Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

A primarily African-American population living in the vicinity of a DDT production plant inAlabama.

Robert N Hoover, M.D.

This study will collect information on the height and weight of women who participated in a 1998 study in Triana, Alabama, on the risk of breast cancer and benign breast disease in relation to environmental exposure to the pesticide DDT and similar chemicals. This additional information is needed to calculate the participants' body mass index (BMI), which is required for completing analysis of the data.

The 1998 study-a collaborative effort of the National Cancer Institute, the Triana Area Medical Fund, and the College of Nursing at the University of Alabama at Huntsville-investigated possible effects of DDT and other compounds on the risk of breast cancer, predominantly among African-American women in the area of Triana, Alabama. The study was initiated as a result of medical findings showing high blood levels of DDT among the local population who had consumed fish from a tributary of the Tennessee River that had been polluted by the discharge over several decades of large quantities of pesticides from a DDT production plant.

Women participating in the study had a mammogram, physical examination, breast examination, and blood draw, and completed a questionnaire on diet and lifestyle factors. In order to complete analysis of the data and determine whether there is an association between environmental exposure to DDT and related chemicals and breast cancer risk, additional information on BMI is required.

A DDT production plant in Alabama discharged large quantities of the pesticide into the tributaries of the Tennessee River for several decades before it was discovered in the 1970's. A survey found that local primarily African-American, populations consuming fish from the river had accumulated body burdens of the chemical that were orders of magnitude above the general population. The settlement of law suits involving 1000 named plaintiffs by the Federal District Court in Birmingham, AL led to the development of the Triana Area Medical Fun, Inc. This fund provides 'health care and monitoring' for named plaintiffs as well as other residents of Triana who, as of August 1983, had not asked the Court for damages. The Board managing the activities of the Fund has given approval for this project.

The National Cancer Institute, in collaboration with the Triana Area Medical Fund and the College of Nursing at the University of Alabama in Huntsville, is conducting a study to investigate the possible effects of environmental exposures, such as the pesticide DDT and other organochlorines compounds, on the risk of breast cancer. Individuals covered by the Triana Area Medical Fund and other nearby residents were asked to participate.

The objective is to evaluate the risk of breast cancer associated with organochlorines exposures among predominatly African-American women. This project is comprised of two major components (1) comparison of blood serum levels of DDT, DDE and other organochlorines compounds among members of the Triana Area Medical Fund population with a high percentage of mammographic densities to women without this condition and (2) methodologic investigations on organochlorines retention/decay patterns within the well-characterized Triana Area Fund population.

The investigators offered mammographic screening to all women within the cohort over the age of 35 (about 350), as well as others who requested it. As a service to the participants, the investigators provided a standard clinical chemistry on blood samples and made the results available to the subject and their physician, if they so chose. If individuals did not have a regular physician, they were assisted in locating one to provide consultation and interpretation of examination results. Standard blood chemistries were performed locally in Alabama. The remainder of the blood sample was processed and sent to NCI for analysis and storage. Serum analyses were conducted by the National Center for Environmental Health at the CDC.

Results of the mammography, clinical examination and blood chemistries were provided to the participants in a manner agreeable to each. If the subject wished, the results were sent to her private physician. They made arrangements with several local hospitals to provide follow-up evaluation and therapy for women with breast diseases uncovered by mammography who lacked health insurance. Nurse practitioners or physicians involved in the study were available to discuss and explain results. For women who required additional diagnostic evaluation or therapy, they developed a follow back procedure to make sure appropriate actions are being taken.

Data collection is complete. Two hundred twenty eight women received mammograms, a physical examination, provided a serum sample (50 ml) and completed a questionnaire on diet and lifestyle factors. During the past year the investigators obtained information on height and weight, which is necessary to calculate body mass indices. Analyses of the data are underway and manuscripts are being developed.

Breast Cancer, Breast Disease, and Pesticides

A Study of Breast Cancer, Breast Disease, Mammographic Density and Pesticides Among a Population From Triana, Alabama

The objective is to evaluate the risk of breast cancer associated with organochlorines exposures among predominatly African- American women. This project is comprised of two major components (1) comparison of blood serum levels of DDT, DDE and other organochlorines compounds among members of the Triana Area Medical Fund population with a high percentage of mammographic densities to women without this condition and (2) methodologic investigations on organochlorines retention/decay patterns within the well-characterized Triana Area Fund population.

National Cancer Institute (NCI)

Heart and Blood Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Cardiotoxicity

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Bartosz Dąbek, MD

In the proposed project the investigators will asses whether changes in expression of selected circulating microRNAs in serum could comprise a sensitive and specific biomarker of cardiotoxicity in cancer patients treated with anthracyclines based chemotherapy.

Blood will be taken

1. before anthracycline based chemotherapy administration
2. at the middle of anthracycline treatment (before 3rd and/or 5th cycle of drugs infusion)
3. after anthracycline chemotherapy cessation
4. 6 months after chemotherapy cessation if an end point occurs
5. 12 months after chemotherapy cessation if an end point occurs

Echocardiography will be performed

1. before anthracycline based chemotherapy administration
2. after anthracycline based chemotherapy cessation
3. 6 months after anthracycline based chemotherapy cessation
4. 12 months after anthracycline based chemotherapy cessation if no end point was observed earlier The investigators will perform high-throughput miRNA(microRNA) expression profiling of serum samples - called training set.

Training set will consist of sera of 30 patients who has reached an end point. Training set will be sequenced using next generation sequencing.

Training set will be used to derive a miRNA signature capable of separating early cardiotoxicity patients from healthy ones. MiRNA signature will be validated using validation set.

5 ml of blood will be collected, 2ml of serum will be isolated from the blood and stored below -80C till completion of the study.

Circulating MicroRNA as Biomarker of Cardiotoxicity in Breast Cancer

Circulating microRNAs as a Novel Biomarker of Early Cardiotoxicity in Breast Cancer Patients Treated With Anthracyclines

either a cardiomyopathy with decreased left ventricular ejection fraction (LVEF), a reduction of LVEF ≥5% to \<55% with symptoms of heart failure (e.g. orthopnoea and paroxysmal nocturnal dyspnoea, elevated jugular venous pressure, S3 gallop, Hepatojugular reflux, tachycardia), or an asymptomatic reduction of LVEF ≥10% to \<55%

Pomeranian Medical University Szczecin

West Pomeranian Cancer Center

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

Patients are diagnosed with aggressive lymphoma including Hodgkin and non-Hodgkin lymphoma. All patients should receive systemic chemotherapy. Newly diagnosed or relapsed/refractory patients can be enrolled.

Systemic chemotherapy with curative intent

Chemotherapy

Seok Jin Kim, MD, PhD

Won Seog Kim, MD, PhD

Sivia Park, MD, PhD

This prospective study enrolls patients who are diagnosed with aggressive lymphoma including Hodgkin and non-Hodgkin lymphomas. Enrolled patients will be treated according to our institution' treatment policy in clinical practice. The disease status including response to therapy and survival status will be regularly updated during the study period. Patients' serum and cell-free DNA will be collected and analyzed.

The study population is aggressive lymphomas requiring systemic chemotherapy. Newly diagnosed or relapsed/refractory patients can be enrolled into the study. Patients can be treated according to the principle of routine care of our institute. The study process is as follows.

1. Registration after informed consent.
2. Laboratory and radiological evaluation after registration including collection of serum and cell-free DNA from patients' peripheral blood
3. Interim and final response evaluation including collection of serum and cell-free DNA from patients' peripheral blood
4. Regular monitoring disease status and update of survival status
5. Laboratory and radiological evaluation after relapse or progression including collection of serum and cell-free DNA from patients' peripheral blood

serum and cell-free DNA from patients' peripheral blood

Prospective Cohort Study for Lymphoma: Samsung Lymphoma Cohort Study III

A Prospective Study for Patients With Lymphoid Malignancy at the Samsung Medical Center

Time to relapse/progression or any kinds of death

Development of biomarker predicting response and survival outcome

Samsung Genomic Institute

Samsung Medical Center

All Drugs and Chemicals

Reproductive Control Agents

Hormones

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Estradiol

Polyestradiol phosphate

Progesterone

Estrogens

Hormone Antagonists

Progestins

measuring estradiol and progesterone levels in saliva

Blood levels of the hormones estradiol and progesterone are of interest in evaluating ovarian function. However, because these hormone levels vary from day to day, blood samples must be taken very often or elaborately timed to specific phases of the menstrual cycle. A method has now been developed for measuring estradiol and progesterone levels in saliva. This study will test the accuracy of this method and examine whether salivary levels of these hormones change after treatment with raloxifene.

Hormone levels will be measured during 3 menstrual cycles in women currently enrolled in the clinical study, "A Phase II Trial of Two Doses of Raloxifene in Women at Risk of Developing Invasive Breast Cancer." Participants will provide a saliva sample every morning for about a month during three collection periods-1 month before beginning raloxifene treatment, and 3 and 12 months after treatment starts. Patients will be given kits for collecting the samples and mailing them to the laboratory at the end of each collection period.

Deviations from normal levels of serum E(2) and P are of interest in evaluating ovarian function. However, the day-to-day variations in these levels necessitates serial blood sampling or elaborate efforts to time blood draws within specific phases of the menstrual cycle. A noninvasive method for assessment of the levels of sex steroids on a daily basis using saliva has been developed. This study will assess the levels of estradiol and progesterone during 3 menstrual cycles (pre-drug and after 3 and 12 months of raloxifene therapy) in pre-menopausal women participating in a pilot chemoprevention trial of raloxifene.

Effects of Raloxifene on Hormone Levels

Assessment of the Effects of Raloxifene on Salivary Estradiol and Progesterone Levels

Hyperemia

Heat Stress Disorders

Vascular Diseases

Follicle Stimulating Hormone

Complement System Proteins

Imidacloprid

Baseline measurements will be performed in the same schedule as measurements in the three other arms. In the baseline session, participants are in classroom before starting any firefighting exercise

Firefighting equivalent work, with exercises performed in a clean environment, without fire (no ambient temperature, soot or smoke). This type of exercise usually precedes or complements the training under real fire conditions.

Firefighting under wood fire, with exposure to ambient heat, smoke and soot. This is the most common training scenario used in the training centres. The participants will be in teams performing pre-defined tasks (knocking down the fire, moving heavy objects, and searching and rescuing metal stand in models

Firefighting under gas fire, with exposure to ambient heat, and expectably less smoke and soot than with wood fire. These conditions are used in some Danish training centres, with logistical advantages (ease of turning or putting out the fire and managing the fire fuel) and unknown effect relating to exposure prevention (smoke and soot). The participants will be in teams performing pre-defined tasks (knocking down the fire, moving heavy objects, and searching and rescuing metal stand in models

The participants will be performing firefighting equivalent work in a clean environment, without fire (no ambient temperature, soot or smoke).

Firefighting training exercises with no fire

The participants will be in teams performing pre-defined tasks (knocking down the fire, moving heavy objects, and searching and rescuing metal stand in models), under wood fire conditions.

Firefighting training exercises under wood fire

The participants will be in teams performing pre-defined tasks (knocking down the fire, moving heavy objects, and searching and rescuing metal stand in models), under gas fire conditions.

Firefighting training exercises under gas fire

Maria Helena G Andersen, PhD

Anne T Saber, PhD

Maria Helena Guerra Andersen

Epidemiological studies based on Danish registries have observed that Danish male firefighters have more cardiovascular disease, infertility diagnose and a trend to increased risk of cancer than other Danish employed males. Firefighting activities include a combination of stressors such as strenuous work under heat, smoke and soot known to be able to affect cardiovascular and reproductive health, with smoke and soot also being known to increase the risk of cancer.

The training facilities of real-fire extinguishing exercises in Denmark operate using wood or natural gas fire, which will have differential gradients of smoke, soot and possibly heat. The investigators will use different training conditions to create gradients of the different stressors and investigate health effects thereof. With this approach, the investigators expect to be able to evaluate the individual contribution of the different stressors in markers of cardiovascular, cancer and reproductive health risk. The project will include approx. 35 young conscript participants on a firefighting course, followed in four sessions, three firefighting training sessions under different fire conditions (no fire, wood fire and gas fire) and one control scenario.

The study methodology is based on a crossover design on firefighting training under different conditions, with characterization of exposure and assessment of cardiovascular, cancer and reproductive effect biomarkers. The study will be performed in cooperation with the Danish Emergency Management Agency.

The study will have one baseline session, while conscripts are in a classroom, and three sessions of firefighting-related exercises under different fire conditions, used currently in firefighting training programs in Denmark. The three firefighting training sessions will be controlled for equivalent work exercise using full protective gear and under different ambient conditions of firefighting training:

* Firefighting equivalent work (no fire), with exercises performed in a clean environment, without fire (no ambient temperature, soot or smoke). This type of exercise precedes or complements the training under real fire conditions.
* Firefighting under wood fire (wood fire), with exposure to ambient heat, smoke and soot. This is the most common training scenario used by Danish Emergency Management Agency training centres.
* Firefighting under gas fire (gas fire), with exposure to ambient heat, and expectably less smoke and soot than with wood fire. These conditions are used in some Danish training centres, with logistical advantages (ease of turning or putting out the fire and managing the fire fuel) and unknown effect relating to exposure prevention (smoke and soot).

The order of the firefighting sessions will be as randomized as possible, and according to a selection of three sequence order options (no-wood-gas; wood-gas-no and gas-wood-no). Each campaign (corresponding to each rescue course) would desirably have one of these session sequences. It is not possible to blind the participants to the different scenarios, neither the field staff, but all the samples will be blinded for the subsequent laboratory analysis. The training sessions will have 1-3 weeks in between (accordingly with programmatic educational course schemes).

Participants will perform firefighting full day exercises under 3 different conditions (without fire, under wood fire and under gas fire), sessions which will occur with weeks in between, and biological markers will be assessed and compared in relation to a baseline session, where the participants are having theoretical classes.

It is not possible to blind the participants to the different scenarios, neither the field staff, but all the samples will be blinded for the subsequent laboratory analysis, namely blood analysis, urine analysis, wipe samples analysis will all be blinded.

Effect on Markers of Cardiovascular, Reproductive and Cancer Risk From Firefighting Training

Effect on Markers of Cardiovascular, Reproductive and Cancer Risk From Firefighting Activities - a Study Under Different Training Methods

Supportive information and fully anonymized information will be shared and whenever possible (in supplementary material) published along with the results, but following European Union General Data Protection Regulation (GDPR) and Danish rules, no non or pseudo anonymized data might be shared.

Reactive hyperemia index (RHI) measured with the device EndoPAT 2000. A reactive hyperemia is induced by a blood cuff on the upper arm and the peripheral vasodilation response is assessed in the small digital vessels of a fingertip with a portable device connected to a computer, with RHI determined by an algorithm from the device, with lower index values corresponding to a worsen situation.

Heart rate variability (HRV) measured with the device EndoPAT 2000. The HRV is calculated using the initial 5.5 complete minutes before the cuff is applied. pNN50 is the proportion of successive NN intervals differing by more than 50 milliseconds divided by the total number of N intervals (given in percentage).

Heart rate variability (HRV) measured with the device EndoPAT 2000. The HRV is calculated using the initial 5.5 complete minutes before the cuff is applied. RMSSD is the square root of the mean squared differences of successive NN intervals (given in milliseconds)

Heart rate variability (HRV) measured with the device EndoPAT 2000. The HRV is calculated using the initial 5.5 complete minutes before the cuff is applied. Ratio of low frequency and high frequency bands

Oxidized nucleobase 8-oxodG will be measured in urine samples by High-performance liquid chromatography (HPLC) as marker of oxidative stress, together with creatinine, for adjusting for urine concentration. Data will be reported as nanomol 8-oxodG per millimol creatinine.

DNA strand breaks will be measured by comet assay, and reported as number of lesions per 10\^6 base pairs, transformed from percentage of DNA in tail using the calibration curve from the well-establish relationship between ionizing radiation dose and yield of strand breaks in DNA.

Core body temperature will be assessed by an ingestible pill thermometer with data recorded and reported as time series during the period in transit.

Scrotal temperature will be assessed by skin sensor placed in the scrotum of male participants and reported as scrotal skin temperature time series.

Core body temperature will be assessed by an ingestible pill thermometer and scrotal temperature will be assessed by skin sensor placed in the scrotum of male participants, to assess the thermoregulation of the scrotum during firefighting exercises. Time series of core body temperature and scrotal skin temperature will be analysed for eventual thermoregulation disruption.

Circulating micro RNA candidates will be measured by RNA extraction from serum samples, reverse transcribed into complementary DNA (cDNA) and analysed with quantitative polymerase chain reaction (qPCR).

The aryl hydrocarbon receptor (AhR) activation will be assessed in vitro using urine samples on the PAH CALUX (Chemical Activated LUciferase gene eXpression bioassay) reporter assay. The smoke and soot exposures are complex mixtures of compounds with potential toxic effect. Routine measurements of PAHs are usually quantified for a target list of 16 common soot elements and even less chemical species for urinary metabolites, but many other compounds are present in both soot and metabolites mixtures. The toxicity of PAHs is primarily caused through the binding to AhR, and induction of AhR related genes and subsequent toxic pathways. The outcome will be measured in the form of benzo\[a\]pyrene equivalence.

The aryl hydrocarbon receptor (AhR) activation will be assessed in vitro using wipe samples on the PAH CALUX (Chemical Activated LUciferase gene eXpression bioassay) reporter assay. The smoke and soot exposures are complex mixtures of compounds with potential toxic effect. Routine measurements of PAHs are usually quantified for a target list of 16 common soot elements, but many other compounds are present in soot mixtures. The toxicity of PAHs is primarily caused through the binding to AhR, and induction of AhR related genes and subsequent toxic pathways. The outcome will be measured in the form of benzo\[a\]pyrene equivalence.

Follicle-stimulating hormone (FSH) will be measured in serum samples

Inhibin B hormone will be measured in serum samples

The internal dose of polycyclic aromatic hydrocarbons (PAHs), that would have the contribution from different exposure routes, will be assessed in first morning urine samples and measured for 7 isomer hydroxyl-PAH compounds and 5 nitro-PAH compounds, measured by high-performance liquid chromatography (HPLC)

Skin wipes will be sampled to determine the PAH composition of deposited soot on the neck area. The wipes will be analysed for the 16 US Environmental Protection Agency priority list of PAH compounds by HPLC.

Lung function will be measured by spirometry using the Spirometer device EasyOne Air. Forced Expiratory Volume at 1 second (FEV1).

Lung function will be measured by spirometry using the Spirometer device EasyOne Air. Forced Vital capacity (FVC).

Lung function will be measured by spirometry using the Spirometer device EasyOne Air. Peak Expiratory Flow (PEF).

Lung function will be measured by spirometry using the Spirometer device EasyOne Air. Forced Expiratory Volume at 1 second (FEV1) and Forced Vital Capacity (FVC) ratio is calculated from device output.

Cardiac troponin levels using ELISA immunoassays will be assessed in serum samples.

Muscle activity will be assessed to control for body workload through electromyography (EMG) using the portable device Nexus10. Bipolar surface EMG electrodes are applied to the skin over the muscles in 3 relevant body regions (shoulder, leg and back). The signals are collected with a data logger and reported as work load during a working day.

University of Copenhagen

University Hospital Bispebjerg and Frederiksberg

Rigshospitalet, Denmark

National Research Centre for the Working Environment, Denmark

Mouth and Tooth Diseases

Lichen Planus

Mouth Neoplasms

Precancerous Conditions

Leukoplakia

Lichenoid Eruptions

Exanthema

Skin Diseases, Papulosquamous

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Pathological Conditions, Anatomical

Oral Cancer

Lip and Oral Cavity Cancer

patients suffering from oral squamous cell carcinoma

patients diagnosed with potentially malignant lesions such as leukoplakia, and dysplastic erosive or atrophic oral lichen planus

Participants were told to cease smoking, eating, or drinking before the collection of samples by about half an hour. Obtaining the sample was done by demanding the individual to swallow then incline his head forward to expectorate saliva in a sterile tube for about 3 min. Afterwards the samples were coded by serial numbers then stored at -20°C until being assessed.

Under aseptic circumstances and using plain tubes, 5ml peripheral venous blood samples were collected from all participants by standard venipuncture. Samples were transported to biochemistry laboratory and centrifuged followed by filtration of the clarifying supernatant and then stored at -20ºC

serum and unstimulated salivary samples

Nayroz Tarrad, associate professor

Aim: The current study targets linking serum and salivary dipeptidyl peptidase-4 with oral squamous cell carcinoma and comparing it with potentially malignant lesions and control to validate dipeptidyl peptidase-4 as a diagnostic marker for early detection of oral cancer and to reveal its possible role in carcinogenesis.

Methodology: A total of 45 patients were recruited and subdivided into 2 groups: Group I: 15 patients having oral squamous cell carcinoma. Group II: 15 patients with potentially malignant lesions (leukoplakia and oral lichen planus) compared to 15 systemically healthy participants having no oral mucosal lesions acting as a control group (Group III). Serum and whole unstimulated salivary samples were collected from all participants to evaluate dipeptidyl peptidase level in different groups using enzyme linked immune-sorbent assay (ELISA) kit. ROC analysis was done to reveal area under the curve, sensitivity, specificity and diagnostic accuracy of DPP-4 among different groups.

Dipeptidyl Peptidase-4 Link With Oral Cancer and Premalignant Lesions

Association of Serum and Salivary Dipeptidyl Peptidase-4 (DPP-4) With Oral Cancerous and Precancerous Lesions; an Observational Diagnostic Accuracy Study

level of DPP-4 is measured in all collected serum and salivary samples

Fayoum University

associate professor

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Communicable Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Lymphoma, AIDS-Related

Lymphoma, B-Cell

B-cell Lymphoma

Non-Hodgkin's lymphoma (NHL) is the third most rapidly increasing cancer in the United States. HIV-related NHL is responsible for some of the increase since the early 1980s. However, it cannot explain the steady increase in the incidence rates in earlier years, nor the entire increase shown recently. A possible role of environmental exposures is receiving attention. One possibility is that exposure to organochlorines (OCs) may be related to the occurrence of NHL. NCI is currently designing a large population-based case-control study to investigate this hypothesis further by analyzing OC levels in blood collected at the time of interview from cases of NHL and their matched controls. At the time of these interviews, cases in the main case-control study would most likely have already received chemotherapy. If chemotherapy changes the blood levels of OCs, this may lead to misclassification of exposure among cases and eventually to biased risk estimates. The purpose of this pilot study is to estimate the bias due to measuring the serum levels of OCs in cases during or after chemotherapy. Twenty newly diagnosed patients will be recruited for the study. From each patient, four consecutive blood samples, one prior to, two during, and one after chemotherapy, will be collected. Forty pairs of pre-existing cryopreserved serum samples (pre- and post-treatment) taken from the NHL patients who participated in an earlier NCI clinical study will also be included in this study. Samples will be assayed for OC levels. The results will be used to plan and to interpret another large case-control study (the main study).

A Pilot Study of Non-Hodgkin's Lymphoma: Chemotherapy and Blood Levels of Organochlorines

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms, Squamous Cell

The study group is composed by patients with a condition that requires a procedure/surgery for oral squamous cell carcinoma treatment.

INTERVENTIONS: Collect blood, saliva and oral tissue.

Group without oral squamous cell carcinoma but with a condition that requires prosthetic procedure/surgery.

INTERVENTIONS: Collect blood, saliva and oral tissue.

Adriana Demathe, PhD

Glauco I Miyahara, PhD

Human papillomavirus (HPV) is one of the most prevalent infections in the world with several millions of new cases diagnosed yearly. Oral HPV infection may be associated with different diseases of oral cavities including some cases of oropharyngeal cancer.

The aim of this report is to detect the presence of HPV DNA in samples of biopsies, oral swabs, saliva and serum of patient with oral squamous cell carcinoma (OSCC) and controls. We hoped to find there is correlation among the presence of HPV DNA in the several biological materials and if it is possible to use the saliva as screening to HPV DNA detection. The presence of tumor HPV DNA in blood may be of diagnostic and prognostic value.

This study will made at the buccal cancer center of UNESP and involved forty patients (n = 40) and forty controls. Serum samples, oral swabs and saliva will collect at the date of diagnosis before therapy and will store at -80 ºC until analysis. Formalin-fixed paraffin-embedded oral squamous cell carcinoma tissues and other biologic samples will process with phenol/chloroform extraction method.

Tumors from 40 OSCC patients at the UNESP University will be obtained from biopsy with prior consent, along with corresponding venipuncture blood, saliva collection and exfoliated buccal cells samples. From controls will be obtained all samples except biopsy tissues. Clinical information including tumor location, stage, and nodal status will be recorded.

Clotted blood specimens will be centrifuged at low speed for 5 min, and the serum was stored at - 80 °C before DNA extraction. Serum samples (400 ml) will be used for DNA extraction. Whole saliva and exfoliated buccal cells will be digested in proteinase K at 48°C during two hours, serum and tumor tissue samples will be digested in proteinase K at 48°C overnight, followed by phenol/chloroform extraction and ethanol precipitation of DNA for all samples. After resuspension in 50 ml of distilled water, the mean working DNA concentrations will be 100-150 ng/ml per serum and tissues samples and 30-50 ng/ ml per whole saliva and exfoliated buccal cells samples. For beta-globin PCR will be used 150 to 300 ng of purified total cellular DNA, to assess the quality of the DNA using the PCR primers GH20 and PC04. After confirmation of the presence and integrity of genomic human DNA, the same amount of DNA will be testing for HPV DNA by nested polymerase chain reaction (PCR) in all samples. In first PCR round degenerate consensus primers MY11 and MY09 will be using to amplify fragments of 450 bp. HPV DNA will amplified in a second round by GP5+ and GP6+ primer sets. The other reaction components will be: 10.9 microlitres of ultra-pure water, 2.5 microlitres PCR buffer 10X, 4mM MgCl2, 15 pmol dNTPs and 1 unit of Platinum Taq DNA polymerase. Approximately 150-300 ng of genomic DNA from each sample will be add to the mixture. The same amount of Hela cells, with up to 4 copies of HPV-18 per cell, will be used as positive control for HPV infection. The negative control will be composed by all PCR components except DNA. The mixture underwent initial denaturation to 94ºC for 10 min, before 40 PCR cycles (94ºC for 1 min; 55ºC for 1 min; 72ºC for 40) and 72°C for 4 minutes. For nPCR, two microliters of the product from the first reaction will be used directly in a reaction containing: 0,02 mM of each primer GP5+ and GP6+(Invitrogen Life Technologies®, Brazil), which produce a 150 pb DNA fragment. The remaining reaction components and conditions will be as described for the first round of PCR, except for the annealing temperature that will be reduced to 43ºC. Ten microliters of the nPCR products will be fractionated by electrophoresis in a 8% polyacrylamide gel, for 3 hours at 100 volts. Band visualization will be performed by staining with silver nitrate solution. Samples will be scored as either HPV DNA-positive or negative based on the inspection of silver nitrate stained bands. PCR amplification will be performed in triplicates for each sample. Samples will be classified as positive or negative based on gel analysis.

Differences in proportion will be evaluated by means of Fisher's exact test. A P value of less then 0.05 will be considered statistically significant. These statistical calculations will be performed using SPSS, version 10.0, for Windows.

This biospecimens will be retained: whole blood, exfoliated cells, saliva and formalin-fixed paraffin-embedded tissues.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Breast Cancer, Breast Disease, and Pesticides	NCT00341315	Breast Cancer		35 Years - 80 Years	National Institutes of Health Clinical Center (CC)
Breast Cancer, Breast Disease, and Pesticides	NCT00341315	Breast Cancer		35 Years - 80 Years	National Institutes of Health Clinical Center (CC)
Circulating MicroRNA as Biomarker of Cardiotoxicity in Breast Cancer	NCT02065908	Breast Cancer		18 Years - 70 Years	West Pomeranian Cancer Center
Prospective Cohort Study for Lymphoma: Samsung Lymphoma Cohort Study III	NCT03117036	Lymphoma, Non-H... Lymphoma, Hodgk...	Chemotherapy	20 Years - 90 Years	Samsung Medical Center
Effects of Raloxifene on Hormone Levels	NCT00026962	Breast Cancer	measuring estra...	-	National Institutes of Health Clinical Center (CC)
Effect on Markers of Cardiovascular, Reproductive and Cancer Risk From Firefighting Training	NCT05753254	Reactive Hypere... Micro RNA Heart Rate Vari... DNA Strand Brea... Oxidative Stres... Heat Stress	Firefighting tr... Firefighting tr... Firefighting tr...	18 Years -	National Research Centre for the Working Environment, Denmark
Dipeptidyl Peptidase-4 Link With Oral Cancer and Premalignant Lesions	NCT06087042	Oral Premaligna... Oral Cancer	serum and unsti...	30 Years - 65 Years	Fayoum University
Prospective Cohort Study for Lymphoma: Samsung Lymphoma Cohort Study III	NCT03117036	Lymphoma, Non-H... Lymphoma, Hodgk...	Chemotherapy	20 Years - 90 Years	Samsung Medical Center
A Pilot Study of Non-Hodgkin's Lymphoma: Chemotherapy and Blood Levels of Organochlorines	NCT00001571	HIV Infections Lymphoma, AIDS-... Lymphoma, Non-H...		-	National Institutes of Health Clinical Center (CC)
Human Papillomavirus on Oral Tissue, Saliva and Serum	NCT01043328	Squamous Cell C...		30 Years - 85 Years	UPECLIN HC FM Botucatu Unesp
Dipeptidyl Peptidase-4 Link With Oral Cancer and Premalignant Lesions	NCT06087042	Oral Premaligna... Oral Cancer	serum and unsti...	30 Years - 65 Years	Fayoum University
Effect on Markers of Cardiovascular, Reproductive and Cancer Risk From Firefighting Training	NCT05753254	Reactive Hypere... Micro RNA Heart Rate Vari... DNA Strand Brea... Oxidative Stres... Heat Stress	Firefighting tr... Firefighting tr... Firefighting tr...	18 Years -	National Research Centre for the Working Environment, Denmark

Spots Global Cancer Trial Database for serum

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

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