Serum Lipid Profile and Lip Squamous Cell Carcinoma

NCT07005115 | Completed

• 1 other identifier: 22032023/250
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Lipid Profile; Lipids; SCC - Squamous Cell Carcinoma; Lip Cancer; Oral Cancer

Keywords

Oral Cancer; Lipids; Lipid Levels; Non-Smokers; Lip Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

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

  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.

  At time of diagnosis (retrospective data collection)

Secondary Outcomes (4)

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

  At time of diagnosis (retrospective data collection)

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

  At time of diagnosis (retrospective data collection)

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

  At time of diagnosis (retrospective data collection)

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

  At time of diagnosis (retrospective data collection)

Study Arms (2)

study group

patients clinically evident and histopathologically confirmed with lip SCC

control group

subjects without any underlying systemic disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, 07070, Turkey (Türkiye)

Location

Related Publications (15)

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  PMID: 20002982 BACKGROUND

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  PMID: 6799076 BACKGROUND

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  PMID: 25097644 BACKGROUND

• Kumar P, Augustine J, Urs AB, Arora S, Gupta S, Mohanty VR. Serum lipid profile in oral cancer and leukoplakia: correlation with tobacco abuse and histological grading. J Cancer Res Ther. 2012 Jul-Sep;8(3):384-8. doi: 10.4103/0973-1482.103517.

  PMID: 23174719 BACKGROUND

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  PMID: 9840100 BACKGROUND

• Neville BW, Day TA. Oral cancer and precancerous lesions. CA Cancer J Clin. 2002 Jul-Aug;52(4):195-215. doi: 10.3322/canjclin.52.4.195.

  PMID: 12139232 BACKGROUND

• Patel PS, Shah MH, Jha FP, Raval GN, Rawal RM, Patel MM, Patel JB, Patel DD. Alterations in plasma lipid profile patterns in head and neck cancer and oral precancerous conditions. Indian J Cancer. 2004 Jan-Mar;41(1):25-31.

  PMID: 15105576 BACKGROUND

• Alexopoulos CG, Blatsios B, Avgerinos A. Serum lipids and lipoprotein disorders in cancer patients. Cancer. 1987 Dec 15;60(12):3065-70. doi: 10.1002/1097-0142(19871215)60:123.0.co;2-q.

  PMID: 3677028 BACKGROUND

• Acharya S, Rai P, Hallikeri K, Anehosur V, Kale J. Serum lipid profile in oral squamous cell carcinoma: alterations and association with some clinicopathological parameters and tobacco use. Int J Oral Maxillofac Surg. 2016 Jun;45(6):713-20. doi: 10.1016/j.ijom.2016.01.015. Epub 2016 Feb 19.

  PMID: 26899131 BACKGROUND

• Bota JP, Lyons AB, Carroll BT. Squamous Cell Carcinoma of the Lip-A Review of Squamous Cell Carcinogenesis of the Mucosal and Cutaneous Junction. Dermatol Surg. 2017 Apr;43(4):494-506. doi: 10.1097/DSS.0000000000001020.

  PMID: 28157733 BACKGROUND

• Moro JDS, Maroneze MC, Ardenghi TM, Barin LM, Danesi CC. Oral and oropharyngeal cancer: epidemiology and survival analysis. Einstein (Sao Paulo). 2018 Jun 7;16(2):eAO4248. doi: 10.1590/S1679-45082018AO4248.

  PMID: 29898090 BACKGROUND

• Han AY, Kuan EC, Mallen-St Clair J, Alonso JE, Arshi A, St John MA. Epidemiology of Squamous Cell Carcinoma of the Lip in the United States: A Population-Based Cohort Analysis. JAMA Otolaryngol Head Neck Surg. 2016 Dec 1;142(12):1216-1223. doi: 10.1001/jamaoto.2016.3455.

  PMID: 27832256 BACKGROUND

• Louredo BV, Vargas PA, Perez-de-Oliveira ME, Lopes MA, Kowalski LP, Curado MP. Epidemiology and survival outcomes of lip, oral cavity, and oropharyngeal squamous cell carcinoma in a southeast Brazilian population. Med Oral Patol Oral Cir Bucal. 2022 May 1;27(3):e274-e284. doi: 10.4317/medoral.25147.

  PMID: 35368013 BACKGROUND

• Tranby EP, Heaton LJ, Tomar SL, Kelly AL, Fager GL, Backley M, Frantsve-Hawley J. Oral Cancer Prevalence, Mortality, and Costs in Medicaid and Commercial Insurance Claims Data. Cancer Epidemiol Biomarkers Prev. 2022 Sep 2;31(9):1849-1857. doi: 10.1158/1055-9965.EPI-22-0114.

  PMID: 35732291 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Lip Neoplasms; Mouth Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Neoplasms by Site; Lip Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Eldar Rasljanin, DDS

  Akdeniz University, Antalya, Turkiye

  PRINCIPAL INVESTIGATOR

• Özer Erdem Gür, MD

  Antalya Training and Research Hospital, University of Health Science, Antalya, Turkiye

  PRINCIPAL INVESTIGATOR

• Rezarta Taga Senirli, MD

  Antalya Training and Research Hospital, University of Health Science, Antalya, Turkiye

  PRINCIPAL INVESTIGATOR

• Busehan Bilgin, DDS

  Akdeniz University, Antalya, Turkiye

  PRINCIPAL INVESTIGATOR

• Öznur Özalp, DDS

  Akdeniz University, Antalya, Turkiye

  PRINCIPAL INVESTIGATOR

• Mehmet Ali Altay, DDS, PhD

  Akdeniz University, Antalya, Turkiye

  PRINCIPAL INVESTIGATOR

• Alper Sindel, DDS, PhD

  Akdeniz University, Antalya, Turkiye

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 5, 2025
• Study Start: January 1, 2018
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2023
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

TU (1)