P53 in Differentiated Thyroid Cancer

Thyroid Neoplasms Clinical Trial

Official title:

P53 Antibody; Is it an Indicator of Dedifferentiated Thyroid Cancer?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01954134
• Other study ID #: T-485
• Secondary ID: T-485
• Status: Completed
• Phase: N/A
• First received: September 11, 2013
• Last updated: September 26, 2013
• Start date: December 2010
• Est. completion date: January 2013

Study information

• Verified date: September 2013
• Source: Cumhuriyet University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Description:

In the present study enrolled were 171 patients with mean age of 47.7±13.5 yrs (range; 16-80yrs) and 28 healthy subjects with an age range of 18-52 yrs (mean: 36.0±9.8 yrs). 134 (78.4%) patients were female and 37 (21.6%) patients were male.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Dose 131-I given in another hospital

• Radioiodine treatment more than one year after thyroidectomy.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Neoplasms

Locations

Country	Name	City	State
Turkey	Cumhuriyet University, School of Medicine, Dept. of Nuclear Medicine	Sivas

Sponsors (1)

Lead Sponsor	Collaborator
Cumhuriyet University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Müller 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	There was not any risk for patients.		with in the first 8-10 months after surgery	Yes