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NCT00410241 · ClinicalTrials.gov registry record

ClinSeq: A Large-Scale Medical Sequencing Clinical Research Pilot Study

A clinical trial of Healthy Volunteers and Atherosclerotic Heart Disease, sponsored by National Human Genome Research Institute (NHGRI).

Active
Registry status
1,665
Enrollment target
2
Study locations

NCT00410241 is a study of Healthy Volunteers and Atherosclerotic Heart Disease that is active but no longer recruiting, run by National Human Genome Research Institute (NHGRI). The registered enrollment target is 1,665 participants, above the 476-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (250% higher). The trial reports 2 study locations across 1 state.

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The verdict

NCT00410241, a study of Healthy Volunteers and Atherosclerotic Heart Disease, is active but no longer recruiting, sponsored by National Human Genome Research Institute (NHGRI).

ACTIVE NOT RECRUITING
Registry status
1,665 participants
Enrollment target
2
Study locations

Study Summary

This study will examine genome sequencing in clinical research. Genome sequencing is a process in which researchers analyze (or sequence) part or all of the genome from a single person. The human genome is the material in cells that includes thousands of genes. Gene changes that cause or contribute to disease can be passed on from one generation to the next. This study first focuses on heart disease. Later, researchers hope to study other conditions and genes, with the eventual goal of sequencing most or all of participants genes. Participants ages 45 to 65 years of age and who do not smoke, may be eligible for this study. Patients will come to the NIH Clinical Research Center for an initial study to last about half a day. They will donate a blood sample and complete a short survey. Then they will meet the genetic counselor to learn more about genome sequencing. Those who join the study will undergo the following procedures and evaluations: * Family history and medical history. * Measurement of height and blood pressure. * Noninvasive heart tests, including electrocardiogram and echocardiogram. * Drawing of about 3 ounces of blood (5 to 6 tablespoons); part of the blood sample will be used for research and another part for clinical testing. * Multidetector computed tomography (CT), a test to measure coronary artery calcification, that is, condition of inflexibility. Each patient will receive a letter with results of the clinical laboratory values and evaluations. There will be recommendations for follow-up with the patient s doctors. Risks in this study include exposure to radiation from the CT test. The radiation amount used is about the same that a person normally receives from natural sources, such as from the sun, outer space, and radioactive materials found naturally in the earth s air and soil. Another slight risk involves reactions to a contrast agent that may be used in the echocardiogram. Side effects can be headache, nausea or vomiting, a warm sensation

Study Locations (2)

Maryland

  • Suburban Hospital - Bethesda
  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 1,665 participants
Start Date 2007-01-05

What the Registry Record Tells You About NCT00410241

The ClinicalTrials.gov registry entry for NCT00410241 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 1,665 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 476-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (250% higher). The listed sponsor is National Human Genome Research Institute (NHGRI), which has 185 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 0 interventions.

NCT00410241 reports 2 study locations spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00410241 about?

NCT00410241 is a clinical study titled "ClinSeq: A Large-Scale Medical Sequencing Clinical Research Pilot Study". This study will examine genome sequencing in clinical research. Genome sequencing is a process in which researchers analyze (or sequence) part or all of the genome from a single person. The human genome is the material in cells that includes thousands of genes. Gene changes that cause or contribute ...

What is the current status of trial NCT00410241?

This trial is currently active not recruiting. The enrollment target is 1,665 participants. The study started on 2007-01-05.

What conditions does trial NCT00410241 study?

This clinical trial studies the following conditions: Healthy Volunteers, Atherosclerotic Heart Disease.

Who is sponsoring clinical trial NCT00410241?

This trial is sponsored by National Human Genome Research Institute (NHGRI), which has 185 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00410241 being conducted?

This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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