P53 in Differentiated Thyroid Cancer | NCT01954134

Studies
P53 in Differentiated Thyroid Cancer

NCT01954134

Sponsor

Cumhuriyet University

Status

Completed

Last Update Posted

Oct 1, 2013Estimated

Enrollment

199Actual

Phase

Not provided

Conditions

Thyroid Neoplasms

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
T-485	Other Identifier	Cumhuriyet University Scientific Research Project Unit

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Sep 11, 2013

First Submission Date that Met QC Criteria

Sep 26, 2013

First Posted Date

Oct 1, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2013

Last Update Posted Date

Oct 1, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zekiye HASBEK, M.D., Assistant Professor, Cumhuriyet University, School of Medicine, Department of Nuclear Medicine, Cumhuriyet UniversityPrincipal Investigator

Lead Sponsor

Cumhuriyet UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

199Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
thyroid cancer, healty		Thyroid cancer group: patients with differentiated or dedifferentiated thyroid cancer Healty: control group

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
There was not any risk for patients.		with in the first 8-10 months after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zekiye Hasbek, M.D.	Cumhuriyet University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cumhuriyet University, School of Medicine, Dept. of Nuclear Medicine		Sivas		58140	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19693693	Result	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.
16964393	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.

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D006258	Head and Neck Neoplasms