Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Primary Liver Cancer

Hematinics

All Drugs and Chemicals

Liver Extracts

Participants with new diagnosis of liver cancer, from whom blood samples will be collected.

Participants with benign diseases of cancer, from whom blood samples will be collected.

Participants without known presence of malignancies or benign diseases of liver, from whom blood samples will be collected.

Participants with new diagnosis of interfering cancer types, from whom blood samples will be collected.

Blood collection and liver-cancer early detection test

Liver-cancer early detection test

Bo Liu

Shangli Cai

Lanqing Yao

Tian Yang

Nanya Wang

In the recently published multi-center, prospective, single-blind study (THUNDER study), using the methylation signal in cfDNA isolated from the peripheral blood to detect the six types of cancer, the sensitivity for liver cancer detection achieved 87.8%, with a specificity of 98.9%. In this study, a multicenter, case-control study is designed to establish an early cancer detection model based on cfDNA methylation biomarkers using qPCR to detect primary liver cancer and further validate the performance of the model.

Primary Liver Cancer Early Detection

Early Detection of Primary Liver Cancer Based on cfDNA Methylation: A Multi-Center Case-Control Study (PRIMe-liver)

Sensitivity and specificity of liver cancer detection model based on selected cfDNA methylation biomarkers using qPCR in subjects with primary liver cancer or benign liver diseases, interfering cancers and healthy individuals

Sensitivity of the liver cancer early detection model in patients with small liver cancer lesions or AFP negative

Sensitivity of the liver cancer early detection model in different stages or different pathological subtypes

Specificity of the liver cancer early detection model to differentiate patients with benign liver diseases or different interfering cancer types from liver cancer

Comparison of the sensitivity and specificity of the liver cancer early detection model and other biomarkers of liver cancer in detecting early liver cancer

Guangzhou Burning Rock Dx Co., Ltd.

The First Hospital of Jilin University

Professor of Gastroenterology & Hepatology

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gastrointestinal Agents

Pancrelipase

Pancreatin

Pancreatic cancer patients evaluated at the Pancreatic Surgery Unit of the Pancreas Institute of the University of Verona will be enrolled. Fifteen PC patients per stage will be selected (15 Stage I/II, Stage III, Stage IV). Patients may have been scheduled for surgery or for biopsy for future systemic treatments. An oral microbiota (dental plaque) sample will be collected and a periodontal and dental assessment will be performed, before any therapeutic procedure, together with orthopantomography

Age-matched (+- 5 years) healthy controls referring to the Odontostomatology Unit for oral procedure according to clinical practice, with a recent (not longer than 12 months) cross-sectional abdominal imaging excluding gastrointestinal cancers.

Pancreatic cancer patients evaluated at the Pancreatic Surgery Unit of the Pancreas Institute of the University of Verona will be enrolled. Fifteen PC patients per stage will be selected (15 Stage I/II, Stage III, Stage IV). Patients may have been scheduled for surgery or for biopsy for future systemic treatments.

Patients suffering from IPMNs evaluated at outpatients clinics or scheduled for surgery.

Dental plaque sampling

qPCR

Salvatore Paiella, MD, PhD

Erica Secchettin, PharmD

Salvatore Paiella

Erica Secchettin

Francesca Zotti

Pancreatic cancer (PC) is a solid malignancy with a dismal prognosis. It has a 5-year survival rate of approximately 8%. This is due to the usually late diagnosis, to chemoresistance, and to intrinsic biological aggressiveness. Risk factors for PC are smoking, alcohol, chronic pancreatitis, obesity, and diabetes. Recently, research has been dedicated to the identification of a causal connection between certain pathogenic microorganisms, especially of the oral flora, and PC. This would ultimately allow to identify new biomarkers to adopt for early diagnosis, or to create new strategies for prevention.

Oral microbiota, periodontal disease and neoplastic risk

When referring to "oral microbiota" (OM), about 700 hundreds bacterial species are mentioned, colonizing the oral cavity. A change in the normal flora of the oral cavity is commonly indicated with the term "dysbiosis".

The causal connection between oral microbiota, periodontal disease and neoplastic risk is possibly triple. First, it has been found that oral flora substantially differentiates between cancer patients and controls. In particular, the most predominant phyla in cancer patients are Firmicutes and Actinobacteria, whereas Proteobacteria, Fusobacteria, and Bacteroides are more common in healthy controls. This highlights the possibility of a direct causal connection between dysbiosis and neoplastic risk. Second, oral dysbiosis represents the main risk factor of PD that per sé is a risk factor of many cancers. Third, the conditions leading to oral dysbiosis (alcohol, smoking, obesity, diabetes, chronic drugs intake, dietary habits, etc.) are the most well known risk factors either for cancer and oral dysbiosis. The common denominator is always represented by chronic inflammation and migration of microorganisms to distant sites, ultimately promoting neoplastic progression.

This tangled net of causal connections sheds light on the potential important role of the oral cavity and PD as independent risk factors for many cancers, and as modifiable elements to reduce the neoplastic risk and to perform prevention(15).

Oral microbiota, periodontal disease and pancreatic cancer

In 2012, the pioneering study by Farrell et al. showed that bacteria of the OM can discriminate PC patients from healthy subjects. Since then, few other studies have shown that changes of the OM are independent risk factors for PC and that the OM of PC patients differs than controls. The involved bacterial species are many and their role seems to be contrasting on the basis of the study considered. Farrell et al. found that the combined adoption of Neisseria elongata and Streptococcus mitis distinguished PC patients from healthy controls (both showed low levels in PC patients, AUC of combined sensitivity 0.9), and that higher levels of Granulicatella adiacens and Streptococcus Mitis distinguished PC patients from chronic pancreatitis ones. Torres et al. found a higher ratio of Leptotrichia to Porphyromonas in PC patients. Fan et al. reported that Porphyromonas gingivalis, Prevotella intermedia, Alloprevotella and Aggregatibacter actinomycetemcomitans are associated with a higher risk of PC, whereas Fusobacteria and Leptotrichia were associated with a decreased risk. Another study evaluating the diversity of OM in three groups of individuals (PC patients, patients suffering from Intraductal papillary mucinous neoplasms \[a pancreatic preneoplastic condition\], and healthy controls), excluding current smokers and users of antibiotics, found no differences in the OM, although patients with PC had a higher proportion of Firmicutes compared with Intraductal Papillary Mucinous Neoplasms (IPMNs) and controls. Lastly, a recent study by Gaiser et al. showed that the cystic fluid of patients submitted to surgery for IPMNs contained bacterial species that are commonly found in the oral cavity, including, among the others, Granulicatella adiacens, Fusobacterium nucleatum. These two, in particular, were higher in the cohort of individuals with IPMNs with high-grade dysplasia, indicating a pivotal role in tumorigenesis(19).

As regards PD, the first studies demonstrating an association between PD and PC date back to the mid of 2000's, and they were confirmed afterward, even adjusting confounders such as diabetes, pancreatitis, hyperlipemia, smoking or alcohol-related conditions. PD is strictly connected to oral hygiene, that seems to be associated to an increased risk of PC. It is now clear that PD can concur to development of PC in several ways, promoting chronic inflammation, spreading continuously to distant organs (including pancreas) pro-tumorigenic bacteria, or promoting a chronic alteration of the immune function that make the individual more prone to develop a cancer.

Pancreatic Cancer and Oral Microbiome

Pancreatic canceR pErioDontAl sTatus and Oral micRobiome - PREDATOR Study

According to the periodontal status (appropriate scores will be used), patients will be divided into distinct groups. The proportional means of abundance of selected genera and species, and bacterial load (real-time data) between these groups will be analyzed using the Mann-Whitney U-test. Correlations between mean distributions of the genera and species and the parodontal status scores values will be analysed using the Spearman Correlation Coefficient.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Primary Liver Cancer Early Detection	NCT05996666	Liver Cancer	Liver-cancer ea...	18 Years - 74 Years	The First Hospital of Jilin University
Pancreatic Cancer and Oral Microbiome	NCT04993846	Oral Microbiome Pancreatic Canc... IPMN Parodontopathy	Dental plaque s... qPCR	18 Years - 75 Years	Azienda Ospedaliera Universitaria Integrata Verona

Spots Global Cancer Trial Database for qpcr

Every month we try and update this database with for qpcr cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for qpcr

Every month we try and update this database with for qpcr cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for qpcr cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.