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

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.

Study Overview

• Status: Unknown
• Conditions: Thyroid Cancer
• Intervention / Treatment: 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

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 Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: Hanan Omar Mohamed, Professor; Phone Number: 01223971654; Email: hannahomer@yahoo.com
• Study Contact Backup: Name: Amal Mohmmed Abdel Aal, Assistant professor; Phone Number: 01225433428; Email: amalabdelaal95@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Group(1) patient with thyroid cancer (30) Group(2) patient with begnin thyroid nodule (30) Group(3) normal healthy subjects as control (30)

Description

Inclusion Criteria:

• patient with thyroid mass

Exclusion Criteria:

• no other known organ malignancy no previous chemotherapy

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 (30); 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	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
Group 2 (30); 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	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
Group 3 (30); 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
level of serum midkine in thyroid cancer	Enzyme linked immunosorbent assay for estimation of serum midkine level	3 days

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start (Anticipated): March 29, 2018
• Primary Completion (Anticipated): December 29, 2019
• Study Completion (Anticipated): March 29, 2020

Study Registration Dates

• First Submitted: March 10, 2018
• First Submitted That Met QC Criteria: March 16, 2018
• First Posted (Actual): March 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 19, 2018
• Last Update Submitted That Met QC Criteria: March 16, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Hormones, Hormone Substitutes, and Hormone Antagonists; Antibodies; Hormones
• Other Study ID Numbers: LNCRHAMBTC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No