Vocal Cord ParalysisNCT00382369
Whole Genome Scan of Extended Families With Familial Vocal Cord Paralysis
An observational study of Vocal Cord Paralysis, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Vocal cord paralysis is a common cause of congenital stridor and airway obstruction. In this study we plan to identify the genetic locus of the genes in two extended families who suffer of the disease. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Vocal Cord Paralysis
- How many people
- 11 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 2008to 29 Dec 2008
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Families suffering of familial vocal cord paralysis
Who may be able to join
- members of families suffering of familial vocal cord paralysis
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah-Hebrew University Medical Center, Mt Scopus
Jerusalem, 24035
About this study
Vocal cord paralysis is a common cause of congenital stridor and airway obstruction. In this study we plan to identify the genetic locus of the genes in two extended families who suffer of the disease.
Read the detailed description
In a number of families suffering of familial vocal cord paralysis it has previously been shown that the disease is inherited autosomal dominant. In one of the families the gene coding for the disease was located on chromosome 6q16. We will be analyzing 2 extended families with familial vocal cord paralysis to define their genetic defect leading to the disease. All family members will undergo a laryngoscopy to determine the extent of paralysis. For all family members we will isolate DNA and determine their microsatellite polymorphism on chromosome 6q16. If the results are negative we will continue the study and perform a whole genome scan to localize the gene(s) involved.
- Conditions
- Vocal Cord Paralysis
- Keywords
- familial vocal cord paralysis, genetic screening
- Medical subject headings
- Vocal Cord Paralysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2006 (estimated)
- Study start1 Jun 2008
- Primary completion17 Nov 2008
- Study completion29 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vocal Cord ParalysisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerem Eithan, Hadassah Medical Organization
- Investigators
- Eitan Kerem, MD, Study director, Hadassah MOBatsheva Kerem, PhD, Principal investigator, Hebrew University Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382369
- Sponsor's protocol ID
- VOCALCORD-HMO-CTIL
- Status last verified
- Feb 2017
- First submitted
- 28 Sep 2006
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Manaligod JM, Skaggs J, Smith RJ. Localization of the gene for familial laryngeal abductor paralysis to chromosome 6q16. Arch Otolaryngol Head Neck Surg. 2001 Aug;127(8):913-7. doi: 10.1001/archotol.127.8.913.
PubMed 11493198
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Genome Scan of Extended Families With Familial Vocal Cord Paralysis
- ClinicalTrials.gov ID
- NCT00382369
- Acronym / sponsor ID
- VOCALCORD-HMO-CTIL
- Conditions
- Vocal Cord Paralysis
- Keywords
- familial vocal cord paralysis, genetic screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 1 Jun 2008 (actual)
- Primary completion
- 17 Nov 2008 (actual)
- Study completion
- 29 Dec 2008 (actual)
- First posted
- 29 Sep 2006 (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.
Vocal cord paralysis is a common cause of congenital stridor and airway obstruction. In this study we plan to identify the genetic locus of the genes in two extended families who suffer of the disease.
Detailed description
In a number of families suffering of familial vocal cord paralysis it has previously been shown that the disease is inherited autosomal dominant. In one of the families the gene coding for the disease was located on chromosome 6q16. We will be analyzing 2 extended families with familial vocal cord paralysis to define their genetic defect leading to the disease. All family members will undergo a laryngoscopy to determine the extent of paralysis. For all family members we will isolate DNA and determine their microsatellite polymorphism on chromosome 6q16. If the results are negative we will continue the study and perform a whole genome scan to localize the gene(s) involved.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Families suffering of familial vocal cord paralysis
Key inclusion criteria (1 listed)
- members of families suffering of familial vocal cord paralysis
Key exclusion criteria (1 listed)
- none
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Background: PubMed 11493198Manaligod JM, Skaggs J, Smith RJ. Localization of the gene for familial laryngeal abductor paralysis to chromosome 6q16. Arch Otolaryngol Head Neck Surg. 2001 Aug;127(8):913-7. doi: 10.1001/archotol.127.8.913.
- Individual participant dataSharing planned: No
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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.
Eitan Kerem, MD study director
Hadassah MO
Batsheva Kerem, PhD principal investigator
Hebrew University Jerusalem
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 Vocal Cord Paralysis, run by Hadassah Medical Organization at 1 site in Israel.
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: finished, as of the sponsor's last update on 27 Feb 2017. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00382369, which also lists 1 linked publication.
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 27 Feb 2017.