Symptoms and General Pathology

All Conditions

Blood and Lymph Conditions

Neoplasms

Behaviors and Mental Disorders

Rare Diseases

Syndrome

Anemia

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Hematologic Diseases

Precancerous Conditions

Quality of Life

Hematinics

All Drugs and Chemicals

Epoetin Alfa

epidemiologic study

Janssen-Cilag S.p.A. Clinical Trial

The purpose of this study is to evaluate the correlation between quality of life (QoL) and hemoglobin in patients affected by myelodysplastic syndrome and to compare the MDS (MyeloDisplastic Syndrome) patient's self-assessed QoL according to physician's evaluation

In low-risk Myelodysplastic Syndrome (MDS), anemia is the major clinical problem and often represents the principal cause of symptoms which negatively influence quality of life (QoL). Moreover anemia has been associated with increased cardiac disease which, in older patients, may aggravate pre-existing conditions such as congestive heart failure. Patients with MDS often require red blood cell transfusions that further deteriorate patients' perception of well-being. This is an 18-month prospective observational investigation about the Quality of Life in Myelodysplastic patients with the aim to evaluate the correlation between hemoglobin (Hb) value and QoL and to compare the MDS patient's self-assessed QoL per physician's assessment. One hundred and fifty consecutive MDS patients at diagnosis and at least one with cytopenia - low level of hemoglobin or low level of neutrophils (a type of white blood cells that fights against infection) or low level of platelets (irregularly shaped cells found in blood that help prevent bleeding) - will be included in the evaluation. Demographic and disease-specific data will be collected and QoL will be evaluated by a specific questionnaire named QoL-E which will be completed both by patients and respective physicians. Study visits will be performed monthly until week 12; the subsequent visits will be performed at 6, 12 and 18 months. No Serious Adverse Event will be collected during the study, only adverse reaction to any Janssen-Cilag drug should be reported. This information may be important to optimize treatment according to patients' preferences and expectations, to detect functional complications, as well as to improve communication between patients and caregivers. Observational study - No study drug was administered.

Survey on QUality of Life In myeloDisplasia (SQUID)

QUALITY OF LIFE ASSESSMENT IN PATIENTS AFFECTED BY MYELODYSPLASTIC SYNDROME

Janssen-Cilag S.p.A.

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Small Cell Lung Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Small Cell Lung Cancer

DNA methylation analysis

DNA stability analysis

gene expression analysis

study of socioeconomic and demographic variables

biopsy

evaluation of cancer risk factors

study of high risk factors

John K. Field, MA, BDS, PhD, FRCPath

Contact Person

Peter Clark, MD

Ernest Marshall, MD

RATIONALE: Environmental exposure and genetic predisposition may affect the risk of developing cancer later in life. Learning about genetic markers and the long-term effects of environmental exposure may help the study of lung cancer in the future.

PURPOSE: This research study is looking at risk factors and genetic markers in healthy participants and in patients with lung cancer.

OBJECTIVES:

* To prepare a molecular genetic and epidemiological risk assessment model based on the analysis of environmental exposures and genetic predisposition, which will provide an algorithm to measure an individual's risk for developing lung cancer.
* To develop an archive of specimens relating to at-risk individuals and those with lung cancer.
* To redefine lung cancer based on molecular pathology using the fields of expression and methylation profiling, and genetic instability.
* To identify and assess novel markers of pre-carcinogenesis in our high-risk populations.
* To facilitate the development of new intervention strategies (i.e., chemoprevention).

OUTLINE: This is a multicenter study.

Participants and/or patients undergo tumor tissue, sputum, and blood sample collection periodically. Samples are analyzed via fields of expression and methylation profiling and genetic instability. Samples are also archived.

Complete lifetime lifestyle, residential, environmental tobacco smoke, and occupational history are assessed in the first year and then in year five and year ten. Participants who return for follow-up complete a shorter questionnaire aimed at recording change over the interval since their last attendance.

PROJECTED ACCRUAL: 800 patients and 7,500 healthy participants will be accrued for this study.

Liverpool Lung Project: Risk Factors and Genetic Markers in Healthy Participants and Patients With Lung Cancer

Liverpool Lung Project

University of Liverpool Cancer Research Centre

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Survey on QUality of Life In myeloDisplasia (SQUID)	NCT00967564	Myelodysplastic...	epidemiologic s...	18 Years -	Janssen-Cilag S.p.A.
Liverpool Lung Project: Risk Factors and Genetic Markers in Healthy Participants and Patients With Lung Cancer	NCT00503958	Health Status U... Lung Cancer	DNA methylation... DNA stability a... gene expression... epidemiologic s... study of socioe... biopsy evaluation of c... study of high r...	45 Years - 79 Years	National Cancer Institute (NCI)
Liverpool Lung Project: Risk Factors and Genetic Markers in Healthy Participants and Patients With Lung Cancer	NCT00503958	Health Status U... Lung Cancer	DNA methylation... DNA stability a... gene expression... epidemiologic s... study of socioe... biopsy evaluation of c... study of high r...	45 Years - 79 Years	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for epidemiologic study