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OpenTrials
Completed

NCT Number: NCT07005115

Serum Lipid Profile and Lip Squamous Cell Carcinoma

The goal of this observational retrospective study is to assess whether serum lipid levels differ between patients diagnosed with lip squamous cell carcinoma (SCC) and healthy individuals. The study aims to evaluate if alterations in lipid parameters, especially LDL levels, are associated with the presence of lip SCC and could serve as potential early biomarkers.

The main research questions are:

Do patients with lip SCC show significantly lower LDL levels compared to healthy controls? Are there significant differences in total cholesterol (TC), triglycerides (TG), HDL, and VLDL between the two groups? A retrospective analysis was conducted using existing medical records of patients with lip SCC and healthy subjects obtained from 2018-2023.

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Key information

About this study

Demographic data and lipid profile information were collected from 56 patients (28 lip SCC and 28 healthy). The lipid parameters included were total cholesterol (TC), triglycerides (TG), high density lipoprotein (HDL), low density lipoprotein (LDL) and very low-density lipoprotein (VLDL).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patients clinically evident and histopathologically confirmed with lip SCC (study group)
  • subjects without any underlying systemic disease (control group)

Exclusion criteria

  • Age younger than 18 years
  • pregnancy
  • smoking
  • history of radiotherapy or chemotherapy
  • family history of hyperlipidemia
  • accompanying malignancies other than lip SCC for both study and control groups

Treatment and study plan

Primary outcomes

  1. Low-Density Lipoprotein (LDL) Levels in Patients With Lip SCC vs. Healthy Controls

    Time frame: At time of diagnosis (retrospective data collection)

    To assess whether there is a statistically significant difference in fasting serum LDL levels between patients diagnosed with lip squamous cell carcinoma (SCC) and healthy subjects.

Secondary outcomes

  1. Total Cholesterol (TC) Levels in Patients With Lip SCC vs. Healthy Controls

    Time frame: At time of diagnosis (retrospective data collection)

    To compare fasting serum total cholesterol (TC) levels between lip SCC patients and healthy controls.

  2. Triglycerides (TG) Levels in Patients With Lip SCC vs. Healthy Controls

    Time frame: At time of diagnosis (retrospective data collection)

    To evaluate fasting serum TG levels in lip SCC patients compared to controls.

  3. High-Density Lipoprotein (HDL) Levels in Patients With Lip SCC vs. Healthy Controls

    Time frame: At time of diagnosis (retrospective data collection)

    To compare HDL levels between lip SCC patients and healthy controls.

  4. Very Low-Density Lipoprotein (VLDL) Levels in Patients With Lip SCC vs. Healthy Controls

    Time frame: At time of diagnosis (retrospective data collection)

    To compare fasting serum VLDL levels between study and control groups.

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

Analysis of Serum Lipid Profile in Patients With Lip Squamous Cell Carcinoma

Important dates

Study start
2018
Primary completion
2021
Study completion
2023
First posted
Jun 5, 2025
Registry last updated
Jun 6, 2025

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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