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.
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
- Conditions the study is for
- Spinal Muscular Atrophy, Neonatal Hyperbilirubinemia, Colon Cancer
- 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.
Taiwan1 site, 1 recruiting
- Recruiting
Dept of Medical Genetics;National Taiwan University Hospital
Taipei, 100
Yi-Ning Su, MD,PhD, 886-2-23123456 ext. 7675, ynsu@ntumc.org
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.
- First posted12 Sep 2005 (estimated)
- Study startJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Muscular AtrophyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yi-Ning Su, MD,PhD, Study chair, National Taiwan University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Novel Detection Techniques for Various Genetic-Related Diseases by Applying DHPLC Platform.
- ClinicalTrials.gov ID
- NCT00154960
- Acronym / sponsor ID
- 9300005565
- Keywords
- Spinal muscular atrophy (SMA), SMN1/SMN2 gene, denaturing high-performance liquid chromatography (DHPLC), multiplex PCR, gene dose, carrier test, screen, stool
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2004
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Spinal muscular atrophy (SMA)
Key exclusion criteria (1 listed)
- nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2005.
Related trials for Spinal Muscular Atrophy
Active, not recruitingPhase 4
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
Muscular Atrophy, Spinal
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingObservational study
A Study of Risdiplam in Participants With Type I and Type II Spinal Muscle Atrophy (SMA)
Spinal Muscle Atrophy
RecruitingPhase 3
A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)
Metastatic Castration Resistant Prostate Cancer
Recruiting
Assessment of a Portable Digital Device for Quantified Analysis of Markerless Walking in Volunteers With Neuromuscular Diseases or Asymptomatic Volunteers
Spinal Muscular Atrophy (SMA), Charcot-Marie-Tooth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Ning Su, MD,PhD study chair
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
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.