Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Primary Liver Cancer

Oculocerebral Syndrome With Hypopigmentation

Hematinics

All Drugs and Chemicals

Liver Extracts

Investigation of postoperative symptoms in eligible patients undergoing liver resection at two time points

Observational study, focusing solely on symptom surveys of patients.

postoperative symptoms

shuwen M Li, PhD

Patients with primary liver cancer (PLC) experience a range of symptoms in the early postoperative period. Symptoms include cancer-related symptoms and adverse effects of treatment. Exploring the core symptoms and their dynamics in the early post-hepatectomy patients may help provide better symptom management programs. The purpose of this study was to identify the core symptoms in early post-hepatectomy patients and to explore the trajectory of their dynamics. During the period from March 2021 to September 2022, a total of 281 patients diagnosed with PLC and undergoing radical curative surgery were recruited from the hepatobiliary surgery departments of two hospitals in Eastern China, among whom 249 individuals (88.60%) agreed to participate in the study. A comprehensive symptom assessment was administered to the patients 1-2 days after surgery (T1) and 1-2 days before discharge (T2). Network analysis was used to identify core symptoms in early post-hepatectomy patients based on symptom severity.

Postoperative Symptoms in Chinese Liver Cancer Patients: Network Analysis

Exploring Early Postoperative Core Symptoms in Chinese Patients With Primary Liver Cancer: a Cross-sectional and Longitudinal Network Analysis

We do not plan to share individual participant data (Share IPD) to protect participant privacy. However, individuals who support the findings of this study may contact the study's principal investigator directly to request data.

The MD Anderson Symptom Inventory (MDASI) is one of the most widely used symptom assessment tools for cancer patients in clinical and research settings and is used to evaluate the severity of symptoms and their impact on daily life. It consists of 13 core symptom items and 6 symptom interference items. The severity of each symptom is rated on an 11-point Likert scale (0 = "not at all" and 10 = "as bad as you can imagine"). The MDASI-C, a Chinese version translated in 2004 by Wang et al., has good reliability, with a Cronbach's alpha of 0.82-0.94.

The Symptom Module Specific for Primary Liver Cancer (TSM-PLC) can serve as an important supplement to the MDASI, providing instrumental security for the systematic assessment of symptoms in patients PLC. It consists of six symptom items: abdominal distension, diarrhea, loss of weight, jaundice, pruritus, and fever. The six items were rated in the same format as the first part of the MDASI. The TSM-PLC has good reliability (Cronbach's alpha of 0.835 for internal consistency and content validity of 0.91).

Anhui Medical University

Mengmeng Yuan

Research Assistant

Skin and Connective Tissue Diseases

Diseases and Abnormalities at or Before Birth

Breast Neoplasms

Congenital Abnormalities

Breast Diseases

Skin Diseases

Participants will be offered:

1. Liquid biopsy of ctDNA and targeted NGS (BRCA1, BRCA2, CHEK2, PALB2, BRIP1, TP53, PTEN, STK11, CDH1, ATM, BARD1, MLH1, MRE11A, MSH2, MSH6, MUTYH, NBN, PMS1, PMS2, RAD50, RAD51C, RAD51D, NF1, EPCAM, SMARCA4, CDK12);
2. Whole-genome RRBS

Participants will not be offered targeted NGS or whole-genome RRBS but will receive their usual clinical care

Next Generation Sequencing and Network Analysis will profile genetic and epigenetic abnormalities in blood from patients with BC.

Next Generation Sequencing and Network Analysis

Giuditta Benincasa, PhD

The standard tissue biopsy strategy for cancer detection is not comprehensive enough to profile the whole epi-genomic signatures of breast cancer (BC) and ensure an accurate prognosis and prediction of drug response. Liquid-based assays have the potential to reduce the molecular heterogeneity of BC and a possible utility for improving disease management. In particular, genomic DNA (gDNA) and circulating tumor (ctDNA) can be sequenced for genetic and epigenetic (DNA methylation) profiling of the BC patients to enhance personalized prognosis and prediction of drug therapy. We describe a study protocol for evaluating the clinical utility of the early use of the network-oriented BR(E)2ASTOME algorithm which combine the power of liquid-based assays, advanced epi-genomics platform, and network analysis to identify improve precision medicine and personalized therapy of BC.

The BR(E)2ASTOME study will be performed at the U.O.C. Patologia Molecolare e Clinica, University of Campania "L. Vanvitelli", Naples (Italy) with a long-standing experience in diagnosis and treatment of BC (Refs.). From each study participant, total of 10 mL of pheripheral blood in EDTA tubes will be collected at time of BC diagnosis. Blood-based assays will be performed to obtain genetic and/or epigenetic big data from ct-DNA and gDNA, respectively. A network-oriented algorithm combined with patient-level clinical information will be applied to big data in order to identify clusters of genes (BC-modules) harboring novel genetic mutations, in the NGS-ctDNA BC-group, and differentially methylated regions (DMRs), in the RRBS-gDNA group, with a potential predictive and prognostic role in BC management. In the NGS-ctDNA-RRBS-gDNA group, we will evaluate whether the multi-omics approach is more informative as compared to the single-omic paradigm.

BC patients (males and females) will be randomized to the 2 study arms: ctDNA-NGS + gDNA-RRBS, and standard of care alone. No modifications of intervention assignment will be possible after randomization process of patients. The BR(E)2ASTOME study will provide evidence about the potential clinical utility of early use liquid-based assays and network-oriented biomarkers in prognosis and prediction of drug response in BC management.

Thus, results from BR(E)2ASTOME study will bring to identify not only new molecular mechanisms associated with BC, but also non-invasive biomarkers that can direct towards an early diagnosis, contribute to monitor the cancer progression and the response to therapeutic treatment.

Breast Cancer, Omics, and Precision Medicine

Evaluating the Predictive and Prognostic Power of the Early Breast canceR gEnetic and Epigenetic Abnormalities Through Liquid biopSy and neTwOrk MEdicine Algorithm: the BR(E)2ASTOME Phase II Randomized Controlled Trial

We will evaluate whether the network-oriented BR(E)2ASTOME approach will identify BC modules useful for a better stratification of BC severity.

We will measure:

DNA methylation levels and associations with clinical parameters (survival, hospitalization, all-cause mortality).

We will evaluate potential novel genetic mutations in targeted genes and associations with clinical parameters (survival, rate of hospitalization, all-cause mortality)

We will evaluate whether the network-oriented BR(E)2ASTOME approach will identify BC modules useful for predicting the individual drug response.

We will measure DNA methylation levels, and potential novel genetic mutations, and their association with clinical parameters (poor/good response to drug therapy).

University of Campania "Luigi Vanvitelli"

Principal Investigator

Infections

Blood and Lymph Conditions

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Leukemia

Communicable Diseases

COVID-19

Hematologic Neoplasms

Disease Attributes

Hematologic Diseases

Pneumonia

Pneumonia, Viral

Respiratory Tract Infections

Virus Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung Diseases

Respiratory Tract Diseases

Patients with SARS-CoV-2 positive hematologic tumors over 18 years old excluding patients with severe diseases associated with other systems.

People with SARS-CoV-2 positive without underlying diseases over 18 years old excluding people with severe diseases associated with other systems.

None intervention

The goal of this observational study is to compare the immune function and infection mechanism of patients with hematologic tumors and those people without underlying diseases after infection with SARS-CoV-2. Clinical characteristics, treatment options and responses will be collected. Peripheral blood will be collected from patients with hematologic tumors infected with SARS-CoV-2 and those people without underlying diseases infected with SARS-CoV-2.

To establish a retrospective and prospective cohort of patients with hematologic tumors infected with SARS-CoV-2 and people without underlying diseases infected with SARS-CoV-2. Firstly, peripheral blood samples will be collected at infection time points and after SARS-CoV-2 nucleic acid testing turns negative. Subsequently, the transcriptome sequencing and immunological experiments will be performed to analyze the differentially expressed genes, immune function of cells, etc.

Comparative analysis:

1. To compare the immune function of patients with hematologic tumors and those without underlying diseases after infection with SARS-CoV-2.
2. The transcriptomic and proteomic changes of patients with hematologic tumors are compared with those without underlying diseases after infection with SARS-CoV-2.
3. From the perspective of complex (human protein interaction subnetwork), the dynamic change process of SARS-CoV-2-targeted human protein complex (periodic complex) was deeply explored, in order to further analyze its potential dynamic infection mechanism and provide new clues for the discovery of drug targets.

Peripheral blood mononuclear cells are extracted to perform RNA-sequencing.

Mechanism and Immune Function Analysis of SARS-CoV-2 Infection in Hematologic Tumors

Mechanism and Immune Function Analysis of SARS-CoV-2 Infection in Hematologic Tumors and Discovery of Potential Drug Targets

To compare the infection mechanism and immune function of patients with hematologic tumors infected with SARS-CoV-2 and people infected with SARS-CoV-2 without underlying diseases.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Postoperative Symptoms in Chinese Liver Cancer Patients: Network Analysis	NCT06419478	Patients With P... Importance of I... Application of ...	postoperative s...	40 Years - 90 Years	Anhui Medical University
Breast Cancer, Omics, and Precision Medicine	NCT04996836	Breast Cancer	Next Generation...	18 Years -	University of Campania "Luigi Vanvitelli"
Breast Cancer, Omics, and Precision Medicine	NCT04996836	Breast Cancer	Next Generation...	18 Years -	University of Campania "Luigi Vanvitelli"
Mechanism and Immune Function Analysis of SARS-CoV-2 Infection in Hematologic Tumors	NCT05683353	SARS-CoV-2 Infe... Hematologic Mal...	None interventi...	18 Years -	Peking University First Hospital

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