Cancer PatientsNCT04037410
Environmental Temperature and White Adipose Tissue in Cancer Patients
An observational study of Cancer Patients, run by Petros Dinas at 1 site in Greece.
Trial summary
The investigators aimed to retrospectively identify the association between the thermogenic capacity of white adipocytes and the environmental temperature, in cancer patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer Patients
- How many people
- 202 participants
- Where
- 1 siteGreece
- Study dates
- 10 May 2019to 31 May 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cancer patients independently of their disease status
Who may be able to join
- Cancer patients who undertook a PET/CT examination independently of their disease status
Who cannot join
- Examinations prior to 2016
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Environmental Temperature on White Adipose Tissue Thermogenic Capacity of Cancer Patients
The investigators aimed to retrospectively identify the association between the thermogenic capacity of white adipocytes and the environmental temperature, in cancer patients.
Read the detailed description
Obesity is characterized by excessive white adipose tissue (WAT) that increases risk for disease. About 700 million adults are obese worldwide, designating the need of reducing excessive WAT in humans and subsequently the risk for disease. For this reason, previous research focused on the thermogenic capacity of white adipocytes in response to cold exposure. Cold exposure represents a main stimulus for increased thermogenic capacity in human white adipocytes, which may have an impact on body weight loss and subsequently on obesity phenomenon.
In a cohort of 202 cancer patients (male=126), who undertook a Positron Emission Tomography (PET/CT), we retrospectively investigated the association between Tenv and thermogenic capacity of subcutaneous WAT (dorsolumbar region near vertebrae L3 and abdominal region). These patients undertook a PET/CT examination in order to define their disease status. They were given instructions in advance to refrain from smoking, exercise and excessive muscle stressors 24-hour prior to their examination. On the day of the measurements they advised to transport themselves by car to the PET/CT Laboratory between 08:00 am to 12 pm, following at least a 6-hour fasting. Patients were first injected an appropriate dose of 18F-FDG (based on their body weight) and then they were remained in a sitting relaxed position within a quiet room of 22-24°C for 60 minutes. Following this period, patients undertook the PET/CT examination, which included on average eight bed positions, while four minutes scanning per bed position was used.
PET/CT imaging analysis for WAT activity (dorsolumbar region near vertebrae L3 and abdominal region) was performed by two independent trained physicians, using previous methodology.
- Conditions
- Cancer Patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of thermogenic capacity of white adipocytes
Thermogenic capacity of white adipocytes was measured via Positron Emission Tomography/computed tomography (PET/CT) device, unit of measurement: Standardized Uptake Value (SUV)
Measured: The SUV of white adipocytes for each patient was measured once via the PET/CT software between 10-30 May 2019.
Environmental temperature
The daily environmental temperature was obtained in degrees Celsius for the period 1-1-2016 to 30-4-2019.
Measured: The daily environmental temperature was obtained from Weather Underground (www.wunderground.com) on the 10th May 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start10 May 2019
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PatientsStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petros Dinas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Petros Dinas, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037410
- Sponsor's protocol ID
- 2. Tenv & cancer patient
- Status last verified
- Jul 2019
- First submitted
- 25 Jul 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Environmental Temperature on White Adipose Tissue Thermogenic Capacity of Cancer Patients
- ClinicalTrials.gov ID
- NCT04037410
- Acronym / sponsor ID
- 2. Tenv & cancer patient
- Conditions
- Cancer Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Petros DinasUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 30 Jul 2019 (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 investigators aimed to retrospectively identify the association between the thermogenic capacity of white adipocytes and the environmental temperature, in cancer patients.
Detailed description
Obesity is characterized by excessive white adipose tissue (WAT) that increases risk for disease. About 700 million adults are obese worldwide, designating the need of reducing excessive WAT in humans and subsequently the risk for disease. For this reason, previous research focused on the thermogenic capacity of white adipocytes in response to cold exposure. Cold exposure represents a main stimulus for increased thermogenic capacity in human white adipocytes, which may have an impact on body weight loss and subsequently on obesity phenomenon.
In a cohort of 202 cancer patients (male=126), who undertook a Positron Emission Tomography (PET/CT), we retrospectively investigated the association between Tenv and thermogenic capacity of subcutaneous WAT (dorsolumbar region near vertebrae L3 and abdominal region). These patients undertook a PET/CT examination in order to define their disease status. They were given instructions in advance to refrain from smoking, exercise and excessive muscle stressors 24-hour prior to their examination. On the day of the measurements they advised to transport themselves by car to the PET/CT Laboratory between 08:00 am to 12 pm, following at least a 6-hour fasting. Patients were first injected an appropriate dose of 18F-FDG (based on their body weight) and then they were remained in a sitting relaxed position within a quiet room of 22-24°C for 60 minutes. Following this period, patients undertook the PET/CT examination, which included on average eight bed positions, while four minutes scanning per bed position was used.
PET/CT imaging analysis for WAT activity (dorsolumbar region near vertebrae L3 and abdominal region) was performed by two independent trained physicians, using previous methodology.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cancer patients independently of their disease status
Key inclusion criteria (1 listed)
- Cancer patients who undertook a PET/CT examination independently of their disease status
Key exclusion criteria (1 listed)
- Examinations prior to 2016
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of thermogenic capacity of white adipocytes
Time frame: The SUV of white adipocytes for each patient was measured once via the PET/CT software between 10-30 May 2019.
Thermogenic capacity of white adipocytes was measured via Positron Emission Tomography/computed tomography (PET/CT) device, unit of measurement: Standardized Uptake Value (SUV)
Environmental temperature
Time frame: The daily environmental temperature was obtained from Weather Underground (www.wunderground.com) on the 10th May 2019
The daily environmental temperature was obtained in degrees Celsius for the period 1-1-2016 to 30-4-2019.
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 30 Jul 2019.
Related trials for Cancer Patients
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Patients, run by Petros Dinas at 1 site in Greece.
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 1 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 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
Assessment of thermogenic capacity of white adipocytes (time frame: The SUV of white adipocytes for each patient was measured once via the PET/CT software between 10-30 May 2019.). The study lists 2 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 30 Jul 2019.