Long Non Coding RNA HOTAIR and Midkine as Biomarkers in Thyroid Cancer

• Conditions: Thyroid Cancer
• Interventions: 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

• Registration Number: NCT03469544
• Lead Sponsor: Assiut University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2018-03
• Study First Submitted: 2018-03-10
• Study First Submitted QC: 2018-03-16
• Last Update Submitted: 2018-03-16
• Study First Posted: 2018-03-19
• Last Update Posted: 2018-03-19
• Study Start: 2018-03-29
• Primary Completion: 2019-12-29
• Study Completion: 2020-03-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• patient with thyroid mass

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Exclusion Criteria

• no other known organ malignancy no previous chemotherapy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1 (30)	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	Patient with cancer thyroid proved by cytological analysis Interventions;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
Group 2 (30)	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	Patient with benign thyroid nodule Interventions;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
Group 3 (30)	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	Normal healthy subjects as control group Interventions;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

Primary Outcome Measures

Name	Time	Method
Expression of long non coding RNA HOTAIR	3 days	Quantitation of long non coding RNA HOTAIR by real time polymerase chain reaction in peripheral blood

Secondary Outcome Measures

Name	Time	Method
level of serum midkine in thyroid cancer	3 days	Enzyme linked immunosorbent assay for estimation of serum midkine level