permit the discovery of possible specific tumor imaging-detected patterns and the associated molecular pathways specially promoted or deregulated in CKD patients with CRC. These evidences will enhance the value of possible prognostic parameters and the identification of early biomarkers of CRC and future development of targeted therapies. In the era of precision medicine, these goals appear relevant to address the increasing cost and social impact of both CRC and CKD.

Neoadjuvant chemo- and immunotherapy ameliorate the recurrence rate of cholangiocarcinoma (CCA) at 12 months after surgery.