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

NCT ID: NCT03469544

Last Updated: 2018-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-29
• Study Completion Date: 2020-03-29

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.

Conditions

Thyroid Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

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

Intervention Type: OTHER

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

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

Intervention Type: OTHER

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

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

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patient with thyroid mass

Exclusion Criteria

• no other known organ malignancy no previous chemotherapy

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hala Saleh Abdelghafour

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hanan Omar Mohamed, Professor

Role: CONTACT

hannahomer@yahoo.com

01223971654

Amal Mohmmed Abdel Aal, Assistant professor

Role: CONTACT

amalabdelaal95@gmail.com

01225433428

References

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

Reference Type: BACKGROUND

Other Identifiers

LNCRHAMBTC

Identifier Type: -

Identifier Source: org_study_id