NeoplasmsNCT03470857
Oxidoreductive Balance and Lysosomal Activity in Cancer Patients.
An observational study of Neoplasms and Antioxidants, run by Nicolaus Copernicus University at 3 sites in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neoplasms, Antioxidants, Oxidative Stress
- What is being tested?
- Patients
- How many people
- 83 participants
- Where
- 3 sitesPoland
- Study dates
- 19 Jun 2017to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- sign informed consent form for participation in the study
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Poland3 sites
The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-092
Department of Nuclear Medicine of Center Oncology in Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796
Department of Positron Emission Tomography and Molecular Diagnostics, Collegium Medicum of Nicolaus Copernicus University
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796
About this study
Official title: Oxidative Stress and Inflammatory Processes in Selected Neoplasms in the Group of Oncological Patients Examined With the FDG PET/CT Method.
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.
Read the detailed description
FDG PET/CT is very sensitive imaging tool for the detection of neoplasms. Neoplasm tissue is characterized by a much higher level of metabolism than healthy tissues, therefore a 95% cases of use the method regard oncology. Fluorodeoxyglucose (FDG) is absorbed by patients' organism as glucose but it does not undergo metabolism. The increased degree of FDG accumulation in tissue means its higher metabolic activity. FDG accumulates in the tumor tissue and radiates enabling its detection but the substance has not been shown to be harmful to patient at doses used in the diagnostics.
Tumor formation is a multi-stage process in which the phases of initiation, promotion and progression are distinguished. Neoplastic transformation of healthy cells is associated with disturbances of the cell cycle caused by mutations of proto-oncogenes (activation of cell division) and/or suppressor genes (blocking cell division) and mutator genes (protecting the DNA against damage or its repairing) under the influence of various factors. Increasing data indicate that one of the most important factors initiating neoplasm are reactive oxygen species (ROS) and oxidative stress. Mechanisms responsible for induction of oxidative stress in cancer cells are not fully explained. It is known that they are closely related to inflammation, as well as intense cellular metabolism associated with continuous proliferation, mutations in the genetic material and dysfunctions in the mitochondrial respiratory chain.
In this study a number of markers of oxidative stress and inflammation are planned to be determined including: the activities of antioxidant and lysosomal enzymes, as well as concentrations of lipid peroxidation products and low molecular weight antioxidants. The PET/CT imaging will be performed as part of standard medical procedures related to the diagnosis and monitoring of cancer diseases at the Oncology Center in Bydgoszcz, Poland.
- Conditions
- Neoplasms, Antioxidants, Oxidative Stress, Lipid Peroxidation, Inflammation, Lysosome Alteration
- Being tested
- Patients
- 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
- Medical subject headings
- Neoplasms, Inflammation, Ceroid Lipofuscinosis, Neuronal, 10, alpha 1-Antitrypsin Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatientsDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Patients | Oncological patients: lymphomas (Hodgkin's, DLBCL), breast and ovarian cancers, brain gliomas. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superoxide Dismutase
Antioxidant enzyme
Measured: 1 day (Single measurement)
Catalase
Antioxidant enzyme
Measured: 1 day (Single measurement)
Glutathione Peroxidase
Antioxidant enzyme
Measured: 1 day (Single measurement)
Thiobarbituric acid reactive substances (Malondialdehyde)
Secondary lipid peroxidation product
Measured: 1 day (Single measurement)
Conjugated Dienes
Primary lipid peroxidation product
Measured: 1 day (Single measurement)
8-iso-Prostaglandin F2alpha
Secondary lipid peroxidation product
Measured: 1 day (Single measurement)
4-Hydroxynonenal
Secondary lipid peroxidation product
Measured: 1 day (Single measurement)
Total Antioxidant Capacity
Total antioxidant potential of blood serum in the participant
Measured: 1 day (Single measurement)
Acid Phosphatase
Lysosomal enzyme
Measured: 1 day (Single measurement)
Cathepsin D
Lysosomal enzyme
Measured: 1 day (Single measurement)
Arylsulfatase
Lysosomal enzyme
Measured: 1 day (Single measurement)
Alpha-1-Antitrypsin
Serine protease inhibitor
Measured: 1 day (Single measurement)
Vitamins A and E
Low molecular weight antioxidants
Measured: 1 day (Single measurement)
Secondary outcomes (1)
FDG PET/CT scanning
Positron emission tomography with 2-deoxy-2-[fluorine-18]fluoro- D-glucose integrated with computed tomography
Measured: 1 day (Single measurement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start19 Jun 2017
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicolaus Copernicus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paweł Sutkowy, Nicolaus Copernicus University
- Investigators
- Paweł Sutkowy, PhD, Principal investigator, The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470857
- Sponsor's protocol ID
- KB 363/2017
- Status last verified
- Sep 2022
- First submitted
- 13 Mar 2018
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no the individual participant data (IPD) sharing plan.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidative Stress and Inflammatory Processes in Selected Neoplasms in the Group of Oncological Patients Examined With the FDG PET/CT Method.
- ClinicalTrials.gov ID
- NCT03470857
- Acronym / sponsor ID
- KB 363/2017
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Nicolaus Copernicus UniversityUniversity, hospital or other
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 20 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
FDG PET/CT is very sensitive imaging tool for the detection of neoplasms. Neoplasm tissue is characterized by a much higher level of metabolism than healthy tissues, therefore a 95% cases of use the method regard oncology. Fluorodeoxyglucose (FDG) is absorbed by patients' organism as glucose but it does not undergo metabolism. The increased degree of FDG accumulation in tissue means its higher metabolic activity. FDG accumulates in the tumor tissue and radiates enabling its detection but the substance has not been shown to be harmful to patient at doses used in the diagnostics.
Tumor formation is a multi-stage process in which the phases of initiation, promotion and progression are distinguished. Neoplastic transformation of healthy cells is associated with disturbances of the cell cycle caused by mutations of proto-oncogenes (activation of cell division) and/or suppressor genes (blocking cell division) and mutator genes (protecting the DNA against damage or its repairing) under the influence of various factors. Increasing data indicate that one of the most important factors initiating neoplasm are reactive oxygen species (ROS) and oxidative stress. Mechanisms responsible for induction of oxidative stress in cancer cells are not fully explained. It is known that they are closely related to inflammation, as well as intense cellular metabolism associated with continuous proliferation, mutations in the genetic material and dysfunctions in the mitochondrial respiratory chain.
In this study a number of markers of oxidative stress and inflammation are planned to be determined including: the activities of antioxidant and lysosomal enzymes, as well as concentrations of lipid peroxidation products and low molecular weight antioxidants. The PET/CT imaging will be performed as part of standard medical procedures related to the diagnosis and monitoring of cancer diseases at the Oncology Center in Bydgoszcz, Poland.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: PatientsOncological patients: lymphomas (Hodgkin's, DLBCL), breast and ovarian cancers, brain gliomas. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- sign informed consent form for participation in the study
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PatientsThe 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 | Diagnostic test | Patients |
Primary outcome
Superoxide Dismutase
Time frame: 1 day (Single measurement)
Antioxidant enzyme
Catalase
Time frame: 1 day (Single measurement)
Antioxidant enzyme
Glutathione Peroxidase
Time frame: 1 day (Single measurement)
Antioxidant enzyme
Thiobarbituric acid reactive substances (Malondialdehyde)
Time frame: 1 day (Single measurement)
Secondary lipid peroxidation product
Conjugated Dienes
Time frame: 1 day (Single measurement)
Primary lipid peroxidation product
8-iso-Prostaglandin F2alpha
Time frame: 1 day (Single measurement)
Secondary lipid peroxidation product
4-Hydroxynonenal
Time frame: 1 day (Single measurement)
Secondary lipid peroxidation product
Total Antioxidant Capacity
Time frame: 1 day (Single measurement)
Total antioxidant potential of blood serum in the participant
Acid Phosphatase
Time frame: 1 day (Single measurement)
Lysosomal enzyme
Cathepsin D
Time frame: 1 day (Single measurement)
Lysosomal enzyme
Arylsulfatase
Time frame: 1 day (Single measurement)
Lysosomal enzyme
Alpha-1-Antitrypsin
Time frame: 1 day (Single measurement)
Serine protease inhibitor
Vitamins A and E
Time frame: 1 day (Single measurement)
Low molecular weight antioxidants
1 secondary outcome
FDG PET/CT scanning
Time frame: 1 day (Single measurement)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No. There is no the individual participant data (IPD) sharing plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paweł Sutkowy, PhD principal investigator
The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Antioxidants, run by Nicolaus Copernicus University at 3 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superoxide Dismutase (time frame: 1 day (Single measurement)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.