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Spinal Muscular AtrophyNCT00154960

Establishing Novel Detection Techniques for Various Genetic-Related Diseases by Applying DHPLC Platform.

An observational study of Spinal Muscular Atrophy and Neonatal Hyperbilirubinemia, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In this, here we want to present a new method for analysis variation in gene copy number for patients and carriers of SMA. This is a relative quantitation method and, therefore, relies on the inclusion of one or more internal control or reference sequences; quantitation of DNA is relative to this reference sequence of… Read more about this study

Who is it for?
Ages 0 years and olderHealthy volunteers can take part
How many people
1,000 participants
Where
1 siteTaiwan
Study dates
Jun 2004to not given
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Clinical diagnosis of Spinal muscular atrophy (SMA)

Who cannot join

  • nil

Trial locations and contacts

1 site in 1 country.

yi-ning su, MD,PhD contact

886-2-23123456 ext. 7675

ynsu@ntumc.org

Taiwan1 site, 1 recruiting
  • Dept of Medical Genetics;National Taiwan University Hospital

    Taipei, 100

    Yi-Ning Su, MD,PhD, 886-2-23123456 ext. 7675, ynsu@ntumc.org

    Recruiting

Other trials in Taiwan

About this study

In this, here we want to present a new method for analysis variation in gene copy number for patients and carriers of SMA. This is a relative quantitation method and, therefore, relies on the inclusion of one or more internal control or reference sequences; quantitation of DNA is relative to this reference sequence of known copy number. A peak height from within a potentially duplicated or deleted target region is amplified simultaneously with a disomic reference region in a multiplex PCR system.

Read the detailed description

Proximal spinal muscular atrophy is an autosomal recessive disorder with an overall incidence of 1 in 10000 live births and a carrier frequency of 1 in 50. This severe neuromuscular disease is characterized by a degeneration and loss of alpha motor neurons of the spinal cord anterior horn cells, which results in progressive symmetrical weakness, atrophy of the proximal voluntary muscles, and infant death. Here, we present a new, rapid, simple and high reliable method to detect the SMN1 deletion and to determine the copy number of the SMN1 and SMN2 by denaturing high-performance liquid chromatography (DHPLC). We demonstrate that this assay is able to accurately distinguish 2 gene copies from 4 gene copies and it can identify SMA carriers and normal populations by the accurate determination of SMN copy number.

Fecal DNA testing is a promising tool for colorectal cancer screening. Researchers have shown that DNA to be a good marker since it is stable in the stool; it shed continuously; and, through the use of amplification tests, it can be detected in minute amounts. Many DNA mutations associated with the process of colon cancer carcinogenesis have been characterized. K-ras oncogene, adenomatous polyposis coli (APC), p53, and microsatellite markers are examples of genes targeted as DNA markers in stool testing because they are critical to the control of colorectal cell growth. Early clinical studies have shown that multitarget DNA testing has a 71% to 91% sensitivity for detection of cancer and a 55% to 82% sensitivity for detecting adenoma 1cm or larger. We design this study, by using the automated DHPLC analysis and the microsatellite markers set already at first, to stepwisely set-up a high throughput but sensitive and specific screen method for colorectal cancer screen.

Neonatal hyperbilirubinemia is a common problem and is of concern not only to pediatricians but also to the parents of neonates. Two key enzymes, UDP-glucuronosyl transferase 1A1 and heme oxygenase-1 (HO-1), that involve bilirubin metabolism are highly noticed. First, UGT1A1 is the key enzyme for bilirubin conjugation and mutations of UGT1A1 cause the unconjugated hyperbilirubinemias known as Crigler-Najjar syndrome and Gilbert's syndrome. The high allele-frequency of Gly71Arg and promoter polymorphism in UGT1A1 gene was found to be responsible for neonatal hyperbilirubinemia without obvious cause. Second, HO-1 is a rate-limiting enzyme in the heme metabolism and allows for the degradation of heme to biliverdin. Recently, Maruo et al. demonstrated that (16/17) breastfed Japanese infants with apparent prolonged jaundice had at least one mutation of the UGT1A1. These data suggested that that defects of UGT1A1 may be an underlying cause of the prolonged unconjugated hyperbilirubinemia associated with breast milk. However, to date the association between breastfed infants with severe hyperbilirubinemia and UGT1A1 gene mutation is still unclear. In this study, we will analyze the UGT1A1 and HO-1 genes of infants with unconjugated hyperbilirubinemia associated with breast milk to ascertain whether genetic factors are involved.

This project will contribute to apply DHPLC on establishing various novels, fast, and reliable applications for diagnosis of SMA and carrier detection of SMN1 and SMN2 genes, sensitive and specific screen method for colorectal cancer screen, and analyze the UGT1A1 and HO-1 genes of infants with unconjugated hyperbilirubinemia associated with breast milk.

Keywords
Spinal muscular atrophy (SMA), SMN1/SMN2 gene, denaturing high-performance liquid chromatography (DHPLC), multiplex PCR, gene dose, carrier test, screen, stool, microsatellite
Medical subject headings
Muscular Atrophy, Spinal, Hyperbilirubinemia, Neonatal, Colonic Neoplasms

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startJun 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
1,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00154960
Sponsor's protocol ID
9300005565
Status last verified
Jun 2004
First submitted
9 Sep 2005
Last updated
28 Nov 2005
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Spinal Muscular Atrophy and Neonatal Hyperbilirubinemia, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact yi-ning su, MD,PhD (886-2-23123456 ext. 7675, ynsu@ntumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2005.

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