Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Nervous System Diseases

Substance Related Disorders

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Neurotoxicity Syndromes

Neoplasms by Histologic Type

Hematologic Diseases

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Antineoplastic Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Methotrexate

Folic Acid

Vitamin B Complex

Folinic Acid

Folate

Vitamin B9

Leukemia survivors with neuro-cognitive deficit phenotype. Based on DIVERGET and other phenotyping tools, we will identify those with the deficit phenotype. This will be treated as "case".

Leukemia survivors who did not show impaired neurocognitive function, compared to the Control group defined above.

Dr. Shinya Ito, MD

Dr. Sharon Guger

Dr. Johann Hitzler

Dr. Deborah L O'Connor

Dr. Russell Schachar

Dr. Brenda Spiegler

Dr. Rosanna Weksberg

To find possible therapeutic targets to help prevent long-term brain and behavioural side effects in survivors of childhood leukemia that may have been caused by chemotherapy (Treatment-Related late Adverse Neuro-Cognitive Effects: TRANCE). The study hypothesis is that genetic variations of the elements in the folate-related cycles and methotrexate disposition networks are associated with the deficit phenotype (TRANCE) of childhood leukemia survivors.

Hypothesis Genetic variants of the elements in the folate-related cycles and methotrexate disposition networks are associated with the TRANCE phenotype of childhood leukemia survivors.

Objectives

1. To identify TRANCE phenotypes of the childhood leukemia survivors.
2. To characterize the folate and vitamin B12 levels of these children
3. To identify DNA methylation patterns associated with TRANCE trait in the leukemia survivors
4. To identify SNPs associated with the TRANCE trait in the leukemia survivors.
5. To identify the "deficit genotype" associated only with the TRANCE leukemia survivors, but not with general population children who show developmental phenotypes similar to TRANCE: TRANCE-unique deficit variant
6. To replicate the association between the TRANCE-unique deficit variants and the TRANCE trait in a population of childhood leukemia survivors.
7. To evaluate the importance of rare genetic variants in the TRANCE trait in the leukemia survivors.

Study design: A case-control study of leukemia survivors

Analyses

1. Leukemia survivors will be characterized by their status of neurocognitive function, and categorized into the Deficit case and the non-deficit Control case.
2. They will be also characterized by the following attributes

   1. Pathway-based genetic variant status (folate and PK-related genes)
   2. Folate and vitamin B12 status
   3. Epigenetic markers
3. Comparative analyses between neuro-cognitiive deficit phenotype (TRANCE) and Control on those parameters

DNA samples obtained via blood, saliva and buccal sample collection.

N-PhenoGENICS: Neurocognitive-Phenome, Genome, Epigenome and Nutriome In Childhood Leukemia Survivors

DNA methylation signals represent one of the most stable epigenetic markers, which are known to be affected by environmental factors including drugs and nutrients such as folate. Environmental information conveyed through these factors is translated into gene expression changes mediated by DNA methylation. Although this may contribute to neuro-cognitive deficits of the leukemia survivors, there is no prior data in this regard. Therefore, the aim of this exploratory analysis is to determine if there is any indication that DNA methylation patterns are altered in the participants. DNA will be isolated from each of the blood, buccal swab, and saliva samples and modified using sodium bisulfite, which will then be used to determine DNA methylation patterns.

This is a short battery of tests that has been shown to be predictive of both global and academic impairment in survivors of childhood cancer. All neuro-cognitive tests are done on a same day.

Response inhibition, disturbed by behavioral inattention, will be characterized using our task-based computer program, the Stop Signal Task (SST). All neuro-cognitive tests are done on a same day.

To characterize behavioural aspects, we will administer the standard measure based on parent report. All neuro-cognitive tests are done on a same day.

In the hypothesis-driven genome-wide approach, we will focus on the candidate pathways/regions including (but not limited to): a) Folate/methionine cycle genes and transporters; b) drug metabolizing enzymes and transporters (including families of CYP, SLC and ABC transporters); c) epigenetic modifying factors; and d) neuro-regeneration and tissue repair.

In order to confirm validity of DIVERGT in our sample, and provide the data source for future studies, we will include tests of general cognitive function (WISC-IV). All neuro-cognitive tests are done on a same day.

In order to confirm validity of DIVERGT in our sample, and provide the data source for future studies, we will include tests of general cognitive function: WIAT-III numerical operations and math fluency composite score. All neuro-cognitive tests are done on a same day.

In order to confirm validity of DIVERGT in our sample, and provide the data source for future studies, we will administer Brief Rating Inventory of Executive Function (BRIEF), which is designed to assess executive functioning in the home environment. All neuro-cognitive tests are done on a same day.

In order to confirm validity of DIVERGT in our sample, and provide the data source for future studies, we will administer N-Back Task, which is a continuous performance computerized task used to measure aspects of working memory. All neuro-cognitive tests are done on a same day.

Folate and other vitamin intakes vary among individuals. Folic acid fortification in Canadian food product has changed the Canadian population norm of folate status, virtually eliminating folate deficiency status. However, a large inter-individual variation still remains. We will use a Supplement Questionnaire to capture information on all and any supplements that participants may be currently taking.

In order to complement the Supplement Questionnaire (above), we will measure the folate concentration in plasma and red blood cells.

Vitamin B12 and folate pathways interact to maintain biochemical homeostasis. To complement the intake assessment (above), we will measure serum vitamin B12.

Iron status affects cognitive function of children. In addition to the intake assessment (above), we will estimate iron status by measuring hemoglobin and soluble transferrin receptor.

Canadian Institutes of Health Research (CIHR)

Canadian Cancer Society (CCS)

C17 Council

Garron Family Cancer Centre

Pediatric Oncology Group of Ontario

The Hospital for Sick Children

Division Head, Clinical Pharmacology and Toxicology

Infections

Papilloma

Virus Diseases

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Vitamin B 12

Hydroxocobalamin

Trace Elements

Methylcobalamin

Vitamin B12

Cobalamin

Cyanocobalamin

women who did not have intraepithelial neoplasia as a result of smear

women who have atypical squamous cells of undetermined significance (ASCUS) as a result of smear

Vitamin B12 and folate

Non-classified atypical squamous cells (ASCUS) is the most common abnormal cervical cytology (%39). The risk of cervical intraepithelial neoplasia 2-3 is 5% and the risk of carcinoma is around 0.1% after diagnosis. Mostly human papillomavirus (HPV) is responsible for this transition. Most of them are transient, but some infections become persistent and can progress into precancer and invasive cancer. In the process of progression to cancer; patients with cell cycle problems are thought to be at risk. In some studies, B12 and folate deficiency, which play a role in DNA synthesis and repair, have been shown to induce incorrect binding of uracil to DNA, leading to DNA breakage and repair disorder. Therefore, in this study, it has been aimed that the relation of presence of atypical squamous cells and HPV persistence with folate and vitamin B12 levels which effect on immune system.

Participants were divided into two groups according to their smear results; atypical squamous cells of undetermined significance (ASCUS) (study group: 100 patients) and women who did not have intraepithelial neoplasia as a result of smear (control group: 100 patients). Patients who had well preserved sufficient number of squamous epithelial cells, who did not have bleeding, fixation failure, inflammation or atrophy, and had negative cervical cytology smear were considered as control group. HPV test was also requested from the study group. B12 and folate blood levels were compared between the groups.

Can B12 and Folate Levels Predict HPV Penetration in Patients With ASCUS?

Serum Levels of Folate And Vitamine B12 in Patients Infected With HPV and Diagnosed Atypical Squamous Cells of Undetermined Significance in Cervical Cytology

the vitamine B12 levels in patients with ASCUS (+) smear.

the folate levels in patients with ASCUS (+) smear.

Sisli Hamidiye Etfal Training and Research Hospital

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Ph.D. Assistant Professor Department of Obstetrics and Gynecology

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Carcinoma

Carcinoma, Squamous Cell

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neoplastic Processes

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Amino Acids

Dexamethasone

Bevacizumab

Pemetrexed

Dexamethasone acetate

BB 1101

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Folic Acid Antagonists

Glutamic Acid

pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV). In addition to Vitamin B12 + Folate + Dexamethasone

15 mg/kg, IV over 10 minutes every 3 weeks

500 mg/m²; IV over 10 minutes every 3 weeks

1000 micrograms, IM injection 1-2 weeks prior to treatment and repeated every 9 weeks until last dose of pemetrexed

350 to 1000 micrograms 1 week prior to treatment and 3 weeks after last pemetrexed dose

4 mg; oral, twice a day at the following times: the day before, of and after each dose of pemetrexed

Heather A. Wakelee

This trial evaluated the safety of combining bevacizumab and pemetrexed in non-small cell lung cancer (NSCLC) patients with stable brain metastases as second-line chemotherapy, while evaluating progression-free survival (PFS) and overall survival (OS).

Brain metastases are a common complication of advanced non-small-cell lung cancer (NSCLC) both at initial presentation and at the time of disease progression. Patients with brain metastases have often been excluded from large randomized phase III trials due to concerns of poorer survival and impaired ability of drugs to cross the blood-brain barrier. However, as survival has improved, some trials have included such patients, often finding similar benefit to patients with metastatic disease elsewhere.

Bevacizumab is a recombinant, humanized monoclonal antibody against vascular endothelial growth factor, has emerged as an important adjunct to platinum-based chemotherapy doublets for use in advanced NSCLC. This drug is normally used as a first line chemotherapy. Pemetrexed is a multi-targeted anti-folate agent,which is approved for use in first-line (with platinum), maintenance, and second-line treatment of advanced nonsquamous NSCLC. Based on the efficacy of pemetrexed as a second line agent and the safety questions surrounding bevacizumab in those with treated brain metastases, a trial was designed to look at the combination of both agents as a second line therapy in NSCLC patients with treated stable brain metastases

Phase 2 Trial of Bevacizumab in Combination With Pemetrexed

Phase II Trial of Bevacizumab in Combination With Pemetrexed as Second Line Therapy in Patients With Stable Brain Metastases From Non-small Cell Lung Cancer (NSCLC) (Excluding Squamous Cell Carcinoma)

Number of events of brain or central nervous system (CNS) bleeding

Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of documented disease progression or death.

Kaplan-Meier survival curves for PFS were generated with IBM SPSS Statistics version 19.0 (SPSS, Inc, Chicago, IL).

Overall Survival (OS) is defined as the duration of time from start of treatment to deat.

Kaplan-Meier survival curves for OS were generated with IBM SPSS Statistics version 19.0 (SPSS, Inc, Chicago, IL).

Eli Lilly and Company

Genentech, Inc.

Heather Wakelee

Assistant Professor of Medicine

Treatment group is adult patients with metastatic non squamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.

Bevacizumab Plus Pemetrexed

Treatment group is adult patients with metastatic nonsquamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.

Age, Continuous

Gender

Race (NIH/OMB)

ECOG performance status

* 0 = Fully active, able to carry on all pre-disease performance without restriction
* 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg, light house work, office work
* 2 = Unable to work, must sit or lie \> 50% waking hours
* 3 = Capable of limited selfcare; confined to bed or chair \> 50% waking hours
* 4 = Completely disabled; cannot carry on any selfcare; totally confined to bed/chair
* 5 = Deceased

Eastern Cooperative Oncology Group (ECOG) performance status

Adeno-carcinoma

Large cell carinoma

Not otherwise specified (NOS)

Histology refers to the type of non-small cell lung cancer (NSCLC)

Histology

Adult patients with advanced stage nonsquamous NSCLC and stable treated metastatic disease in the brain were eligible if they were candidates for second-line therapy after progression on a platinum doublet regimen for advanced disease.

Heather Wakelee, MD

Bevacizumab + Pemetrexed

All participants in this study are included in the analysis population

Incidence of Central Nervous System (CNS) Hemorrhagic Events

Progression-free Survival (PFS)

Overall Survival (OS)

Overall Study

Nootropic Agents

Lipid Regulating Agents

Choline

Supply nutrition counseling and multivitamin supplement to people with poor nutritional status

Pregnancy diet (include one-carbon nutrients)

nutrition counseling

multivitamin supplement

Chien-Nan Lee

Kuang-Ta Huang

Chin-Pao Cheng

Rwei-Fen S. Huang

Parental one-carbon nutrient intake (folic acid and choline) and the genetic polymorphisms of one-carbon metabolic enzyme were interact with regulating embryonic one-carbon metabolic environment, affect fetal DNA and RNA biosynthesis and methyl modification of the genome molecule, to promote the individual nutrient growth factor of growth and development. Inadequate maternal one-carbon nutrient intake combined with genetic polymorphisms of one-carbon enzymatic mutation, causing one-carbon malnutrition, change fetal methyl metabolic nutrition environment. It not only leads to fetal growth mutation - such as folate and choline deficiency, increasing the risk of fetal neural tube defect but also induce abnormal modifying of fetuses's post-genomic methylation markers, may alter imprinted genes function of progenitors, recompile threshold sensitivity or domain in regulation of metabolic reactions of offspring, resulting in long-lasting effect, increasing the risk of chronic diseases of offspring such as cancer. According to the National Nutrition Survey results show that a considerable proportion of the Taiwanese people had poor one-carbon nutritional status. 48% of women intake 66% below the recommended intake reference value of folate. Whether inadequate parental one-carbon nutrients intake combined with genetic polymorphisms of one-carbon enzymatic mutation will cause one-carbon malnutrition of fetus, affecting fetal growth and modifying the risk of cancer development relationship of offspring. It is due to the lack of local ethnic data and empirical scientific reference at home and abroad, so it can not plan an effective maternal and children nutrient education and prevention strategies about methyl nutrition for early cancer prevention for Taiwanese. Therefore, indigenous people is the intended population of study in this project, screening of healthy pregnant women with high risk factor for cancer and obese pregnant women, and detection of one-carbon nutrient intake and biochemical assessment of the nutritional status of the study group. Supplying nutrition education intervention or multivitamin supplement to improve the poor nutritional status of persons. Using related DNA methylation imprint marker about offspring growth and modifying development of cancer as assessment, this project explores the appropriate one-carbon nutrient intake in parents and children and the assessments in regulation of growth and reducing the cancer-related risk.

Parental One-carbon Folate and Choline Nutrition Modulates Risk of Off-spring Cancer Development: Human Cohort Study

Using semiquantitative food frequency questionnaires (FFQ) to calculate dietary intake of one-carbon nutrient

Using 24 hours dietary recall and dietary record to calculate dietary intake of one-carbon nutrient

National Taiwan University Hospital

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

Tin Fluorides

Tyrosine Kinase Inhibitors

Tyrosine

Hong Liu, Doctorate

Lu Zhou, Doctorate

Hong N Liu, Doctorate

For patients with chronic myeloid leukemia in chronic phase (CML-CP) who have achieved a stable deep molecular response (DMR) using BCR-ABL1 tyrosine kinase inhibitors (TKIs), treatment-free remission (TFR) following TKI cessation is an emerging goal. However, about half of the patients relapsed after TKI discontinuation. There is no definite examinations to predict the outcome of TKI discontinuation. Investigators aim to study the relationship between FLOR3 SNP rs139130389 and the outcome of TKI discontinuation.

Investigators aim to detect FOLR3 SNP rs139130389, and establish its correlation with patients' treatment response, remission time, TKI resistance and the outcome of TKI stopping.

5ml Peripheral blood of CML patients who discontinued TKI treatment are extracted and stored.

FLOR3 Gene Polymorphism in Predicting Outcomes of Tyrosine Kinase Inhibitor（TKI）Stopping in Chronic Myeloid Leukemia

A Multicenter Prospective Cohort Study of FLOR3 Gene Polymorphism in Predicting Outcomes of TKI-stopping in Chronic Myeloid Leukemia

Observe whether the patients were in remission or relapse 1 year after drug withdrawal

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
N-PhenoGENICS: Neurocognitive-Phenome, Genome, Epigenome and Nutriome In Childhood Leukemia Survivors	NCT01913093	Childhood Leuke...		8 Years - 20 Years	The Hospital for Sick Children
Can B12 and Folate Levels Predict HPV Penetration in Patients With ASCUS?	NCT03903952	ASC-US Human Papilloma...	Vitamin B12 and...	30 Years - 65 Years	Sanliurfa Mehmet Akif Inan Education and Research Hospital
Phase 2 Trial of Bevacizumab in Combination With Pemetrexed	NCT00227019	Non-small Cell ... Lung Cancer Neoplasm Metast...	Bevacizumab Pemetrexed Vitamin B12 Folate Dexamethasone	18 Years -	Stanford University
Parental One-carbon Folate and Choline Nutrition Modulates Risk of Off-spring Cancer Development: Human Cohort Study	NCT02266641	Off-spring Canc...	nutrition couns... multivitamin su...	21 Years - 40 Years	National Taiwan University Hospital
FLOR3 Gene Polymorphism in Predicting Outcomes of Tyrosine Kinase Inhibitor（TKI）Stopping in Chronic Myeloid Leukemia	NCT05152537	Folate CML Treatment-free ...		18 Years -	Affiliated Hospital of Nantong University
Metformin and Folate in Pregnant Polycystic Ovary Syndrome(PCOS) Women	NCT01115140	Pregnancy Polycystic Ovar...	metformin plus ... Metformin plus ... placebo plus fo... placebo alone	18 Years - 38 Years	University Magna Graecia
Folate One-carbon Malnutrition as the Metabostemness Risk Factor of Malignancy Tumor Development of NSCLC Patients	NCT03504098	Lung Cancer, No...	nutrition consu...	20 Years - 90 Years	National Taiwan University Hospital
Folate One-carbon Malnutrition as the Metabostemness Risk Factor of Malignancy Tumor Development of NSCLC Patients	NCT03504098	Lung Cancer, No...	nutrition consu...	20 Years - 90 Years	National Taiwan University Hospital
Metformin and Folate in Pregnant Polycystic Ovary Syndrome(PCOS) Women	NCT01115140	Pregnancy Polycystic Ovar...	metformin plus ... Metformin plus ... placebo plus fo... placebo alone	18 Years - 38 Years	University Magna Graecia
CYTALUX™for the Intraoperative Imaging of Prostate Cancer	NCT06434909	Prostate Cancer	Cytalux™ (pafol...	18 Years - 90 Years	Indiana University

Spots Global Cancer Trial Database for folate

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

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