Is There Any Relation Between Serum Anti-p53 Antibody and TLG, MTV and SUV as PET Parameters in Lung Cancer Patients?

October 30, 2016 updated by: Zekiye HASBEK, M.D., Assistant Professor, Cumhuriyet University
p53 is a tumor suppressor gene which plays an important role in controlling normal cell proliferation regulation that is located on the chromosome 17 (17p13.1). It is the most common goal of genetic alteration in many tumors. Serum p53 protein is presence in normal healthy individuals. However p53 antibody is extremely rare. Mutations in this gene cause an accumulation of non-functional proteins and development of anti-p53 antibodies, which can be detectable in tissues, slouhed cells, blood and other body fluids. Some studies have reported that, p53 mutations are highly common in leukemia, lymphoma, lung, esophagus, stomach, liver, bone, bladder, ovarian, and brain cancers. Lung cancer is the most common cause of cancer-related deaths and the survey is low after the initial diagnosis. Accurate staging is important for determine the choice of treatment and predict prognosis. 18F-FDG PET/BT has important value for initial staging and it is the most advanced imaging technique developed all over the world for determine of the characterization of the metabolic tumor volume. Maksimum Standardized Uptake Value (SUVmax) which was acquired by PET imaging is commonly used in clinical practice as a criterion for malignancy. Due to the development of new software programs recently studies have shown that metabolic tumor volume (MTV) and total lesion glycolysis (TLG) may be useful quantitative parameters for the prognostic evaluation. Viable tumor volume could be estimate with this programs.The purpose of this study was to assess the relation between serum anti-p53 antibody level and quantitative PET parameters as SUVmax, SUVave, MTV and TLG.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

146

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Campus
      • Sivas, Campus, Turkey, 58140
        • Cumhuriyet University, School of Medicine, department of Nuclear Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Lung cancer patients and patients who have suspected pulmonary lesion

Description

Inclusion Criteria:

  • patients who were referred to our department with the purpose of 18F-FDG PET/CT imaging for staging due to lung cancer diagnosis
  • patients who were performed 18F-FDG PET/CT for diagnosis in the cause of the suspected pulmonary nodule/lesion in thorax CT but not detected pathologic FDG accumulation
  • In the control group, healthy subjects with no history of cancer and without any complaint

Exclusion Criteria:

  • Patients had operated for lung cancer, received prior chemotherapy or radiotherapy for lung cancer, with no definitive histological diagnosis, and a blood glucose level greater than 150 mg/dL

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum anti-p53 antibody level measurement.
Time Frame: Blood samples for serum anti-p53 antibody will taken before the FDG administration. All serum will immediately frozen and stored. Analysis will performed presumably after 3 months.
Blood samples for serum anti-p53 antibody will taken before the FDG administration. All serum will immediately frozen and stored. Analysis will performed presumably after 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cumhuriyet University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

December 3, 2014

First Posted (ESTIMATE)

December 5, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 30, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T-597

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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