Oxidoreductive Balance and Lysosomal Activity in Cancer Patients.

NCT03470857 | Completed DMC

• 1 other identifier: KB 363/2017
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 3

Brief Summary

The research aims to determine the parameters of oxidative stress and inflammatory processes and compare these parameters with the image obtained using positron emission tomography (PET) with 2-deoxy-2-\[fluorine-18\]fluoro- D-glucose (18F-FDG) integrated with computed tomography (CT) in the group of oncological patients.

Conditions

Neoplasms; Antioxidants; Oxidative Stress; Lipid Peroxidation; Inflammation; Lysosome Alteration

Keywords

Positron Emission Tomography Computed Tomography; Fluorodeoxyglucose F18; Cancer; Superooxide Dismutase; Catalase; Glutathione Peroxidase; Malondialdehyde; Conjugated Dienes; Acid Phosphatase; Cathepsin D; Alpha-1-Antitrypsin; Arylsulfatase; 8-iso-Prostaglandin F2alpha; 4-Hydroxynonenal; Total Antioxidant Capacity; Vitamin A; Vitamin E

Outcome Measures

Primary Outcomes (13)

• Superoxide Dismutase

  Antioxidant enzyme

  1 day (Single measurement)

• Catalase

  Antioxidant enzyme

  1 day (Single measurement)

• Glutathione Peroxidase

  Antioxidant enzyme

  1 day (Single measurement)

• Thiobarbituric acid reactive substances (Malondialdehyde)

  Secondary lipid peroxidation product

  1 day (Single measurement)

• Conjugated Dienes

  Primary lipid peroxidation product

  1 day (Single measurement)

• 8-iso-Prostaglandin F2alpha

  Secondary lipid peroxidation product

  1 day (Single measurement)

• 4-Hydroxynonenal

  Secondary lipid peroxidation product

  1 day (Single measurement)

• Total Antioxidant Capacity

  Total antioxidant potential of blood serum in the participant

  1 day (Single measurement)

• Acid Phosphatase

  Lysosomal enzyme

  1 day (Single measurement)

• Cathepsin D

  Lysosomal enzyme

  1 day (Single measurement)

• Arylsulfatase

  Lysosomal enzyme

  1 day (Single measurement)

• Alpha-1-Antitrypsin

  Serine protease inhibitor

  1 day (Single measurement)

• Vitamins A and E

  Low molecular weight antioxidants

  1 day (Single measurement)

Secondary Outcomes (1)

• FDG PET/CT scanning

  1 day (Single measurement)

Study Arms (2)

Patients

Oncological patients: lymphomas (Hodgkin's, DLBCL), breast and ovarian cancers, brain gliomas.

Diagnostic Test: Patients

Control

The number at most half as large as the patients' group, composed of healthy people at similar age and the same sex as patients.

Interventions

Patients DIAGNOSTIC_TEST

The FDG PET/CT imaging will be performed as part of typical medical procedures related to the diagnosis and monitoring of cancers at the Oncology Center in Bydgoszcz, Poland

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients of the Oncology Center in Bydgoszcz, Poland, who suffer from: lymphomas (Hodgkin's, DLBCL), breast and ovarian cancers and brain gliomas. The patients report to the Oncology Center for PET-CT diagnosis. Control group: similar age and the same sex as the patients; number: the half number of the patients.

You may qualify if:

• \- sign informed consent form for participation in the study

You may not qualify if:

• other diseases,
• bad feeling of the studied individual on the day of the study,
• the participants will not be minor and incapacitated persons, soldiers, prisoners and persons dependent in any way from the investigators.

Sponsors & Collaborators

• Nicolaus Copernicus University: lead

Study Sites (3)

The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-092, Poland

Location

Department of Nuclear Medicine of Center Oncology in Bydgoszcz

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

Department of Positron Emission Tomography and Molecular Diagnostics, Collegium Medicum of Nicolaus Copernicus University

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood collected from the basilic vein from the study participants into two vacuum test tubes only once (from patients during FDG PET-CT diagnosis): for full blood (K2EDTA) and blood serum (clot activator and gel separator).

MeSH Terms

Conditions

Neoplasms; Inflammation; Ceroid Lipofuscinosis, Neuronal, 10; alpha 1-Antitrypsin Deficiency

Interventions

Immunocompromised Host

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Subcutaneous Emphysema; Emphysema

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Study Officials

• Paweł Sutkowy, PhD

  The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 20, 2018
• Study Start: June 19, 2017
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (3)