Butadiene is a suspect human carcinogen to which most people are exposed daily. Exposures are difficult to measure by air sampling. This study examines the relationship between air levels and several biomarkers of exposure. Biomarkers are substances analyzed in human tissues or waste products. Adducts are materials formed when a chemical reacts with a biological material. In this study we are looking at biomarkers in the blood: hemoglobin and DNA adducts, and urinary metabolites. If a strong relationship is found then the amounts of biomarkers in a person's blood or urine can tell us how much they have been exposed. The tests are being conducted on petrochemical workers who have a wide range of exposures to butadiene. An international group of investigators is conducting the study.

Collaborative Study of 1,3 Butadiene Biomarkers

National Institute of Environmental Health Sciences (NIEHS)

Neoplasms

Nervous System Diseases

All Conditions

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Katherine E Warren, M.D.

Brain tumors represent the most common solid tumor of childhood. Treatment generally entails surgery and radiation, but local recurrence is frequent. Chemotherapy is often used in an adjuvant setting, to delay radiation therapy or for resistant disease. Children with brain tumors are generally followed by imaging studies, such as CT or MRI. Difficulty arises in trying to distinguish tumor regrowth from treatment related edema, necrosis or radiation injury. Proton Nuclear Magnetic Resonance Spectroscopic (NMRS) Imaging is a non-invasive method of detecting and measuring cellular metabolites in vivo. NMRS imaging complements routine MRI by giving chemical information in conjunction with spatial information obtained by MRI.

This study will be conducted to determine NMRS imaging patterns before, during and after chemotherapy in pediatric patients with primary or metastatic brain tumors in an attempt to identify and characterize specific patterns of metabolites related to tumor regrowth, tumor response to therapy, edema or necrosis.

Background:

* Brain tumors represent the most common solid tumor of childhood. Treatment generally includes surgery and radiation, but recurrences are frequent, particularly for high-grade lesions.
* Chemotherapy is often used in an adjuvant setting, to delay radiation therapy or for resistant disease.
* Children with brain tumors are generally followed by imaging studies, such as CT or MRI.
* Difficulty arises in trying to distinguish tumor regrowth from treatment related edema, necrosis or radiation injury.
* Proton Nuclear Magnetic Resonance Spectroscopic (NMRS) Imaging is a non-invasive method of detecting and measuring cellular metabolites in vivo.

Objective:

* To determine NMRS imaging patterns before, during and after chemotherapy in pediatric patients with primary or metastatic brain tumors
* To identify and characterize specific patterns of metabolites related to tumor regrowth, tumor response to therapy, edema or necrosis.

Eligibility:

* Age less than or equal to 21 years.
* Patients entered on this trial will also be entered on one of the Branch s primary brain tumor treatment trials.
* Histologically confirmed primary or metastatic brain tumor. Patients with a brainstem glioma or optic pathway gliomas are not required to have a histologic diagnosis.
* Measurable or evaluable tumor at the time of study entry.

Design:

* This is intended to be a pilot study to define metabolite patterns associated with tumor growth, tumor edema and tumor necrosis as seen on standard MRI; and determine the feasibility of using metabolite patterns to predict response to therapy in pediatric patients with brain tumors.
* Contalateral spectroscopic analysis of normal appearing brain will also be performed when feasible.
* Analysis of results will be stratified according to type of tumor, and prior history of radiation therapy or surgery.

A Pilot Study of 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Pediatric Patients With Primary and Metastatic Brain Tumors

in vivo measurements of tissue metabolites (NAA, Cho,Cr, Lac) and what they reflect

measurements and differences of signal intensity of peaks obtained for tissue metabolites (NAA, Cho, Cr, Lac)

Contalateral spectroscopic analysis results, stratified according to type of tumor, history of radiation therapy or surgery

National Cancer Institute (NCI)

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Chronic Graft Versus Host Disease

Hematinics

All Drugs and Chemicals

Liver Extracts

Pierce Chow, MD, PhD

Guan Huei LEE, MD, PhD

Sabrina WEE, MD

Pierce CHOW, MD, PhD

Han Chong TOH, MD

Kok Kiong ONG, MD

Jason Pik Eu CHANG, MD

Wei Lyn YANG, MD

Kee Tung TAN, MD

Oi Fong CHONG, MD

Ngiap Chuan TAN, MD

SULAIHA Binte Ithnin, MD

Eugene Yu Jun WONG, MD

Marianne Anastasia DE ROZA, MD

Jeremy Wei Song CHOO, MD

Xin Yi YEAP, MD

Hepatocellular carcinoma (HCC) is the 7th most common cause of cancer death globally but only 20% are diagnosed in its early stages where cure is possible. Current standard-of-care surveillance of patients at high risk of developing HCC with 6-monthly serum alpha-fetoprotein (AFP) and ultrasound imaging (US) has a sensitivity of approximately 63% for detecting early HCC. There is an urgent need for a more efficacious and convenient modality of surveillance of high-risk patients to diagnose HCC at an early stage.

This prospective study aims to address this unmet clinical need by validating a panel of circulating miRNA biomarkers to develop an in-vitro diagnostic (IVD) kit for the detection of early HCC in a cohort of high-risk patients.

Additionally, this study also aims to develop a multi-parametric MRI-based AI algorithm to quantify individual risks of developing HCC and to predict the progression of chronic liver disease in this cohort to enable targeted surveillance. Lastly, by identifying changes in the microbiome and metabolites as HCC develops in this cohort enables the establishment of actionable biomarkers that can prevent and predict the development of HCC.

Eligible patients will receive 6-monthly standard-of-care surveillance (US, serum AFP and liver function test) for HCC until end of study or up to a maximum of 7 assessments (1 baseline and 6 follow-up assessments). There will be an option for patients to continue to receive standard-of-care surveillance for HCC until end of study or up to 2 additional assessments (Visits 8-9), whichever occurs first.

Patients with elevated AFP or abnormalities detected on US will be investigated with multi-phasic CT scan or MRI to confirm or refute the diagnosis of HCC. Additionally, patients shall be scheduled for sequential bio-samples collection (blood, urine and stool) and blood tests (Hba1c and Lipid Panel) during the course of the study.

Bloods shall be used for relevant laboratory assessments. Blood, urine and stool samples shall be used for miRNA, microbiome and metabolome profiling.

Early Detection of Hepatocellular Carcinoma in a High-risk Prospective Cohort (ELEGANCE)

Early Detection of Hepatocellular Carcinoma (HCC): miRNA, Microbiome and Imaging Biomarkers in the Evolution of Chronic Liver Disease in a High-risk Prospective Cohort (ELEGANCE)

Changes in the profile of circulating micro-RNA biomarkers as high-risk patients develop HCC

value of cT1, PDFF and T2\* levels to predict individual's risk of developing and progression of HCC.

Changes in the profile of gut microbiota as high-risk patients develop HCC.

Changes in the profile of metabolome in urine and plasma as high-risk patients develop HCC.

Duke-NUS Graduate Medical School

Singapore Phenome Centre

Nanyang Technological University

MiRXES Pte Ltd

Perspectum Asia Pte Ltd

Asian Microbiome Library Pte Ltd

National Cancer Centre, Singapore

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Gaber Plavc, MD

Preclinical studies have shown that the response of solid tumors and normal tissues to radiotherapy can be regulated by gut microbiota and its metabolites. In this study, the composition of gut microbiota in patients with locally advanced head and neck cancers undergoing definitive radiotherapy will be analysed together with bacterial metabolites in stool and blood and a possible correlation with treatment outcome and treatment toxicity will be determined.

Head and neck cancer patients commonly present with unresectable locoregionally advanced disease in which radiotherapy is the mainstay of curative-intent treatment albeit at the cost of substantial acute and late toxicity. Recently discovered mechanisms by which gut microbiota and its metabolites impact tumor's and normal tissue's response to radiotherapy offer new ways to improve the therapeutic index of radiotherapy in solid tumors.

COMRAD-HNSCC is a prospective study assessing the correlation between gut microbiota composition and its metabolites and the response to radiotherapy in patients with unresectable locoregionally advanced head and neck cancer. Stool and serum samples will be collected at the beginning and at the end of curative radiotherapy treatment. The composition of gut microbiota will be analysed by ribosomal DNA high-throughput amplicon sequencing of the DNA isolated from stool samples, whereas targeted metabolomics using liquid chromatography-mass spectrometry will be performed on stool and serum samples.

The long-term goal of this study is to deepen the understanding of the role of gut microbiome and its metabolites in efficacy and toxicity of radiotherapy in head and neck cancer, and provide a basis for subsequent exploration to increase therapeutic index by regulating gut microbiota.

Correlation of Fecal Microbiome and Its Metabolites With Outcome of Radiotherapy in Head and Neck Carcinoma

Correlation of Fecal Microbiome and Its Metabolites With Outcome of Radiotherapy in Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (COMRAD-HNSCC)

Objective response rate to radiotherapy according to RECIST 1.1 criteria as measured with computed tomography.

Associations with differences in fecal microbiota composition and in bacterial metabolites will be made between responders and non-responders.

Acute radiation induced mucositis and dermatitis according to CTCAE v3.0 as measured with clinical examination.

Associations with differences in fecal microbiota composition and in bacterial metabolites will be made between patients with a maximum Grade ≤ 2 versus those with a maximum Grade \> 3 acute radiation induced mucositis and dermatitis.

Institute of Oncology Ljubljana

Principal Investigator

Symptoms and General Pathology

Recurrence

Glenn Kunnath BONNEY, MD

Brian GOH, MD

Vishalkumar Girishchandra SHELAT, MD

Adrian CHIOW, MD

Juinn Huar KAM, MD

Hepatocellular carcinoma (HCC) is the 4th most common cause of cancer death globally but only 20% are diagnosed in its early stages where curative treatment can be carried out. Current standard-of-care surveillance of patients at high risk of developing HCC with 6-monthly serum alpha-fetoprotein (AFP) and ultrasound imaging (US) has a sensitivity of approximately 63% for detecting early HCC. There is an urgent need for a more efficacious and convenient modality of surveillance of high-risk patients to diagnose HCC at an early stage. In another study (AHCC10 ELEGANCE, NCT04965259), 2,000 patients at risk of developing HCC will be enrolled to develop the 1st miRNA in-vitro diagnostic (IVD) kit for HCC that has higher accuracy and better ease of use compared with the extant combination of AFP and US.

This prospective study will act as a positive control to the AHCC10 ELEGANCE Study and aims to address the absence of efficacious modalities of surveillance by validating a panel of circulating miRNA biomarkers signatures with histologically proven HCC. This study will determine progressive changes in the profiles of miRNA signatures pre- and post- surgical resection to identify signatures predictive of recurrence.

Additionally, this study also aims to identify changes in key metabolites and microbiome with correlation to changes in choline, bile acid and tryptophan metabolic pathways with changes in the composition and function of gut microbiota to establish actionable biomarkers that can predict HCC recurrence.

This is a prospective study involving 100 patients with diagnosis of hepatocellular carcinoma (HCC) confirmed by histology at surgical resection. Eligible patients will receive CT scans at 6 months and 12 months post-surgery to monitor for recurrence. Pre- and post-surgery bio-samples (blood, urine, stool) will also be collected to monitor changes in profiles of miRNA, metabolome and microbiome.

Blood samples shall be used for relevant laboratory assessments. Blood, urine and stool samples shall be used for miRNA, microbiome and metabolome profiling.

Prospective Cohort Study of Changes in Circulatory MicroRNA of Resected Hepatocellular Carcinoma

Prospective Cohort Study of Changes in Circulatory MicroRNA After Surgical Resection of Hepatocellular Carcinoma (HCC) (PROSECT)

Changes in the profile of circulating micro-RNA biomarkers pre- and post- surgical resection.

Differences in the profile of gut microbiota among HCC and healthy population retrieved from database.

Changes in the profile of metabolome in urine and plasma pre- and post- surgical resection.

Asian Microbiome Library (AMiLi) Pte Ltd

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

240 grams (raw weight) of red and processed meat every day for 2 weeks

240 grams (uncooked weight) of Quorn every day for 2 weeks

Integration of 240 grams (raw weight) of red and processed meat into daily diet for 2 week period.

Red and Processed Meat

Integration of 240 grams (uncooked weight) of Quorn into daily diet for 2 week period.

Quorn

daniel M commane, PhD

This study will evaluate the effects of substituting red and processed meat in the diet with Quorn; a meat replacement product, on biomarkers of gut health. This will be a crossover design where participants will take part in 2 study periods where they will consume a diet containing red and processed meat during one of the study periods, whereas in the other study period, they will consume a diet containing Quorn.

There is a strong association between a diet which is high in red and processed meat, while low in fibre, and the incidence of colorectal cancer. This study aims to evaluate the effects of replacing red and processed meat in the diet with an alternative meat product such as Quorn, on biomarkers of gut health that may be associated with colorectal cancer.

Quorn is a product which has a considerable fibre component; thus, the replacement of red and processed meat with Quorn, will not only reduce the amount of compounds implicated to have deleterious effects in the gastrointestinal tract (E.G. haem, nitroso compounds, heterocyclic amines), but will also increase the delivery of fibre into the gastrointestinal system, that may well have an overall positive impact on gut health.

In this study, the participants will consume 240 grams (raw weight) of either red and processed meat, or Quorn each day for a 2 week period, this will be followed by a 4 week period where they will return to their usual dietary habits; before swapping to consume the alternative food (red/processed meat or Quorn) for another 2 week period.

The Effects of Replacing Red and Processed Meat With Quorn on Biomarkers of Gut Health

The Effects of Replacing Red and Processed Meat With Quorn on Markers of Gastrointestinal Health

De-identified individual participant data for all primary and secondary outcome measures will be made available.

Changes in levels of cholesterol in blood samples

Changes in levels of glucose in blood samples (HbA1c)

Changes in the DNA damage causing capacity of aqueous stool extracts, assessed against HT29 and Caco-2 cells using the Comet assay.

Changes in the concentration of 8-Hydroxyguanosine levels in urine samples.

Changes from baseline in the concentration of short chain fatty acids in stool samples, measures of propionate, acetate, butyrate valerate and isovalerate via Gas Chromatography.

Evaluation of post-intervention changes in the composition of the stool microbiota composition from baseline samples.

Change in the concentration of the genotoxic metabolite para-cresol in urine samples

Evaluation of change in the abundance of microRNAs in plasma separated from blood samples following the intervention.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Collaborative Study of 1,3 Butadiene Biomarkers	NCT00023140	Cancer		19 Years - 65 Years	National Institute of Environmental Health Sciences (NIEHS)
Collaborative Study of 1,3 Butadiene Biomarkers	NCT00023140	Cancer		19 Years - 65 Years	National Institute of Environmental Health Sciences (NIEHS)
A Pilot Study of 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Pediatric Patients With Primary and Metastatic Brain Tumors	NCT00001574	Brain Neoplasm Brain Cancer Brain Tumor, Pr...		- 21 Years	National Institutes of Health Clinical Center (CC)
Early Detection of Hepatocellular Carcinoma in a High-risk Prospective Cohort (ELEGANCE)	NCT04965259	Liver Diseases		40 Years - 90 Years	National Cancer Centre, Singapore
Correlation of Fecal Microbiome and Its Metabolites With Outcome of Radiotherapy in Head and Neck Carcinoma	NCT05156177	Head and Neck S...		18 Years -	Institute of Oncology Ljubljana
Prospective Cohort Study of Changes in Circulatory MicroRNA of Resected Hepatocellular Carcinoma	NCT05148572	Hepatocellular ...		21 Years - 90 Years	National Cancer Centre, Singapore
The Effects of Replacing Red and Processed Meat With Quorn on Biomarkers of Gut Health	NCT03944421	Colorectal Canc...	Red and Process... Quorn	18 Years - 50 Years	Northumbria University
Collaborative Study of 1,3 Butadiene Biomarkers	NCT00023140	Cancer		19 Years - 65 Years	National Institute of Environmental Health Sciences (NIEHS)
Early Detection of Hepatocellular Carcinoma in a High-risk Prospective Cohort (ELEGANCE)	NCT04965259	Liver Diseases		40 Years - 90 Years	National Cancer Centre, Singapore

Spots Global Cancer Trial Database for metabolites

Every month we try and update this database with for metabolites 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 metabolites

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