Behaviors and Mental Disorders

All Conditions

Alcohol Drinking

Drinking Behavior

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

Alcohol consumption is a risk factor for numerous health conditions and an important cause of death. Identifying metabolites associated with alcohol consumption may provide insights into the metabolic pathways through which alcohol may affect human health. The objective of this study is to investigate associations of alcohol consumption with circulating concentrations of 123 metabolites including amino acids, acylcarnitines, hexoses, biogenic amines, phosphatidylcholines, and sphingomyelins. For this purpose, the investigators use data from the European Prospective Investigation into Cancer and Nutrition (EPIC) study and applied a discovery and replication approach.

This study used data from 2,974 control participants from four case-control studies on colorectal (n=491), hepatobiliary (n=327), kidney (n=635), and prostate cancer (n=1,521) nested in the EPIC cohort, for which targeted metabolomics data had been acquired. Alcohol consumption at recruitment was self-reported through dietary questionnaires. Metabolite concentrations were measured by tandem mass spectrometry using the BIOCRATES AbsoluteIDQTM p180 kit. Data were randomly divided into discovery (2/3) and replication (1/3) sets. Multivariable linear regression models were used to evaluate confounder-adjusted associations of ln-transformed alcohol consumption with Z-standardized ln-transformed residual metabolite concentrations. Metabolites significantly related to alcohol intake in the discovery set (FDR q-value\<0.05) were further tested in the replication set (Bonferroni-corrected p-value\<0.05). Of the 72 metabolites significantly related to alcohol intake in the discovery set, 34 metabolites were also significant in the replication analysis, including three acylcarnitines, the amino acid citrulline, four lysophosphatidylcholines, 13 diacylphosphatidylcholines, seven acyl-alkylphosphatidylcholines, and six sphingomyelins. Associations with acylcarnitines and phosphatidylcholines were generally positive, while mostly inverse associations were observed with citrulline and sphingomyelins.

This study adds novel knowledge regarding circulating metabolites associated with alcohol consumption, and provides leads for further studies into the underlying biological mechanisms. A better understanding of metabolic pathways affected by alcohol consumption may contribute to the development of mechanism-tailored intervention strategies to prevent and treat alcohol-related conditions. Furthermore, it may help to identify biomarkers of alcohol consumption facilitating early preventive strategies in individuals at-risk for developing alcohol-related morbidities.

Alcohol Consumption and Circulating Metabolites

Circulating Metabolites Associated With Alcohol Intake in the European Prospective Investigation Into Cancer and Nutrition Cohort

Blood concentrations of 123 metabolites including amino acids, acylcarnitines, hexoses, biogenic amines, phosphatidylcholines, and sphingomyelins (BIOCRATES AbsoluteIDQTM p180 kit).

Maastricht University

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

Diarrhea

Shock

Signs and Symptoms, Digestive

Antineoplastic Agents

Amino Acids

Irinotecan

Fluorouracil

Glutamine

Glutamine 10 g four times daily starting two days before treatment for six days in total

Placebo

Michael Sawyer, MD

Irinotecan (7-ethyl-10- {4(-1-piperidino)-1-piperidino} carbonyloxy camptothecin) is a semisynthetic camptothecin derivative introduced in the 1980's. Irinotecan is a prodrug metabolized by carboxylesterases to an active metabolite 7-ethyl-10-hydroxy-camptothecin (SN38). SN38 exerts its cytotoxic effect by forming stable complexes with topoisomerase I and DNA. These complexes collide with replication forks and cause breaks in DNA. Studies substantiated irinotecan's activity in 5FU resistant colorectal cancer and led to its approval for treatment of 5FU resistant colorectal cancer in the United States, Canada and Europe.Colorectal cancer studies demonstrated that single agent irinotecan's dose limiting toxicity was diarrhea occurring 5 to 6 days after its administration. High dose loperamide at first occurrence of diarrhea has decreased the incidence of diarrhea but the incidence of grade 3/4 diarrhea remains high at 28 to 40%.

Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea

Cross Cancer Institute

AHS Cancer Control Alberta

Neoplasms

Nervous System Diseases

Rare Diseases

Neuroendocrine Tumors

Medulloblastoma

Neuroblastoma

Meningioma

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neoplasms, Vascular Tissue

Meningeal Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Glioma

Neuroendocrine Tumor

Neuroepithelioma

Pharmaceutical Solutions

Gastrointestinal Agents

Somatostatin

Octreotide

Edotreotide

Radiopharmaceuticals

Antineoplastic Agents, Hormonal

Arginine

Lysine

Patients will receive 3 doses of 90YDOTATOC followed by 90Y-DOTATOC PET scans, with 6 -8 weeks between doses. They will be followed for 6-9 months after the last treatment dose. CT or MRI scans will be given at the 3 month and 6-9 month followups plus a 68Ga-DOTATOC or DOTATATE PET scan at the 6-9 month followup. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry.

90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors.

90Y-DOTA tyr3-Octreotide

68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors.

68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan

This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys.

M. Sue O'Dorisio, MD, PhD

This is a Phase 2 peptide receptor radionuclide therapy trial of 90Y-DOTATOC in patients with somatostatin receptor positive tumors.

This is a Phase 2 peptide receptor radionuclide therapy trial of 90Y-DOTATOC in patients with somatostatin receptor positive tumors. The somatostatin receptor targeting of the therapeutic will be checked with 68Ga-DOTATOC PET-CT imaging prior to therapy. Treatment consists of 3 cycles, 6-8 weeks apart. Cycle 1 dose is fixed with Cycles 2 and 3 doses to be determined by dosimetry-based calculation of renal doses from previous cycles not to exceed 23 Gy for the total renal dose.

The goals of this project are to

1. Demonstrate the safety and efficacy of dosimetry-guided peptide receptor radiotherapy using 90Y-DOTA-tyr3-Octreotide in patients with neuroendocrine and other somatostatin receptor expressing tumors.
2. Monitor all adverse events associated with peptide receptor radiotherapy using 90Y-DOTATOC.
3. Establish 68Ga-DOTA-tyr3-Octreotide (68Ga-DOTATOC) or 68Ga-DOTATATE PET/CT as an accurate technique for diagnosis, staging, treatment targeting, and monitoring response to 90Y-DOTATOC therapy.

Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC)

Phase II, Dosimetry Guided, Peptide Receptor Radiotherapy (PRRT) Using 90Y-DOTA tyr3-Octreotide (90Y-DOTATOC) in Children and Adults With Neuroendocrine and Other Somatostatin Receptor Positive Tumors

Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) was used to quantify tumor response by comparison of baseline and last follow-up visit (6-9 months after last treatment) diagnostic CT/MRI scans.

The percentage of patients who experience a grade 4 or higher renal adverse event. Renal adverse events were graded using CTCAE v4.0 criteria.

The percentage of patients who experience a grade 4 or higher irreversible adverse event. Adverse events were graded using CTCAE v4.0 criteria.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

University of Iowa

Professor

Patients will receive 3 doses of 90YDOTATOC followed by 90Y-DOTATOC PET scans, with 6 -8 weeks between doses. They will be followed for 6-9 months after the last treatment dose. CT or MRI scans will be given at the 3 month and 6-9 month followups plus a 68Ga-DOTATOC or DOTATATE PET scan at the 6-9 month followup. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry.

90Y-DOTA tyr3-Octreotide: 90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors.

68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan: 68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors.

Amino Acids: This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys.

90Y-DOTA-tyr3-Octreotide

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Frequency of Tumor Response at 9 Months After Last Treatment

Percentage of Patients With Grade 4 or Higher Renal Adverse Event.

Patients will receive 3 doses of 90YDOTATOC, with 6 -8 weeks between doses. They will be followed for 6 monthsafter the last treatment dose. CT or MRI scans will be given at the 3 month and 6 month followups. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry.

90Y-DOTA tyr3-Octreotide: 90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors.

Amino Acids: This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys.

Percentage of Patients With Grade 4 or Higher Irreversible Adverse Events

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Alcohol Consumption and Circulating Metabolites	NCT03402568	No Condition, F...		30 Years - 70 Years	International Agency for Research on Cancer
Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea	NCT00255229	Metastatic Colo...	Glutamine Placebo	18 Years -	AHS Cancer Control Alberta
Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea	NCT00255229	Metastatic Colo...	Glutamine Placebo	18 Years -	AHS Cancer Control Alberta
Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC)	NCT03273712	Neuroendocrine ... Meningioma Neuroblastoma Medulloblastoma	90Y-DOTA tyr3-O... 68Ga-DOTATOC PE... Amino Acids	6 Months - 90 Years	University of Iowa
Alcohol Consumption and Circulating Metabolites	NCT03402568	No Condition, F...		30 Years - 70 Years	International Agency for Research on Cancer
Alcohol Consumption and Circulating Metabolites	NCT03402568	No Condition, F...		30 Years - 70 Years	International Agency for Research on Cancer

Spots Global Cancer Trial Database for amino acids

Every month we try and update this database with for amino acids 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 amino acids

Every month we try and update this database with for amino acids 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 amino acids 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.