Clinical trial NCT07005115: Serum Lipid Profile and Lip Squamous Cell Carcinoma
Official title: Analysis of Serum Lipid Profile in Patients With Lip Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lipid Profile
Lipids
SCC - Squamous Cell Carcinoma
Lip Cancer
Oral Cancer
Keywords: Oral Cancer
Lipids
Lipid Levels
Non-Smokers
Lip Squamous Cell Carcinoma
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data from patients with a histopathological diagnosis of primary lip cancers at Antalya Training and Research Hospital, Turkiye.

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Low-Density Lipoprotein (LDL) Levels in Patients With Lip SCC vs. Healthy Controls
timeFrame: At time of diagnosis (retrospective data collection)
Secondary outcomes:
measure: Total Cholesterol (TC) Levels in Patients With Lip SCC vs. Healthy Controls
timeFrame: At time of diagnosis (retrospective data collection)
measure: Triglycerides (TG) Levels in Patients With Lip SCC vs. Healthy Controls
timeFrame: At time of diagnosis (retrospective data collection)
measure: High-Density Lipoprotein (HDL) Levels in Patients With Lip SCC vs. Healthy Controls
timeFrame: At time of diagnosis (retrospective data collection)
measure: Very Low-Density Lipoprotein (VLDL) Levels in Patients With Lip SCC vs. Healthy Controls
timeFrame: At time of diagnosis (retrospective data collection)
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
affiliation: Akdeniz University, Antalya, Turkiye
name: Eldar Rasljanin, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Antalya Training and Research Hospital, University of Health Science, Antalya, Turkiye
name: Özer Erdem Gür, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Antalya Training and Research Hospital, University of Health Science, Antalya, Turkiye
name: Rezarta Taga Senirli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Akdeniz University, Antalya, Turkiye
name: Busehan Bilgin, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Akdeniz University, Antalya, Turkiye
name: Öznur Özalp, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Akdeniz University, Antalya, Turkiye
name: Mehmet Ali Altay, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Akdeniz University, Antalya, Turkiye
name: Alper Sindel, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
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