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P53 in Differentiated Thyroid Cancer

NCT ID: NCT01954134

Last Updated: 2013-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

199 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Thyroid Neoplasms

Keywords

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Tumor Suppressor Protein p53, Iodine Radioisotopes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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thyroid cancer, healty

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cumhuriyet University

OTHER

Sponsor Role lead

Responsible Party

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Zekiye HASBEK, M.D., Assistant Professor

Cumhuriyet University, School of Medicine, Department of Nuclear Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zekiye Hasbek, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cumhuriyet University

Locations

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

Sivas, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 19693693 (View on PubMed)

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.

Reference Type RESULT
PMID: 16964393 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24234516 (View on PubMed)

Other Identifiers

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T-485

Identifier Type: OTHER

Identifier Source: secondary_id

T-485

Identifier Type: -

Identifier Source: org_study_id