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Chromosome Aberrations clinical trials

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NCT ID: NCT02278874 Completed - Trisomy 21 Clinical Trials

High Risk Multiple Gestation Study

Start date: August 2014
Phase:
Study type: Observational

The objectives of the clinical study are to demonstrate the accuracy of our proprietary algorithm method to determine the genetic health of the developing fetuses in a multiple gestation pregnancy from a maternal blood sample. The long term goal of this study will be the development of a method of minimally invasive prenatal diagnosis that has a higher sensitivity and lower false positive rate in the intended population (e.g. multiple gestation pregnancies) than other currently available screening tests. This will result in fewer unnecessary amniocenteses and Chorionic Villus Sample (CVS) procedures, which are associated with a risk of miscarriage.

NCT ID: NCT02278536 Completed - Trisomy 21 Clinical Trials

Multiple Gestation Study

Start date: March 2013
Phase:
Study type: Observational

The objectives of the clinical study are to demonstrate the accuracy of our new NATUS diagnostic method to determine the genetic health of the developing fetuses in a multiple gestation pregnancy from a maternal blood sample. The long term goal of this study will be the development of a method of minimally invasive prenatal diagnosis that has a higher sensitivity and lower false positive rate in the intended population (e.g. multiple gestation pregnancies) than any currently available screening tests. This will result in fewer unnecessary amniocenteses and CVS procedures, which are associated with a risk of miscarriage.

NCT ID: NCT02109770 Completed - Trisomy 21 Clinical Trials

Development of Non-invasive Prenatal Test for Microdeletion and Other Genetic Syndromes Based on Cell Free DNA

Microdel Triad
Start date: October 2012
Phase:
Study type: Observational

The purpose of this study is to collect blood from families with a child who has been diagnosed with a chromosomal disorder including microdeletions in order to further develop a non-invasive prenatal screening test based on fetal DNA isolated from maternal blood.

NCT ID: NCT01884610 Completed - Clinical trials for Chromosome Aberrations

Study on the Impact of Stem Cell Donation and Bone Marrow Harvesting on Unrelated Donors

Start date: September 2008
Phase: N/A
Study type: Observational

Granulocyte Colony Stimulating Factor (GCSF) is used extensively as a means of mobilising donor peripheral blood stem cells as an alternative to bone marrow harvesting for the purpose of recipient stem cell transplantation. The principal objective of the research is to study any longterm genetic effects of GCSF in the peripheral blood white cells of unrelated blood stem cell donors. The study subjects will be Retrospective and Prospective voluntary unrelated donors on the Anthony Nolan Bone Marrow Registry being harvested at the Royal Free Hospital and University College Hospital, London and British Bone Marrow Registry donors harvested at the Royal Free Hospital and BUPA Glen Vale in Bristol. All participants in the Prospective Arm will be asked to donate one 5−10ml sample of blood at study entry prior to stem cell donation and further samples at 120 and 360 days post donation. Those found to carry aneuploid cell clones at these time points will be asked for a further 5−10ml blood sample at least twice − at the end of 24 months and 36 months respectively. The Retrospective and Positive Control group will be asked to supply one 5−10ml sample of blood.

NCT ID: NCT01852708 Completed - Trisomy 21 Clinical Trials

Development of Non-invasive Prenatal Screening Test for Microdeletions Based on Fetal DNA Isolated From Maternal Blood

MAPS
Start date: November 2012
Phase:
Study type: Observational

The purpose of this study is to collect maternal blood samples from pregnant women carrying a fetus with a confirmed diagnosis of chromosomal abnormality or genetic disorder including microdeletions in order to further develop a non-invasive prenatal screening test based on fetal DNA isolated from maternal blood.

NCT ID: NCT01620853 Completed - Clinical trials for Non-small Cell Lung Cancer (NSCLC)

Detection of Chromosomal Aberrations in Non-small Cell Lung Cancer (NSCLC) Using Fluorescent in Situ Hybridization (FISH) (ALK Test)

Start date: May 2012
Phase: N/A
Study type: Observational

The purpose of the study is the identification of chromosomal aberrations in non-small cell lung cancer (NSCLC) . The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying ALK FISH stained lung samples.

NCT ID: NCT01574781 Completed - Clinical trials for Sex Chromosome Aberrations

Non-invasive Prenatal Diagnostic Validation Study

NIPD
Start date: September 2011
Phase: N/A
Study type: Observational

The primary purpose of this study is to collect maternal blood samples from pregnant women to develop a non-invasive prenatal diagnostic test based on fetal DNA isolated from maternal blood.

NCT ID: NCT01463410 Terminated - Clinical trials for Acute Myeloid Leukemia (AML)

Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler

Start date: October 2011
Phase: N/A
Study type: Observational

This clinical study will demonstrate the accuracy of the chromosomal aberration and gene mutation markers of the AMLProfiler molecular diagnostic assay and generate clinical performance data to support a Pre-Market Approval (PMA) submission to the Food and Drug Administration for in vitro diagnostic use within the United States of America. The objective is to demonstrate the positive and negative percent agreement of each marker by comparing AMLProfiler results from multiple clinical participating sites with data generated using a laboratory developed bi-directional sequencing method generated at the molecular diagnostic reference lab. The AMLProfiler assay is a qualitative in vitro diagnostic test for the detection of AML or APL specific chromosomal aberrations (specific recurrent translocations and inversions), as well as expression of specific genetic markers in RNA extracted from bone marrow aspirates of patients with Acute Myeloid Leukemia.

NCT ID: NCT01426308 Completed - Clinical trials for Post-natal Cytogenetics

Method Comparison and Clinical Specificity Study: Evaluation of the Infinium HD Cytogenetic Abnormality Test

Start date: August 2011
Phase: N/A
Study type: Observational

The study will determine the performance of the Infinium HD Test. - The primary objective of the study is to assess the performance of the Infinium HD Test using banked DNA samples extracted from whole blood patient samples derived from the intended use population. - The secondary objective of the study is to determine the background number of chromosomal abnormalities per person in the general population based on the resolution of the Infinium HD Test.

NCT ID: NCT01264744 Completed - Bladder Cancers Clinical Trials

Detection of Chromosomal Aberrations in Urine Samples Using Fluorescent in Situ Hybridization (FISH) (UroVysion Test)

Start date: November 2009
Phase: N/A
Study type: Observational

The purpose of the study is the identification of chromosomal aberrations in urine samples. The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classification of UroVysion FISH stained Urine samples.