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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03469544
Other study ID # LNCRHAMBTC
Secondary ID
Status Not yet recruiting
Phase
First received March 10, 2018
Last updated March 16, 2018
Start date March 29, 2018
Est. completion date March 29, 2020

Study information

Verified date March 2018
Source Assiut University
Contact Hanan Omar Mohamed, Professor
Phone 01223971654
Email hannahomer@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Thyroid cancer is the most prevalent endocrine malignancy.Papillary thyroid carcinomas and follicular thyroid carcinomas account for 95% of all thyroid cancer cases. They are clinically classified as well-differentiated thyroid carcinomas due to their biological behavior resembling normal follicular cells and good responsiveness to surgery and radioiodine therapy . However, they are usually curable when discovered at early stages, but survival rates may be reduced from 100% in stages I and II to 50% at stage IV So,early detection is the key for successful treatment and reduction of mortality.

pathological analysis by fine-needle aspiration biopsies has some limitations including difficulty in sampling small tumors, inconclusive diagnosis in up to 35% of patients and bleeding. Thus, biomarkers for diagnosis are needed.


Description:

Thyroid cancer is the most prevalent endocrine malignancy.Papillary thyroid carcinomas and follicular thyroid carcinomas account for 95% of all thyroid cancer cases. They are clinically classified as well-differentiated thyroid carcinomas due to their biological behavior resembling normal follicular cells and good responsiveness to surgery and radioiodine therapy . However, they are usually curable when discovered at early stages, but survival rates may be reduced from 100% in stages I and II to 50% at stage IV So,early detection is the key for successful treatment and reduction of mortality.

pathological analysis by fine-needle aspiration biopsies has some limitations including difficulty in sampling small tumors, inconclusive diagnosis in up to 35% of patients and bleeding. Thus, biomarkers for diagnosis are needed.

The concept of liquid biopsy was proposed in contrast to the traditional tissue biopsy which is particularly important for solid tumor diagnosis. It refers to the process of detecting genetic materials, using non-invasive method from blood or other body fluids.Long noncoding RNAs (LncRNAs) have recently been demonstrated to participate in cancer progression.HOTAIR is the type of non coding RNA that will be investigated for its ability to differentiate benign from malignant thyroid nodule Midkine a basic heparin-binding growth factor of low molecular weight, capable of exerting activities such as cell proliferation, cell migration, angiogenesis and fibrinolysis. Midkine expression is closely related with progression of tumor stage. If tumor tissues increase secretion of midkine, it becomes evident in serum.The expression of midkine gene in human tumor cells may reflect tumor formation and give clues to the biological behavior of neoplasms. Hence, the expression of midkine may serve as a tumor marker for diagnosis and follow-up.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date March 29, 2020
Est. primary completion date December 29, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- patient with thyroid mass

Exclusion Criteria:

- no other known organ malignancy no previous chemotherapy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
complete blood picture ,serum urea and creatinine,liver function test,T3,T4,thyroid stimulating hormone,thyroglobuline and thyroglobuline anti body specific test Real time polymerase chain reaction
complete blood picture ,serum urea and creatinine,liver function test,T3,T4,thyroid stimulating hormone,thyroglobuline and thyroglobuline anti body . specific test is quantitation of long non coding RNA HOTAIR by Real time polymerase chain reaction in peripheral blood,Enzyme linked Immunosorbent Assay for serum midkine level

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (1)

Aizizi Abudoureyimu*, Reyihanguli Maimaiti*, Sailike Magaoweiya, Duman Bagedati, Hao WenIdentification of long non-coding RNA expression profile in tissue and serum of papillary thyroid carcinoma Department of Vascular Thyroid Surgery, Gastrointestinal Vascular Center, The First Affiliated Hospital of Xinjiang Medical University, Urumqi 830054, Xinjiang, China.Int J Clin Exp Pathol 2016;9(2):1177-1185 .ISSN:1936-2625/IJCEP0013372

Outcome

Type Measure Description Time frame Safety issue
Primary Expression of long non coding RNA HOTAIR Quantitation of long non coding RNA HOTAIR by real time polymerase chain reaction in peripheral blood 3 days
Secondary level of serum midkine in thyroid cancer Enzyme linked immunosorbent assay for estimation of serum midkine level 3 days
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