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

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ClinicalTrials.gov Identifier: NCT02309567
Recruitment Status : Completed
First Posted : December 5, 2014
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Zekiye HASBEK, M.D., Assistant Professor, Cumhuriyet University

Brief Summary:
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.

Condition or disease Intervention/treatment
Lung Neoplasms Gene, p53 Other: Blood Collection

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Study Type : Observational
Actual Enrollment : 146 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : May 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer




Primary Outcome Measures :
  1. 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. ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Lung cancer patients and patients who have suspected pulmonary lesion
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02309567


Locations
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Turkey
Cumhuriyet University, School of Medicine, department of Nuclear Medicine
Sivas, Campus, Turkey, 58140
Sponsors and Collaborators
Cumhuriyet University

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Responsible Party: Zekiye HASBEK, M.D., Assistant Professor, Cumhuriyet University, School of Medicine, Department of Nuclear Medicine, Cumhuriyet University
ClinicalTrials.gov Identifier: NCT02309567    
Other Study ID Numbers: T-597
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Keywords provided by Zekiye HASBEK, M.D., Assistant Professor, Cumhuriyet University:
Anti-p53 antibody
PET/CT
Lung Cancer
FDG
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs