P53 in Differentiated Thyroid Cancer

NCT01954134 | Completed DMC

• 1 other identifier: T-485
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

In clinical practise patients with negative radioiodine scan with positive tyhroglobulin is considered as radioiodine resistant or in another words in the process of dedifferentiation. The aim of the present study was to search a simple blood test that could lead to early identification of patients with dedifferentiation. In this respect, we investigate whether the serum level of anti-p53 antibody has the diagnostic value in the follow-up of patients with high levels of thyroglobulin (tg) and negative I-131 scan.

Conditions

Thyroid Neoplasms

Keywords

Tumor Suppressor Protein p53,; Iodine Radioisotopes

Outcome Measures

Primary Outcomes (1)

• There was not any risk for patients.

  with in the first 8-10 months after surgery

Study Arms (1)

thyroid cancer, healty

Thyroid cancer group: patients with differentiated or dedifferentiated thyroid cancer Healty: control group

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 171 patients with an age range of 16-80 yrs (mean: 47.7±13.5 yrs) and a total of 28 healthy subjects with an age range of 18-52 yrs (mean: 36.0±9.8 yrs) were included in this study.

You may qualify if:

• Patients who were diagnosed with DTC
• Treated with total and/or near-total thyroidectomy
• Referred for I-131 ablation therapy or low dose I-131 whole body scan (WBS)
• Between December 2010 and January 2013.

You may not qualify if:

• Dose 131-I given in another hospital
• Radioiodine treatment more than one year after thyroidectomy.

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Cumhuriyet University, School of Medicine, Dept. of Nuclear Medicine

Sivas, 58140, Turkey (Türkiye)

Location

Related Publications (3)

• Wu M, Mao C, Chen Q, Cu XW, Zhang WS. Serum p53 protein and anti-p53 antibodies are associated with increased cancer risk: a case-control study of 569 patients and 879 healthy controls. Mol Biol Rep. 2010 Jan;37(1):339-43. doi: 10.1007/s11033-009-9744-7. Epub 2009 Aug 20.

  PMID: 19693693 RESULT

• Muller M, Meyer M, Schilling T, Ulsperger E, Lehnert T, Zentgraf H, Stremmel W, Volkmann M, Galle PR. Testing for anti-p53 antibodies increases the diagnostic sensitivity of conventional tumor markers. Int J Oncol. 2006 Oct;29(4):973-80.

  PMID: 16964393 RESULT

• Hasbek Z, Turgut B, Erselcan T. p53 antibody: is it an indicator of dedifferentiated thyroid cancer? Ann Nucl Med. 2014 Jan;28(1):42-6. doi: 10.1007/s12149-013-0783-8.

  PMID: 24234516 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Zekiye Hasbek, M.D.

  Cumhuriyet University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cumhuriyet University, School of Medicine, Department of Nuclear Medicine

Study Record Dates

• First Submitted: September 11, 2013
• First Posted: October 1, 2013
• Study Start: December 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: October 1, 2013

Record last verified: 2013-09

Locations

TU (1)