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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02256163
Other study ID # NI10023
Secondary ID N° ID RCB: 2010-
Status Completed
Phase N/A
First received October 1, 2014
Last updated November 17, 2017
Start date June 2011
Est. completion date March 2017

Study information

Verified date November 2017
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objectives of the study are

- to assess the contribution of alteration of each known gene on non-syndromic TAA.

- to map and identify unknown gene involved in the non-syndromic TAA.


Description:

The secondary objectives of the study are

- to study the correlation of phenotype-genotype, in particular, to compare the aortic phenotype of non-syndromic TAA patients and TAA syndromic patients.

- to develop national standardized strategies of genetic diagnosis and of clinical management using genetic data.


Recruitment information / eligibility

Status Completed
Enrollment 258
Est. completion date March 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

For all:

- Aged > 18 years.

- Written informed consent obtained.

- People with health insurance.

For individual:

- people = 45 years, thoracic aortic aneurysm without syndrome,

- or people > 45 years with familial TAA.

For family:

- At least 2 members of family in 2 generations have TAA without syndrome and at least 2 patients of TAA will undergo blood collection.

- All people in family will undergo blood collection, each member should declare at first his (her) status (with or without TAA, unknown), the relationship (direct relative family or family in-law), no limit of age. For the children, only those with TAA will perform blood collection for the study.

Exclusion Criteria:

- Thoracic aortic aneurysm with different syndromes (Marfan syndrome, Ehlers-Danlos syndrome, Loeys-Dietz syndrome, Turner syndrome, Noonan syndrome).

- Arterial hypertension.

Study Design


Locations

Country Name City State
France Département de Génétique, Hôpital Bichat Paris Ile De France

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Impact of known mutations and research of new genes involved in non syndromic TAA Research for mutations in known genes such as FBN1, TGFBR1, TGFBR2, ACTA2, or MYH11.
Research for new genes in families and in individuals TAA patients without known mutation.
1 year
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