Body Composition and Non-small Cell Lung CancerNCT05512429
Prognostic Value of Body Composition in Lung Cancer
An observational study of Body Composition and Non-small Cell Lung Cancer, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The effect of body composition on the survival rate is one of the research topics of interest in cancer patients and gaining attention in the last years. Body mass index is often used a proxy measure of total adiposity and previous studies examining the relationship between BMI and cancer outcomes have been showed… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Body Composition and Non-small Cell Lung Cancer
- What is being tested?
- measured of body composition with computed tomography
- Type of treatment
- Injection or infusion
- How many people
- 83 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Jul 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eighty-three patients with stage-IV NSCLC who received at least one cycle of platinum based chemotherapy (PBCT) or tyrosine kinase inhibitor (TKI) therapy and who underwent pre treatment FDG PET/CT from June 2012 to February 2019
Who may be able to join
- Having a pathological diagnosis of non small cell lung cancer
- Having a stage-IV disease
- To have received at least one course of treatment
- Presence of positron emission tomography /computed tomography (PET/CT) examination before treatment and having it taken in our hospital
- The data about the study can be accessed in our center.
- To be over 18 years old
Who cannot join
- Unable to access patients data
- PET/CT CDs cannot be accessed or are not suitable for evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value of Body Composition in Therapy-Naïve Patients With Non-Small Cell Lung Cancer
The effect of body composition on the survival rate is one of the research topics of interest in cancer patients and gaining attention in the last years. Body mass index is often used a proxy measure of total adiposity and previous studies examining the relationship between BMI and cancer outcomes have been showed distinct results . Obese patients with malignancies such as colorectal, breast, and pancreatic cancers, have been shown to have a worse prognosis than normal-weight patients . Nevertheless, obese patients with non small cell lung cancer(NSCLC) have been observed to have a better clinical outcome than normal/low-weight cancer patients . In this study, we examined the effects of subcutaneous adipose tissue, visceral adipose tissue and skeletal muscle volumes on survival in metastatic NSCLC patients under different treatment regimens. Since there is no standard method for adipose tissue measurement, we evaluated the abdominal cavity with multi-slice and single-slice computed tomography measurements.
- Being tested
- measured of body composition with computed tomography
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measured of body composition with computed tomographyOther
Multislice and single-slice computed tomography images were used for assessment of body composition including visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), skeletal muscle mass volume (SMMV)
| Study group | Role | What they receive |
|---|---|---|
| Stage-IV non small cell lung cancer (NSCLC) | Eighty-three patients with stage-IV NSCLC who received at least one cycle of platinum based chemotherapy (PBCT) or tyrosine kinase inhibitor (TKI) therapy and who underwent pre treatment fluorodeoxyglucose (FDG)-positron emission tomography (PET) /computed tomography (FDG PET/CT) from June 2012 to February 2019 Receives: Other: measured of body composition with computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the impact of visceral adipose tissue (VAT) on the prognosis of metastatic non-small cell lung cancer (NSCLC) patients.
Visceral adipose tissue (VAT) area was measured by using computed tomography (CT). The entire abdominopelvic region from the "diaphragm dome" to the "symphysis pubis" level was determined as the study area. The volume was recorded as cm3. Index values were calculated by proportioning VAT to body surface area (BSA) and median index value was determined. The survival rates of patients with an index value greater and less than the mean index value were compared.
Measured: through study completion, an average of 6 months
To evaluate the impact of subcutaneous adipose tissue (SAT) on the prognosis of metastatic non-small cell lung cancer (NSCLC) patients.
Subcutaneous adipose tissue (SAT) area was measured by using computed tomography (CT). The entire abdominopelvic region from the "diaphragm dome" to the "symphysis pubis" level was determined as the study area. The volume was recorded as cm3. Index values were calculated by proportioning SAT to body surface area (BSA) and median index value was determined. The survival rates of patients with an index value greater and less than the mean index value were compared.
Measured: through study completion, an average of 6 months
To evaluate the impact of skeletal muscle mass volume (SMMV) on the prognosis of metastatic non-small cell lung cancer (NSCLC) patients.
Skeletal muscle mass volume (SMMV) area was measured by using computed tomography (CT). For SMMV calculation, paraspinal muscle tissue located between L2-L5 lumbar vertebrae levels was determined . The volume was recorded as cm3. Index values were calculated by proportioning SMMV to body surface area (BSA) and median index value was determined. The survival rates of patients with an index value greater and less than the mean index value were compared.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Jan 2019
- Primary completion1 Jun 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Composition and Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512429
- Sponsor's protocol ID
- 09.2019.1026
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Body Composition in Therapy-Naïve Patients With Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05512429
- Acronym / sponsor ID
- 09.2019.1026
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 23 Aug 2022 (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 effect of body composition on the survival rate is one of the research topics of interest in cancer patients and gaining attention in the last years. Body mass index is often used a proxy measure of total adiposity and previous studies examining the relationship between BMI and cancer outcomes have been showed distinct results . Obese patients with malignancies such as colorectal, breast, and pancreatic cancers, have been shown to have a worse prognosis than normal-weight patients . Nevertheless, obese patients with non small cell lung cancer(NSCLC) have been observed to have a better clinical outcome than normal/low-weight cancer patients . In this study, we examined the effects of subcutaneous adipose tissue, visceral adipose tissue and skeletal muscle volumes on survival in metastatic NSCLC patients under different treatment regimens. Since there is no standard method for adipose tissue measurement, we evaluated the abdominal cavity with multi-slice and single-slice computed tomography measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage-IV non small cell lung cancer (NSCLC) | – | Other: measured of body composition with computed tomographyEighty-three patients with stage-IV NSCLC who received at least one cycle of platinum based chemotherapy (PBCT) or tyrosine kinase inhibitor (TKI) therapy and who underwent pre treatment fluorodeoxyglucose (FDG)-positron emission tomography (PET) /computed tomography (FDG PET/CT) from June 2012 to February 2019 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eighty-three patients with stage-IV NSCLC who received at least one cycle of platinum based chemotherapy (PBCT) or tyrosine kinase inhibitor (TKI) therapy and who underwent pre treatment FDG PET/CT from June 2012 to February 2019
Key inclusion criteria (6 listed)
- Having a pathological diagnosis of non small cell lung cancer
- Having a stage-IV disease
- To have received at least one course of treatment
- Presence of positron emission tomography /computed tomography (PET/CT) examination before treatment and having it taken in our hospital
- The data about the study can be accessed in our center.
Key exclusion criteria (2 listed)
- Unable to access patients data
- PET/CT CDs cannot be accessed or are not suitable for evaluation.
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 |
|---|---|---|
| measured of body composition with computed tomographyMultislice and single-slice computed tomography images were used for assessment of body composition including visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), skeletal muscle mass volume (SMMV) | Other | Stage-IV non small cell lung cancer (NSCLC) |
Primary outcome
To evaluate the impact of visceral adipose tissue (VAT) on the prognosis of metastatic non-small cell lung cancer (NSCLC) patients.
Time frame: through study completion, an average of 6 months
Visceral adipose tissue (VAT) area was measured by using computed tomography (CT). The entire abdominopelvic region from the "diaphragm dome" to the "symphysis pubis" level was determined as the study area. The volume was recorded as cm3. Index values were calculated by proportioning VAT to body surface area (BSA) and median index value was determined. The survival rates of patients with an index value greater and less than the mean index value were compared.
To evaluate the impact of subcutaneous adipose tissue (SAT) on the prognosis of metastatic non-small cell lung cancer (NSCLC) patients.
Time frame: through study completion, an average of 6 months
Subcutaneous adipose tissue (SAT) area was measured by using computed tomography (CT). The entire abdominopelvic region from the "diaphragm dome" to the "symphysis pubis" level was determined as the study area. The volume was recorded as cm3. Index values were calculated by proportioning SAT to body surface area (BSA) and median index value was determined. The survival rates of patients with an index value greater and less than the mean index value were compared.
To evaluate the impact of skeletal muscle mass volume (SMMV) on the prognosis of metastatic non-small cell lung cancer (NSCLC) patients.
Time frame: through study completion, an average of 6 months
Skeletal muscle mass volume (SMMV) area was measured by using computed tomography (CT). For SMMV calculation, paraspinal muscle tissue located between L2-L5 lumbar vertebrae levels was determined . The volume was recorded as cm3. Index values were calculated by proportioning SMMV to body surface area (BSA) and median index value was determined. The survival rates of patients with an index value greater and less than the mean index value were compared.
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 23 Aug 2022.
- Individual participant dataSharing planned: No
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 Body Composition and Non-small Cell Lung Cancer, run by Marmara University at 1 site in Turkey (Türkiye).
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 6 inclusion and 2 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 23 Aug 2022. 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 Turkey (Türkiye). 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?
To evaluate the impact of visceral adipose tissue (VAT) on the prognosis of metastatic non-small cell lung cancer (NSCLC) patients. (time frame: through study completion, an average of 6 months). The study lists 3 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 23 Aug 2022.