Lipid ProfileNCT07005115
Serum Lipid Profile and Lip Squamous Cell Carcinoma
An observational study of Lipid Profile and Lipids, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lipid Profile, Lipids, SCC - Squamous Cell Carcinoma
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Jan 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Data from patients with a histopathological diagnosis of primary lip cancers at Antalya Training and Research Hospital, Turkiye.
Who may be able to join
- patients clinically evident and histopathologically confirmed with lip SCC (study group)
- subjects without any underlying systemic disease (control group)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Serum Lipid Profile in Patients With 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.
Read the 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).
- Conditions
- Lipid Profile, Lipids, SCC - Squamous Cell Carcinoma, Lip Cancer, Oral Cancer
- Keywords
- Oral Cancer, Lipids, Lipid Levels, Non-Smokers, Lip Squamous Cell Carcinoma
- Medical subject headings
- Carcinoma, Squamous Cell, Lip Neoplasms, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | patients clinically evident and histopathologically confirmed with lip SCC | |
| control group | subjects without any underlying systemic disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At time of diagnosis (retrospective data collection)
Secondary outcomes (4)
Total Cholesterol (TC) Levels in Patients With Lip SCC vs. Healthy Controls
To compare fasting serum total cholesterol (TC) levels between lip SCC patients and healthy controls.
Measured: At time of diagnosis (retrospective data collection)
Triglycerides (TG) Levels in Patients With Lip SCC vs. Healthy Controls
To evaluate fasting serum TG levels in lip SCC patients compared to controls.
Measured: At time of diagnosis (retrospective data collection)
High-Density Lipoprotein (HDL) Levels in Patients With Lip SCC vs. Healthy Controls
To compare HDL levels between lip SCC patients and healthy controls.
Measured: At time of diagnosis (retrospective data collection)
Very Low-Density Lipoprotein (VLDL) Levels in Patients With Lip SCC vs. Healthy Controls
To compare fasting serum VLDL levels between study and control groups.
Measured: At time of diagnosis (retrospective data collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Jan 2018
- Primary completion1 Jan 2021
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Lipid ProfileStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper Sindel, Akdeniz University
- Investigators
- Eldar Rasljanin, DDS, Principal investigator, Akdeniz University, Antalya, TurkiyeÖzer Erdem Gür, MD, Principal investigator, Antalya Training and Research Hospital, University of Health Science, Antalya, TurkiyeRezarta Taga Senirli, MD, Principal investigator, Antalya Training and Research Hospital, University of Health Science, Antalya, TurkiyeBusehan Bilgin, DDS, Principal investigator, Akdeniz University, Antalya, TurkiyeÖznur Özalp, DDS, Principal investigator, Akdeniz University, Antalya, TurkiyeMehmet Ali Altay, DDS, PhD, Principal investigator, Akdeniz University, Antalya, TurkiyeAlper Sindel, DDS, PhD, Principal investigator, Akdeniz University, Antalya, Turkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005115
- Sponsor's protocol ID
- 22032023/250
- Status last verified
- Jun 2025
- First submitted
- 27 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lohe VK, Degwekar SS, Bhowate RR, Kadu RP, Dangore SB. Evaluation of correlation of serum lipid profile in patients with oral cancer and precancer and its association with tobacco abuse. J Oral Pathol Med. 2010 Feb;39(2):141-8. doi: 10.1111/j.1600-0714.2009.00828.x. Epub 2009 Dec 7.
PubMed 20002982Kark JD, Smith AH, Hames CG. Serum retinol and the inverse relationship between serum cholesterol and cancer. Br Med J (Clin Res Ed). 1982 Jan 16;284(6310):152-4. doi: 10.1136/bmj.284.6310.152.
PubMed 6799076Mehta R, Gurudath S, Dayansoor S, Pai A, Ganapathy KS. Serum lipid profile in patients with oral cancer and oral precancerous conditions. Dent Res J (Isfahan). 2014 May;11(3):345-50. doi: 10.4103/1735-3327.135889.
PubMed 25097644Kumar 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.
PubMed 23174719Gerber M, Richardson S, Crastes de Paulet P, Pujol H, Crastes de Paulet A. Relationship between vitamin E and polyunsaturated fatty acids in breast cancer. Nutritional and metabolic aspects. Cancer. 1989 Dec 1;64(11):2347-53. doi: 10.1002/1097-0142(19891201)64:113.0.co;2-v.
PubMed 2804926Forones NM, Falcao JB, Mattos D, Barone B. Cholesterolemia in colorectal cancer. Hepatogastroenterology. 1998 Sep-Oct;45(23):1531-4.
PubMed 9840100Neville 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.
PubMed 12139232Patel 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.
PubMed 15105576Alexopoulos 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.
PubMed 3677028Acharya 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.
PubMed 26899131Bota 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.
PubMed 28157733Moro 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.
PubMed 29898090Han 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.
PubMed 27832256Louredo 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.
PubMed 35368013Tranby 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.
PubMed 35732291
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Serum Lipid Profile in Patients With Lip Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07005115
- Acronym / sponsor ID
- 22032023/250
- Conditions
- Lipid Profile, Lipids, SCC - Squamous Cell Carcinoma, Lip Cancer, Oral Cancer
- Keywords
- Oral Cancer, Lipids, Lipid Levels, Non-Smokers, Lip Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 5 Jun 2025 (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 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).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | –patients clinically evident and histopathologically confirmed with lip SCC |
| control group | – | –subjects without any underlying systemic disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Data from patients with a histopathological diagnosis of primary lip cancers at Antalya Training and Research Hospital, Turkiye.
Key inclusion criteria (2 listed)
- patients clinically evident and histopathologically confirmed with lip SCC (study group)
- subjects without any underlying systemic disease (control group)
Key exclusion criteria (6 listed)
- Age younger than 18 years
- pregnancy
- smoking
- history of radiotherapy or chemotherapy
- family history of hyperlipidemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Total Cholesterol (TC) Levels in Patients With Lip SCC vs. Healthy Controls
Time frame: At time of diagnosis (retrospective data collection)
Triglycerides (TG) Levels in Patients With Lip SCC vs. Healthy Controls
Time frame: At time of diagnosis (retrospective data collection)
High-Density Lipoprotein (HDL) Levels in Patients With Lip SCC vs. Healthy Controls
Time frame: At time of diagnosis (retrospective data collection)
Very Low-Density Lipoprotein (VLDL) Levels in Patients With Lip SCC vs. Healthy Controls
Time frame: At time of diagnosis (retrospective data collection)
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 6 Jun 2025.
- Background: PubMed 20002982Lohe VK, Degwekar SS, Bhowate RR, Kadu RP, Dangore SB. Evaluation of correlation of serum lipid profile in patients with oral cancer and precancer and its association with tobacco abuse. J Oral Pathol Med. 2010 Feb;39(2):141-8. doi: 10.1111/j.1600-0714.2009.00828.x. Epub 2009 Dec 7.
- Background: PubMed 6799076Kark JD, Smith AH, Hames CG. Serum retinol and the inverse relationship between serum cholesterol and cancer. Br Med J (Clin Res Ed). 1982 Jan 16;284(6310):152-4. doi: 10.1136/bmj.284.6310.152.
- Background: PubMed 25097644Mehta R, Gurudath S, Dayansoor S, Pai A, Ganapathy KS. Serum lipid profile in patients with oral cancer and oral precancerous conditions. Dent Res J (Isfahan). 2014 May;11(3):345-50. doi: 10.4103/1735-3327.135889.
- Background: PubMed 23174719Kumar 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.
- Background: PubMed 2804926Gerber M, Richardson S, Crastes de Paulet P, Pujol H, Crastes de Paulet A. Relationship between vitamin E and polyunsaturated fatty acids in breast cancer. Nutritional and metabolic aspects. Cancer. 1989 Dec 1;64(11):2347-53. doi: 10.1002/1097-0142(19891201)64:113.0.co;2-v.
- Background: PubMed 9840100Forones NM, Falcao JB, Mattos D, Barone B. Cholesterolemia in colorectal cancer. Hepatogastroenterology. 1998 Sep-Oct;45(23):1531-4.
- Background: PubMed 12139232Neville 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.
- Background: PubMed 15105576Patel 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.
- Background: PubMed 3677028Alexopoulos 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.
- Background: PubMed 26899131Acharya 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.
- Background: PubMed 28157733Bota 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.
- Background: PubMed 29898090Moro 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.
- Individual participant dataSharing planned: Undecided
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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.
Eldar Rasljanin, DDS principal investigator
Akdeniz University, Antalya, Turkiye
Özer Erdem Gür, MD principal investigator
Antalya Training and Research Hospital, University of Health Science, Antalya, Turkiye
Rezarta Taga Senirli, MD principal investigator
Antalya Training and Research Hospital, University of Health Science, Antalya, Turkiye
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 Lipid Profile and Lipids, run by Akdeniz 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 2 inclusion and 6 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 6 Jun 2025. 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?
Low-Density Lipoprotein (LDL) Levels in Patients With Lip SCC vs. Healthy Controls (time frame: At time of diagnosis (retrospective data collection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07005115, which also lists 15 linked publications.
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 6 Jun 2025.