Symptoms and General Pathology

All Conditions

Rare Diseases

Disease Susceptibility

Chromosome Aberrations

Oculocerebral Syndrome With Hypopigmentation

Qing Lan, M.D.

Background:

* Trichloroethylene (TCE) is a solvent used in many medical and industrial processes.
* TCE is a carcinogen (causes cancer) in rats, but its carcinogenicity in humans is unclear. There is some evidence of increased liver and kidney cancers and of an association with non-Hodgkin lymphoma in studies of workers exposed to TCE.
* The carcinogenicity and regulation of TCE is a matter of continuing debate.

Objectives:

* To determine if TCE exposure is associated with higher levels of genetic aberrations in certain white blood cells called lymphocytes.
* To determine if TCE exposure affects lymphocyte subsets and levels of certain hormones called cytokines.

Eligibility: Workers exposed to two different levels of exposure to TCE and unexposed workers in Guangdong Province, China.

Design:

* 45 workers exposed to more than 25 parts per million (ppm) TCE, 30 workers exposed to from 10 to less than 25 ppm TCE and 45 unexposed workers will be enrolled.
* Subjects wear small instruments at work that measure chemicals in the air for 1 or 2 days during the 2-week study period. Exposed workers also wear several small skin patches on one of the two days.
* Subjects provide blood and urine samples.
* Subjects answer a questionnaire about work, smoking and drinking, use of medicines, medical history, general health, hobbies, and exposure to radiation and exposure to various substances at home.

Trichloroethylene (TCE) is an industrial solvent used in degreasing, dry cleaning, and numerous other medical and industrial processes. It is a ubiquitous environmental contaminant of drinking water and is present in many EPA Superfund sites. TCE is a rodent carcinogen but its carcinogenicity in humans is unclear. There is some evidence for an elevation in liver and kidney cancers and somewhat more convincing evidence of an association with non-Hodgkin lymphoma (NHL) in epidemiological studies of occupationally exposed cohorts. Overall, the carcinogenicity of TCE and its regulation is a matter of continuing debate despite an extensive database of in vitro and in vivo animal studies and several cohort and case-control studies. IARC categorizes TCE as a probable human carcinogen. In order to address questions about TCE's potential carcinogenicity and mechanism of action in humans, we propose to conduct a cross-sectional study of early biologic effect biomarkers of genotoxicity and immunotoxicity in 45 workers exposed to greater than 25 ppm TCE, 30 workers exposed to 10-25 ppm TCE, and 45 unexposed controls in Guangdong Province, China. We will assess TCE exposure level quantitatively, collect other exposure information through a questionnaire, collect biological samples, and assay a series of biomarkers of susceptibility, intermediate and early biologic effects. Our primary goal is to determine if TCE exposure increases chromosomal aberrations in peripheral lymphocytes, with a secondary goal of determining if TCE alters levels of key cytokines in plasma and changes lymphocyte subset ratios. In addition, our collaborators at UC Berkeley will apply a new generation of cytogenetic and molecular techniques to study TCE's ability to cause specific types of chromosomal aberrations that have been associated with NHL and related hematological malignancies as well as the impact of TCE on mRNA expression and the proteome. The work will compliment previous and ongoing OEEB studies of populations exposed to TCE and has the potential to make an important contribution to what little is known about the early biologic effects of TCE in humans.

Plasma, Red blood cells, whole blood, cryopreserved lymphocytes, cryopreserved granulocytes, FISH cells, FISH slides, RNAlater, supernatant, buccal pellets, buccal slides, serum, clot, LeukLock, buffy coat, urine.

Cancer Markers Associated With Occupational Exposure to Trichloroethylene

A Cross-Sectional Study of Occupational Exposure to Trichloroethylene, Chromosomal Aberrations, and Related Biomarkers in Guangdong, China

The primary goal of the study is to determine if TCE exposure is associated with higher levels of chromosomal aberrations in peripherallymphocytes. The additional goals of the study, to be funded by extramural collaborators, are to evaluate TCE urinary metabolite patterns, alterations in specific types of chromosomal aberrations that have been detected in NHL and other hematopoietic malignancies, and alterations in mRNA expression and the proteome.

A secondary goal of the study is to determine if TCE exposure alters plasma cytokine levels and lymphocyte subsets.

National Cancer Institute (NCI)

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Paclitaxel

Cyclophosphamide

Carboplatin

Albumin-Bound Paclitaxel

Cisplatin

Patients that received at least one of the following treatments: Carboplatin, Cisplatin, Cyclophosphamide, Paclitaxel and/or anthracyclines, the latter being the most given type of CT during pregnancy

Women who were not treated with CT during pregnancy, including those who were solely surgically treated or did not receive any treatment during pregnancy, will be included in the CT-unexposed control arm

A group of healthy pregnant women without cancer will form the second control group

Ilana Struys

Liesbeth Lenaerts, PhD,Ir

Frédéric Amant, MD,PhD

Kristel Van Calsteren, MD,PhD

Bernard Thienpont, PhD,Ir

Lode Godderis, MD,PhD

Thierry Voet, PhD,Ir

The investigators want to obtain a fundamental understanding if and which chemotherapeutic agents used for treating cancer during pregnancy are associated with placental and/or offspring (epi)genetic changes, potentially causing FGR and childhood/adult diseases later in life.

Rationale: Cancer is the second leading cause of death during the reproductive years and affects between 1:1000 and 2000 pregnant women. Previous studies from our group have shown that chemotherapeutic cancer treatment in pregnancy has reassuring outcomes in terms of cognitive and cardiac neonatal outcomes, and hence has been proposed as standard of care. However fetal growth restriction (FGR), which places an infant at significant risk of perinatal morbidity and mortality, is more common in women who were systemically treated during pregnancy compared to the non-cancer population. The possibility that chemotherapy during pregnancy causes placental (epi)genetic damage, and consequently induces FGR, or affects offspring DNA leading to potential deleterious effects later in life, such as cancer or other diseases, has not been investigated so far. As the cytotoxic effects of chemotherapy at DNA level have been well established, it could be speculated that chemotherapy-induced DNA damage may interfere with fetal and childhood health in the long term. The results of this study will lead to an increased understanding of potential toxic effects of chemotherapy for the unborn child and may therefore contribute to the development of safe and solid treatment regimens for pregnant cancer patients and their children.

Objectives: To obtain a fundamental understanding if and which chemotherapeutic agents used for treating cancer during pregnancy are associated with offspring (epi)genetic changes, potentially causing FGR and childhood/adult diseases later in life.

Study design: This international multicentre prospective observational trial functions as an extension of the CIP-study (Cancer in Pregnancy, S25470) and aims to collect cord blood, meconium and neonatal buccal cells at birth. Parental peripheral blood and buccal cells will be collected and used as reference. Minimal requirement to participate in this study is participation in Part I.IA of the original CIP-study. Through this CIP-study we are able to gather pregnancy-, malignancy- and placenta-related data.

Study population: All patients with histological proven cancer during pregnancy and an ongoing pregnancy (≥24 weeks of gestation) treated with chemotherapy (alkylating agents, anthracyclines, taxanes and/or platinum derivates) or other treatment options (surgery, radiotherapy and/orsystemic treatment other than chemotherapy, or none).

Main study parameters/endpoints: determination of potential (epi)genetic alterations in cord bloodand buccal cells of the newborn, and the association with chemotherapy concentrations measured in newborn tissue.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no risks associated nor benefits expected with participation in this study.

Parental blood, cord blood, meconium, buccal swabs

Genomic and Epigenomic Alterations After Cancer Treatment in Pregnancy

somatic mutations, structural alterations, methylation changes

University Hospital, Antwerp

University Hospital, Ghent

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

University Hospital, Gasthuisberg

Clinical Professor, Principal Investigator

Neoplasms

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

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
Cancer Markers Associated With Occupational Exposure to Trichloroethylene	NCT00481611	Industrial Hygi... Epidemiology Neoplasms		18 Years - 50 Years	National Institutes of Health Clinical Center (CC)
Genomic and Epigenomic Alterations After Cancer Treatment in Pregnancy	NCT04125446	Cancer Pregnancy		-	University Hospital, Gasthuisberg
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

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