Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hepatocellular carcinoma (HCC) is the most common form of liver cancer and its incidence is increasing including in regions where hepatitis infection rates are low. This trend may be the result of increases in 'unhealthy lifestyle' factors. The main aim of this study is to identify metabolic signatures associated with healthy lifestyle behaviours and to relate these signatures to risk of developing HCC to investigate whether the metabolites were of predictive utility for HCC beyond data procured from questionnaires. To address this question, we exploited data from a large European cohort (EPIC) which includes detailed questionnaire-based data as well as metabolomic data.

Studies using metabolomic data have identified metabolites from several compound classes that are associated with disease-related lifestyle factors. This study identified metabolic signatures reflecting lifestyle patterns and related them to hepatocellular carcinoma (HCC) risk in the EPIC cohort. Partial Least Squares (PLS) analysis related seven modified Healthy Lifestyle Index variables (diet, BMI, physical activity, lifetime alcohol, smoking, diabetes, hepatitis) to 132 targeted serum-measured metabolites, and a liver function score in a nested study of HCC with 147 case-control pairs. The association between the resulting PLS scores and HCC risk was examined in multivariable conditional logistic regression models where odds ratios (OR) and their 95% confidence intervals (95%CI) were computed. The PLS-derived lifestyle component reflected a high propensity towards healthy behaviours. Its metabolic counterpart was positively related to the following metabolites: SM(OH) C14:1, C16:1 and C22:2, and negatively to glutamate, hexoses, and PC aaC32:1. The lifestyle and metabolomics components were inversely associated with HCC risk with OR for a 1-SD increase in scores equal to 0.49(95%CI=0.35 to 0.68) and 0.28(0.18 to 0.43).

Measuring a specific metabolites panel may identify strata of the population at higher risk for HCC and can add substantial discrimination compared to questionnaire data

Metabolic Signature of Healthy Lifestyle and HCC

Metabolic Signature of Healthy Lifestyle and Its Relationship With Risk of Hepatocellular Carcinoma in a Large European Cohort

Incident HCC cases were defined as first primary invasive tumours and identified through the 10th Revision of International Statistical Classification of Diseases, Injury and Causes of Death (ICD10) as C22.0 with morphology codes ICD-O-2 "8170/3"and "8180/3"

Imperial College London

Danish Cancer Society

University of Aarhus

Centre for Research in Epidemiology and Population Health (CESP)

Gustave Roussy, Cancer Campus, Grand Paris

German Cancer Research Center

German Institute of Human Nutrition

Hellenic Health Foundation

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

ISPO Cancer Prevention and Research Institute

Federico II University

HuGeF Foundation

Azienda Sanitaria Provinciale Ragusa

University of Tromso

Catalan Institute of Oncology, Barcelona

Ministry of Health - Government of the Principality of Asturias

Andalusian School of Public Health

Universidad de Murcia

Instituto de Salud Pública Gobierno de Navarra

Subdirección de Salud Pública de Gipuzkoa

Skane University Hospital

Umeå University

MORGEN-EPIC, Bilthoven

Prospect-EPIC, Utrecht

University of Oxford

University of Cambridge

International Agency for Research on Cancer

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Postoperative Complications

Head and Neck Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Urologic Diseases

All Drugs and Chemicals

Psychotropic Drugs

Imidacloprid

Bupropion

Nicotine

Varenicline

The study intervention consists of a smoking cessation counselling meeting by a Tabacco Treatment Specialist (TSS) 4 weeks before surgery. The goal of this first intervention meeting is to implement an individual treatment plan for preoperative smoking cessation.

Patients randomised to the control arm will get advice only. Their preoperative course will be as if they were not participating in this study, meaning they will receive inconsistent perioperative smoking cessation advice from nurses, surgeons, or anaesthesiologists but no further study-specific smoking cessation intervention. Importantly, participants in the control group will not be discouraged from using perioperative smoking cessation aids and can still obtain help on one's own initiative.

The study intervention consists of an interview by a Tabacco Treatment Specialist (TSS) 4 weeks before surgery with individual counselling and offered nicotine substitution. The intervention meeting is based on the Chronic Care Model (CCM) to improve quality of ambulatory care.

In brief, the intervention includes:

* Informative content about advantages of smoking cessation
* Scheduling service for a motivational interview by a TSS in office to implement a treatment plan
* For participants willing to quit smoking a preoperative quit day will be scheduled after the first intervention meeting 2-3 weeks before surgery
* Patients will be encouraged by a TSS to use nicotine replacement. Bupropion or Vareniclin will be provided on an individual basis
* TSS will schedule repeated follow-up meetings to support smoking abstinence or nicotine reduction before and after surgery for all patients

Intensive preoperative smoking cessation counselling

Studienkoordination Tumorzentrum

Christian Fankhauser, PD Dr. med.

Background: At present, effectively implementing smoking cessation programs in the health care system constitutes a major challenge. A unique opportunity to initiate smoking cessation focuses on smokers scheduled for surgery. These patients are not only highly motivated to quit smoking but also likely to benefit from a reduction in postoperative complications which may translate into a decrease of costs. Nevertheless, surgical patients are not routinely informed about the benefits of preoperative smoking cessation. Potential reasons for this missed opportunity may be lack of time and training of surgeons and anesthesiologists. The investigators therefore aim to analyse the impact of a preoperative high-intensity smoking cessation intervention on surgical complications up to a 90-day postoperative period in patients of various surgical disciplines. The hypothesis is that preoperative smoking cessation program improves outcomes in smokers undergoing intermediate to high-risk surgery. The primary objective is to compare complications between patients with an institutional multifaceted smoking cessation intervention starting four weeks before surgery compared to patients in the advice only group (control group) within a 90-day postoperative period. The primary endpoint is the Comprehensive Complication Index (CCI®) within 90 days of surgery. Secondary outcomes include length of hospital stay, cost of hospital stay, smoking abstinence, reduction in nicotine consumption.

Methods: The present study is a single center, randomized trial with two parallel groups of smokers scheduled for surgery comparing surgery alone and surgery with preoperative smoking cessation. The investigators plan to randomize 251 patients. The primary endpoint is the Comprehensive Complication Index up to a 90-day postoperative period. The secondary endpoints include comparison of smoking abstinence, quality of life, mental health, length of stay, costs of care and difference in hospital reimbursement between the two groups.

Discussion: The hypothesis is that preoperative smoking cessation program improves outcomes in smokers undergoing surgery.

Patients will be randomised in a 1:1 ratio to either the intervention or control group using service of the University of Graz (www.randomizer.at). Before randomisation patients will be pre-stratified for age (≤60, \>60 years) and procedure (intermediate versus high-risk procedures). Both factors have been identified in a previous retrospective cohort study at our institution as risk factors for complications. For that reason, minimization, as an efficient way to control for confounding in small to moderately sized trials, will be used. Also, minimization automatically ensures concealment of random allocation since there is no pre-existing randomization list.

Throughout the study patient data is collected in the electronic health record (LUKiS) in an uncoded manner. Allocation will be blinded. At the end of the study the LUKiS reporting team will generate a report, which will include all study data in a de-identified form. The analysis of the report with the pseudonymized data will be performed by the project statistician.

Preoperative Smoking Cessation in Patients Undergoing Surgery

Preoperative Smoking Cessation Program in Patients Undergoing Intermediate to High-risk Surgery: a Randomized, Single-blinded, Controlled Trial

The primary endpoint is the Comprehensive Complication Index (CCI) within 90 days of surgery. The CCI is calculated as the sum of all Clavien-Dindo complications that are weighted for their severity (multiplication of the median preference values from patients and physicians). The final formula yields a continuous scale that ranks the cumulative burden from any combination of complications from 0 to 100 with higher values indicating a higher cumulative burden in a single patient. As a composite complication score, the CCI has the advantage of reflecting the overall burden of the postoperative course that affects the health of patients and their quality of life. In addition, the CCI is a powerful endpoint in trials, as it allows sample size up to nine times lower compared with traditional morbidity endpoints.

Days of hospital stay for planned surgery

Costs of hospital stay for planned surgery

Readmission rates for in-patient hospital stay after surgery

Number of patients who successfully quit smoking

Decrease or increase of daily nicotine consumption

The outcome is measured using the Hospital anxiety and depression scale (HADS) before surgery. The score ranges from 0 to 42 with higher values indicating a higher probability of a mood disorder.

unplanned postoperative intermediate care or intensive care unit admission

Stage of the Transtheoretical Model of behaviour change

The outcome is measured using the 36-Item Short Form Survey (SF-36). The score ranges from 0 to 100 with higher values indicating a more favorable health state.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Metabolic Signature of Healthy Lifestyle and HCC	NCT03356535	Hepatocellular ...		30 Years - 70 Years	International Agency for Research on Cancer
Metabolic Signature of Healthy Lifestyle and HCC	NCT03356535	Hepatocellular ...		30 Years - 70 Years	International Agency for Research on Cancer
Preoperative Smoking Cessation in Patients Undergoing Surgery	NCT05192837	Smoking Cessati... Smoking Reducti... Surgery--Compli... Surgery Cancer Postoperative C... Perioperative C... Smoking Abdominal Cance... Thoracic Cancer Urologic Cancer Gynecologic Can... Head and Neck C...	Intensive preop...	18 Years -	Luzerner Kantonsspital
Metabolic Signature of Healthy Lifestyle and HCC	NCT03356535	Hepatocellular ...		30 Years - 70 Years	International Agency for Research on Cancer

Spots Global Cancer Trial Database for epic

Every month we try and update this database with for epic cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for epic

Every month we try and update this database with for epic 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 epic 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.