Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Adenocarcinoma

Adenocarcinoma of Lung

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Adenocarcinoma

Mingming Deng, MD

The goal of this observational study is to learn about local and peripheral immune and metabolic changes in patients with lung adenocarcinoma undergoing cryoablation. The main question it aims to answer are:

* local and peripheral immune changes in patients with lung adenocarcinoma undergoing cryoablation.
* local and peripheral metabolic changes in patients with lung adenocarcinoma undergoing cryoablation.

Peripheral blood, biopsy tissues of patients will be collected at the baseline and after cryoablation. Single-cell sequencing, single-cell immune bank, metabolomics and spatial metabolomics will be used to explore the local and peripheral immune changes and metabolites changes in patients with lung adenocarcinoma before and after cryoablation.

Local and Peripheral Immune Responsive Landscape Induced by Local Cryoablation in Patients With Lung Adenocarcinoma

China-Japan Friendship Hospital

Principle Investigator

Skin and Connective Tissue Diseases

Breast Neoplasms

Collection of a venous blood sample to investigate metabolic changes in blood

Venous blood sample

Michiel Thomeer, prof. dr.

Kurt Baeten, dr.

This study aims to determine whether metabolic changes occur in blood plasma of cancer patients, and whether these changes can be used as a biomarker to detect cancer. These analyses will be done by means of nuclear magnetic resonance (NMR) spectroscopy.

Metabolic Changes as a Diagnostic Indicator for Cancer

Significant metabolic changes in blood between cancer patients \& control subjects

Ziekenhuis Oost-Limburg

Algemeen Ziekenhuis Vesalius

Ziekenhuis Maas en Kempen

Mariaziekenhuis Noord-Limburg

Hasselt University

prof. dr.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Other Dietary Supplements

Sulforaphane

Volunteers will be required to consume one portion of broccoli soup per week as part of their normal diet for one year.

Standard broccoli soup

Volunteers will be required to consume one portion per week of a soup containing glucoraphanin-enriched broccoli (Beneforte®) as part of their normal diet for one year.

Beneforte broccoli soup

Volunteers will be in which they will be required to consume one portion per week of a soup containing an other variety of glucoraphanin-enriched broccoli (Beneforte extra) as part of their normal diet for one year.

Beneforte extra broccoli soup

Richard Mithen, PhD

The biology of prostate cancer is associated with changes in genes and metabolites within prostate tissue. There is robust evidence to suggest that a diet rich in broccoli can prevent or retard the development of prostate cancer by influencing these changes. This is likely to be due to a natural chemical that is obtained in these vegetables known as sulforaphane.

In this study, we are seeking to provide further evidence that a diet rich in broccoli may prevent prostate cancer from developing, and to understand how this may happen. We propose to undertake a human intervention study to test the hypothesis that a broccoli-rich diet can alter the metabolism and gene expression within prostate tissue of men under active surveillance in a manner that would reduce the probability of the emergence and progression of aggressive cancerous clones. Participants recruited onto this study will be randomly allocated to one of three dietary groups in which they will be required to consume one portion per week of a broccoli soup delivering a different concentration of sulforaphane. This will be part of their normal diet for one year.

Blood, urine and prostate biopsy tissue will be obtained before and after a 12 month intervention period. Prostate biopsies will be obtained either though transperineal template biopsies, a technique accepted as best clinical practice because it provides better sampling of the prostate, or transrectal ultrasound guided biopsy which is currently the standard of care for obtaining biopsies.

This study has been funded by Biotechnology and Biological Sciences Research Council (BBSRC) and Prostate Cancer foundation (PCF).

The study is a randomised double-blinded dietary intervention study. The study population will consist of smoking and non-smoking men aged between 18 and 80 years old. Participants recruited into this study will be randomly placed into one of three dietary groups in which they will be required to consume one portion of broccoli soup per week, delivering a different level of glucoraphanin (sulforaphane precursor), as part of their normal diet for one year. The three types of soup will contain (i)standard broccoli, (ii)glucoraphanin-enriched broccoli (Beneforte®), or (iii)Beneforte extra. Beneforte and Beneforte extra broccoli are especially cultivated to deliver high sulforaphane levels after consumption. All the three broccoli varieties have the same appearance and flavour thus enabling a blinded human intervention study to be undertaken. Broccoli soups will be manufactured by a food company that supplies soups to the leading supermarket retailers in the United Kingdom. In order to assess the habitual diet of the participants, they will be asked to keep three 7-day diet diaries, one pre-intervention, after 6-months and another one week before the end of their intervention. Considering the effect of exercise on whole body metabolism we will also obtain information on the physical activity of study participants. They will be asked to complete a validated physical activity questionnaire together with the diet diary (i.e before starting the study diet then at 6 and 12 months). Twenty six participants will be recruited to each of the broccoli groups. The participants will be characterised as having a low or intermediate risk of developing prostate cancer and will be undergoing active surveillance. A number of physiological tests will be performed on the participants before they start the dietary intervention (baseline) and after their 12 months on the intervention. The study will involve collection of prostate biopsies, blood and urine samples at baseline and after a 12 month dietary intervention. Prostate biopsies will be obtained through transperineal template biopsy (TPB) where possible or standard transrectal ultrasound scan guided biopsy (TRUS biopsy). TPB is a clinical procedure carried out under a general or regional anaesthetic which gives more detailed information about the position, amount and aggressiveness of the cancer within the prostate than other standard techniques. However, patients who do not wish to undergo TPB can alternatively choose the standard TRUS biopsy.

At the end of the trial participants will be asked to give written consent if they wish to continue the diet for a further 12 months. Consenting patients will thereafter be required to eat one portion of broccoli soup per week for 12-months. We will not ask participants to attend extra hospital visits for the purpose of the study or give additional biological samples; instead we will capture clinical data related to their follow up of prostate cancer.

It is anticipated that the dropout rate for this study will be approximately 25% due to the clinical progression of prostate cancer within the 12-month study period. In the event of clinical progression the volunteer will discontinue the intervention, receive advice from the urologist in charge and in case of prostatectomy will be asked to donate part of their prostate gland for research purposes.

Effect of Sulforaphane on Prostate CAncer PrEvention

A Human Dietary Intervention Study to Investigate the Effect of Sulforaphane on Prostate Cancer Interception

To determine whether a 12 month diet rich in broccoli will result in changes in global gene expression in prostate tissue from men diagnosed with low- and intermediate- risk prostate cancer on active surveillance.

To determine whether a 12 month diet rich in broccoli will results in changes in levels of metabolites in prostate tissue from men diagnosed with low- and intermediate- risk prostate cancer on active surveillance.

Prostate Cancer Foundation

Biotechnology and Biological Sciences Research Council

Quadram Institute Bioscience

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Wounds and Injuries

Diabetes Mellitus

Syndrome

Fractures, Bone

Metabolic Syndrome

Androgens

This is an observational, prospective, non-interventional and multi-centre study, to assess the impact of androgen ablation therapy in blood triglycerides, cholesterol and glucose, body fat distribution and fracture risk to ten years using FRAX model in patients with prostate cancer. The patients will be following for 12 months

Metabolic Changes in Prostate Cancer Patients With Androgen-ablation Therapy (AAT)

AstraZeneca

Nervous System Diseases

Muscular Atrophy

Wasting Syndrome

Cachexia

Lung Diseases

Respiratory Tract Diseases

Weight Loss

Body Weight

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

Fluorodeoxyglucose F18

This arm includes 150 treatment-naive lung cancer patients. Assessments include medical history, physical exams, lab tests, and imaging. Objective: investigate cancer cachexia, stress, and metabolic changes. Cachexia criteria: weight loss, reduced food intake, inflammation markers. Stress assessment: questionnaires, biomarkers. Metabolic changes measured by PET-CT scans analyzing FDG uptake in organs/lesions. Data will uncover the relationship between cancer cachexia, stress, and metabolic changes in treatment-naive lung cancer patients, leading to improved interventions/outcomes.

A subgroup of patients from Vienna will undergo an additional PET/CT scan after the first follow-up PET/CT, which takes place one month after stress reduction training. The stress reduction training involves performing a breathing technique.

Stress Reduction Training

Marcus Hacker, Prof., MD

Josef Yu, MD

Andreas Bergthaler, Prof.

Osama Sabri, Prof.

Roberto Sciagra, Prof.

Marcus Hacker, Prof.

Thomas Beyer, Prof.

Roberto Sciagrà, Prof.

This prospective observational study aims to investigate the relationship between cancer cachexia, stress levels, and metabolic changes in 150 lung cancer patients. Cancer cachexia, characterized by weight loss and muscle wasting, significantly impacts patient outcomes. Psychological stress is thought to contribute to cachexia development. Assessments will include medical history, physical examinations, laboratory tests, and imaging. Cancer cachexia will be diagnosed based on weight loss, reduced food intake, and inflammation markers. Psychological stress will be evaluated using questionnaires and biomarkers. Metabolic changes will be assessed using positron emission tomography-computed tomography (PET-CT) scans. The primary objective is to determine differences in metabolic activity between cachectic and non-cachectic patients. Secondary objectives include evaluating changes in brain activity and exploring the relationship between stress, inflammation, and metabolism.

Title: Investigation of the Relationship Between Cancer Cachexia, Stress, and Metabolic Changes in Lung Cancer Patients

Background: Cancer cachexia is a debilitating syndrome characterized by progressive weight loss, muscle wasting, and metabolic abnormalities. It significantly impacts patients' quality of life and survival outcomes. Psychological stress has been suggested as a potential contributor to cachexia development and progression. This study aims to investigate the association between cancer cachexia, stress levels, and metabolic changes in lung cancer patients.

Methods: This multicenter, prospective observational study will enroll 150 lung cancer patients. Eligible participants will undergo comprehensive assessments, including medical history review, physical examinations, laboratory tests, and diagnostic imaging. Cancer cachexia will be diagnosed based on established criteria, including weight loss, reduced food intake, and systemic inflammation markers. Psychological stress will be evaluated using validated questionnaires and stress biomarkers. Metabolic changes will be assessed through positron emission tomography-computed tomography (PET-CT) scans to measure fluorodeoxyglucose (FDG) uptake in organs and lesions.

Primary Objectives: The primary objective is to determine differences in FDG uptake between cachectic and non-cachectic lung cancer patients in various organs and lesions. Secondary objectives include evaluating changes in amygdalar FDG uptake after stress intervention and exploring the relationship between stress, inflammatory markers, and metabolic changes.

Statistical Analysis: Student's t-test will be used to compare FDG uptake between groups, and descriptive statistics will be calculated for each brain region. Sample size calculations indicate a need for approximately 30 subjects per group to detect significant differences. Data will be analyzed using appropriate statistical software.

Ethical Considerations: Informed consent will be obtained from all participants, and the study will adhere to the principles outlined in the Declaration of Helsinki and Good Clinical Practice guidelines. The study protocol has been submitted to the Ethics Committee and regulatory authorities for approval.

Conclusion: This study aims to provide insights into the relationship between cancer cachexia, stress, and metabolic changes in lung cancer patients. By investigating FDG uptake in different organs and lesions, as well as amygdalar FDG uptake before and after stress intervention, this research may contribute to the development of targeted interventions for cachexia management and improve patient outcomes.

The overall model of this study involves enrolling a total of 150 patients from three different sites. These patients will undergo baseline PET/CT imaging to assess their metabolic changes, as well as provide clinical information through medical history review and physical examinations. Additionally, blood samples will be collected for laboratory tests, and patients will complete questionnaires to evaluate psychological stress levels. This comprehensive approach aims to gather a range of data including imaging, clinical information, blood biomarkers, and psychological assessments to investigate the relationship between cancer cachexia, stress, and metabolic changes in lung cancer patients.

Predicting Lung Cancer-Associated Cachexia With PET Imaging

The Role of 18F-FDG PET/CT in the Early Prediction of Cachexia in Lung Cancer Patients

Measurement of fluorodeoxyglucose (FDG) uptake in various organs and lesions to characterize the metabolic differences between cachectic and non-cachectic lung cancer patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Local and Peripheral Immune Responsive Landscape Induced by Local Cryoablation in Patients With Lung Adenocarcinoma	NCT06104709	Lung Adenocarci... Local Cryoablat...		18 Years - 90 Years	China-Japan Friendship Hospital
Metabolic Changes as a Diagnostic Indicator for Cancer	NCT02362776	Breast Cancer Lung Cancer	Venous blood sa...	-	Hasselt University
Effect of Sulforaphane on Prostate CAncer PrEvention	NCT01950143	Prostate Cancer	Standard brocco... Beneforte brocc... Beneforte extra...	18 Years - 80 Years	Quadram Institute Bioscience
Metabolic Changes in Prostate Cancer Patients With Androgen-ablation Therapy (AAT)	NCT01284608	Prostatic Cance...		18 Years -	AstraZeneca
Predicting Lung Cancer-Associated Cachexia With PET Imaging	NCT05912465	Cachexia Lung Neoplasm	Stress Reductio...	18 Years -	Medical University of Vienna
Effect of Sulforaphane on Prostate CAncer PrEvention	NCT01950143	Prostate Cancer	Standard brocco... Beneforte brocc... Beneforte extra...	18 Years - 80 Years	Quadram Institute Bioscience

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