saliva samples

blood samples

Carole Rubino, MD

Nadia Haddy, MD

The constitution of a biological samples bank, attached to epidemiological studies Cohort F-CCSS on iatrogenic effects of treatment of childhood cancer, will identify genetic variants that can modulate the iatrogenic risks of these treatments. The main objective is to provide a biological samples bank to consider, besides the carcinogenic risks, the risk of other iatrogenic diseases in these children, in particular cardiac, cerebrovascular, lung, bone and kidney. These conditions can be very incapacitating and in some cases, fatal. Their impact, however, is poorly estimated as occurring in adulthood, they are rarely made in relation to the treatment received in childhood. The overall project is expected to eventually better define the iatrogenic effects prevention strategies for cancer treatment.

Iatrogenic Effects of Treatment for Childhood Cancer Constitution of a Biological Samples Bank

Study of Iatrogenic Effects of Treatment for Childhood Cancer - Constitution of a Biological Samples Bank as Part of a Cohort of Patients (Cohort FCCSS)

Gustave Roussy, Cancer Campus, Grand Paris

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Melanoma

Melanoma, Cutaneous Malignant

Nevus, Pigmented

Nevus

Nevi and Melanomas

Neoplasms by Histologic Type

Participants at high-risk for melanoma (that is, those having many nevi and morphologically atypical nevi) who either have a history of invasive melanoma (cases) or do not have a history of melanoma (controls) and will perform comprehensive total body imaging of their moles in order to identify phenotypic markers of melanoma risk that aid in melanoma risk stratification. In addition, we will investigate histopathologic and molecular features of moles that are associated with melanoma risk and with melanoma subtypes. The evaluations needed for this study protocol will be primarily performed during routine clinical care.

Research assessments as part of this protocol will be scheduled during routine clinic visits

survey

Saliva samples

Allan Halpern, MD

The investigators are doing this study to improve our ability to identify which people with many moles on their skin are most likely to develop skin melanoma. The investigators hope to identify features of moles that are associated with melanoma risk. The investigators hope to use this information to customize and tailor melanoma screening to the individual patient based on a better estimate of their individual risk.

Risk Stratification Among Individuals Who Have Many Moles on Their Skin

Cutaneous Melanoma Risk Stratification of Individuals With a High-Risk Nevus Phenotype

For each person, the proportions of their nevi having specific dermoscopic patterns will be calculated.

Princess Alexandra Hospital, Brisbane, Australia

Sheba Medical Center

Tel-Aviv Sourasky Medical Center

Memorial Sloan Kettering Cancer Center

Blood and Lymph Conditions

Hematologic Neoplasms

Hematologic Diseases

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Antineoplastic Agents

Chrysarobin

Immunoglobulins, Intravenous

Ibrutinib

gamma-Globulins

Rho(D) Immune Globulin

Idelalisib

Bilirubin

Protein Kinase Inhibitors

Interventions to be administrated are :

* Clinical examinations
* Biological statement
* Blood samples for pharmacokinetics exploration
* Imagery with positron emission tomography scan or resonance magnetic imagery
* Saliva samples for genetics analyses
* Blood samples for treatment mutation resistance search
* Quality of life scale questionary
* Detection of adverse events

Blood samples for pharmacokinetics exploration

Efficacity will be assessed with 3 sessions of resonance magnetic imaging or positron emission tomography scan

Imagery

Quality of life will be evaluated with questionaries 5 times during the study

Quality of life scale

The detection will be assessed using the AMA (assistance des malades ambulatoires) system

Detection of adverse events

Saliva samples will be collected to explore genetic characteristics of germinal DNA (genes involved in drug pharmacokinetic)

A unique blood sample will be performed in order to determine characteristics of tumoral DNA (resistance to treatment mutation)

Blood sample

The following parameters will be assessed :

* Complete blood count
* Hemoglobin
* Hepatic enzymes
* Creatinine clearance
* Lactate dehydrogenase rate
* Total bilirubin rate
* Cluster of differentiation 4 T lymphocytes rate
* Total gamma-globulins rate

Biological statement

The clinical examination are composed by :

* Weigh, Height and body mass index measurement
* Clinical state of patient during examination
* Stage of the disease (OMS grade, binet classification, Ahn Arbor classification)
* Presence of B symptomatology
* Prognostic factors (Genetic, Mantle Cell Lymphoma International Prognostic Index, Follicular Lymphoma International Prognostic Index, presence of lymph nodes, other target organs ...)

Clinical examination

Loïc Ysebaert, MD

Recently, European Medicines Agency approved ibrutinib and idelalisib to treat Chronic Lymphocytic Leukemia (CLL) and two lymphomas: Follicular Lymphoma (FL) for ibrutinib and Mantle cell lymphoma (MCL) for idelalisib.

Clinical trials for ibrutinib and idelalisib were performed with a small number of patients (300-350) and showed several side effects profiles. Since, pharmacokinetic properties of these 2 drugs highlight a interindividual variability of pharmacokinetic. The aim of this study is to determine the association between clinically significant side effects occurrence during the first year of treatment and plasma mean concentration of the steady state of ibrutinib or idelalisib at 1 month.

Recently, European medicines agency approved ibrutinib and idelalisib in the treatment of Chronic Lymphocytic Leukemia (CLL) and two lymphomas: Follicular Lymphoma (FL) for ibrutinib and Mantle cell lymphoma (MCL) for idelalisib. Nevertheless, clinical trials for these two drugs were performed for only 300-350 patients and showed several side effects profiles, the most frequent were diarrhea, infection, cutaneous rash... For some patients, treatment had to be reduced or stopped temporary or definitely.

Pharmacokinetic properties of these two drugs highlight an interindividual pharmacokinetic considerable variability. The aim of this clinical research study is to determine the association between clinically significant side effects occurrence during the first year of treatment (serious adverse reaction and/or grade CTCAE ≥ 3 and/or leading a dosage concession) and plasma mean concentration of the steady state of ibrutinib or idelalisib performed at 1 month.

To determine plasma mean concentration of the steady state of ibrutinib or idelalisib, blood tests will be performed every scheduled monitoring at visit 1 month during a pharmacokinetic exploration and during scheduled medical consultation (2, 3, 6 and 12 months) and every unscheduled visit in case of side effect occurrence.

Every scheduled monitoring visit, blood tests will be performed to determine plasma concentration in drug. Complementary blood or salivary samples will be collected before the treatment, 24 months later and in case of relapse to determine genetic characteristics. In parallel, a logbook will be completed by the patient to collect side effects. Finally, an oncology certified nurse call patients every 2 weeks. In case of side effect occurrence a visit will be organized in the next 3 days and a blood test will be performed.

Samples to be collected are :

* Blood samples for dosage of drug in plasma (No DNA)
* Blood samples (genetic profile of drug elimination and presence of treatment resistance mutation) and saliva samples (genetic profile drug elimination )

Association Between Side Effects Occurrence and Concentrations of Ibrutinib and Idelalisib

Real Life Assessment of the Association and Its Determinants Between Side Effects and Plasmatic Concentrations of Two Protein Kinase Inhibitors: Ibrutinib (IMBRUVICA®) and Idelalisib (ZYDELIG®) in Hematological Malignancies Treatment.

Plasma balance mean will be calculated with 6 blood samples collected at regular intervals during the visit

complete response, partial, stable disease, disease progression

University Hospital, Toulouse

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Aggression

Prostatic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Participants will be asked to complete a baseline questionnaire that asks questions about their demographic information, medical history, and smoking habits when they first enroll in the study. They will also be asked to complete a follow-up questionnaire 2 years later. The questionnaires will each take about 25 minutes to complete.

Questionnaires

Participants will be asked to provide a saliva sample using the saliva kit that will be mailed to them. Detailed instructions for collection will be included in the saliva collection packet.

Saliva Samples

Participants will be asked for permission to obtain a sample of their tumor tissue. Participants will receive a medical release form. Once they complete it and mail it back, investigators will request a small amount of tissue collected during the participant's prostate biopsy (or during their surgery, if they had surgery) from their health care provider.

Tumor Tissue

Jong Park, Ph.D.

The purposes of this study are: a) to develop a statewide Biobank for prostate cancer among men of African Ancestry in Florida and; b) to examine whether smoking increases the aggressiveness of prostate cancer using several biological approaches.

Investigators plan to contact African American prostate cancer patients regarding participation. This project has 3 main components. Eligible patients may choose to participate in any or all parts of the study: Questionnaires; Saliva Samples; Tumor Tissue.

This project will create the first state-wide data and biospecimen bank for men of African ancestry with prostate cancer. The sampling strategy and size of the study population ensure that the cohorts is representative, enhancing validity of studies based on this resource. In addition, there are no data on the role of smoking in African American prostate cancer. The approach to share the resource with Florida prostate cancer researchers is innovative and possible because the four annual prostate cancer symposiums organized by Moffitt has unified many Florida prostate cancer researchers who are now well connected and actively collaborating, as evidenced by publications and funded projects among participants.

Biobank for African American Prostate Cancer Research in Florida

The study timeline is up to 3 years to collect detailed patients' data, outcome information and bio-specimens from men of African Ancestry with prostate cancer (n=6,000), diagnosed between January 2013 and December 2015.

Rate of prostate aggressiveness according to the smoking status (never, former, current cigarette smoker, pipe/cigar smoker only) at the time of diagnosis. This smoking status can be dichotomized into current smoker and non-smoker.

Current smokers further will be classified according to the Pack-year which will be obtained from questionnaire.

Occurrence of genetic changes associated with smoking and aggressiveness in prostate tumor samples. Investigators selected \~200 mutations identified in 12 prostate-cancer related genes (AR, ETS, TP53, PTEN, APC, BRAF, BRCA2, ATM, KRAS, SPOP, ERG and EGFR) based upon preliminary study and literature search. Investigators will perform mutation detection on randomly selected 200 patients and determine their association with aggressiveness and smoking.

Occurrence of epigenetic changes associated with smoking and aggressiveness in prostate tumor samples. A customized panel of 384 CpG sites will be profiled. 384 candidate CpG sites were selected from 149 sites including 18 multiple differentially methylated regions (DMRs) identified in the preliminary study, 235 sites from previous literatures. Investigators will determine their association with aggressiveness and smoking.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Iatrogenic Effects of Treatment for Childhood Cancer Constitution of a Biological Samples Bank	NCT02666625	Paediatric Mali...	saliva samples blood samples	18 Years -	Gustave Roussy, Cancer Campus, Grand Paris
Risk Stratification Among Individuals Who Have Many Moles on Their Skin	NCT03080948	High-Risk Nevus...	survey Saliva samples	18 Years -	Memorial Sloan Kettering Cancer Center
Iatrogenic Effects of Treatment for Childhood Cancer Constitution of a Biological Samples Bank	NCT02666625	Paediatric Mali...	saliva samples blood samples	18 Years -	Gustave Roussy, Cancer Campus, Grand Paris
Association Between Side Effects Occurrence and Concentrations of Ibrutinib and Idelalisib	NCT02824159	Hematological M...	Blood samples f... Imagery Quality of life... Detection of ad... Saliva samples Blood sample Biological stat... Clinical examin...	18 Years -	University Hospital, Toulouse
Biobank for African American Prostate Cancer Research in Florida	NCT03232411	Prostate Cancer	Questionnaires Saliva Samples Tumor Tissue	20 Years -	H. Lee Moffitt Cancer Center and Research Institute

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