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Completed

NCT Number: NCT05512429

Prognostic Value of Body Composition in 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tuğba Kıratlı Yolcu

Istanbul, 34870, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Unable to access patients data
  • PET/CT CDs cannot be accessed or are not suitable for evaluation.

Treatment and study plan

measured of body composition with computed tomography

Other

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)

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Prognostic Value of Body Composition in Therapy-Naïve Patients With Non-Small Cell Lung Cancer

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 23, 2022
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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