Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Causes of Goiter in Children Attending Assiut University Children Hospital

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03202160
Recruitment Status : Unknown
Verified June 2017 by MAAta, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
MAAta, Assiut University

Brief Summary:
Thyroid disorders are one of the most common endocrine problems in children and adolescents. Diagnostic considerations can be approached from the perspective of the goiter.A goiter, or thyromegaly, is an enlargement of the thyroid gland.Persons with enlarged thyroids can have normal function of the gland (euthyroidism), thyroid deficiency (hypothyroidism), or overproduction of the hormones (hyperthyroidism).

Condition or disease
Goiter

Detailed Description:

Congenital goiter most commonly occurs in neonates born to mothers with known thyroid disease especially Graves' disease. Other causes of congenital goitrous hypothyroidism are thyroid dyshormonogenesis, endemic iodine deficiency and maternal goitrogen ingestion or iodine excess (expectorants, povidone iodine).

The most common causes of euthyroid goiter in childhood are chronic lymphocytic thyroiditis and a colloid goiter (simple goiter). Thyroid enlargement that is not caused by inflammatory, infectious or neoplastic causes is termed a colloid goiter, also.

Chronic lymphocytic thyroiditis , also known as Hashimoto thyroiditis, is an autoimmune, inflammatory process that causes up to 55% to 65% of all euthyroid goiters, and almost all cases of thyroiditis in childhood and adolescence. A large North American prevalence study showed that as many as 1.2% of children aged 11 to18 years have chronic lymphocytic thyroiditis, as defined by an enlarged thyroid gland and detectable serum thyroid antibodies.

Thyroid nodules are relatively common in adolescents; these nodules are usually asymptomatic and often discovered incidentally, but they raise the fear of cancer. A multi-nodular goiter is almost invariably caused by Hashimoto's thyroiditis and it carries a good prognosis. The asymptomatic, solitary thyroid nodule is a thyroid adenoma, thyroid carcinoma or a thyroid cyst. Thyroid carcinoma occurs in approximately one per one million persons/year in the first-two decades of life.

No reported data are found as regard of causes of goiter in children in our locality.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Cases of Goiter in Children Attending Assiut University Children Hospital
Estimated Study Start Date : April 15, 2018
Estimated Primary Completion Date : April 15, 2019
Estimated Study Completion Date : September 15, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Serum T3 and T4 [ Time Frame: 1 day ]
    Serum T3 and T4 for diagnosis of cause of goiter

  2. Neck ultrasonography [ Time Frame: 1 day ]
    Neck ultrasonography for confirmation of diagnosis of goiter and for diagnosis of cause of goiter



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All cases of goiter attending Assiut University hospitals of ages since birth up to 18 years old in the period of study
Criteria

Inclusion Criteria:

  • Children of both sexes of ages since birth up to 18 years old who are presented by goiter.

Exclusion Criteria:

  • Any patient with neck swelling other than goiter.
  • Refusal of participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202160


Contacts
Layout table for location contacts
Contact: Hanaa A Mohammed, MD 00201120096055 ext Assiut hae50@hotmail.com
Contact: Eman A Abdel-Raoof, MD 00201099696173 ext Assiut emanaskar@hotmail.com

Sponsors and Collaborators
Assiut University
Investigators
Layout table for investigator information
Study Chair: Hanaa A Mohammed, MD Assiut University

Publications:
Layout table for additonal information
Responsible Party: MAAta, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03202160     History of Changes
Other Study ID Numbers: CGCA
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MAAta, Assiut University:
Goiter
Additional relevant MeSH terms:
Layout table for MeSH terms
Goiter
Thyroid Diseases
Endocrine System Diseases