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临床试验/CTRI/2024/07/069961
CTRI/2024/07/069961尚未招募不适用

Serum Vitamin D levels in patients with Oral squamous cell carcinoma and potentially malignant lesions - a comparative study.

Dr Srikanth G1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2024年7月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
81
试验地点
1
主要终点
Vitamin D levels in patients with Oral SCC and Oral Potentially malignant lesions

研究概览

简要总结

Vitamin D deficiency is frequently observed in human cancer patients and a prognostic relevance could be shown for some entities. A low serum level of 25-hydroxy vitamin D, the principal form of circulating vitamin D, is the main marker of vitamin D deficiency and is studied to have a potent anti-neoplastic activity in the management of several human malignancies. Few systemic reviews are available which have observed that there exists a relationship between vitamin D and cancerous cells. It’s noted that this works by enhancing anti-proliferation and pro-apoptotic factors, as well as inhibition of cell-cycle promoters and growth factor signalling pathway., thus inhibiting cancer cell proliferation. Thus, Vitamin D is a pro-apoptotic factor and is a useful anti-neoplastic agent. Through this study we aim to validate this correlation and acknowledge the relationship if any between the prevalence of oral squamous cell carcinoma and serum vitamin D levels

Patients presenting to Department of oral maxillofacial surgery with a clinical diagnosis of oral squamous cell carcinoma (Group A) or potentially malignant lesion (Group B) will be included in this study. Cancer free healthy patients who are willing to be part of the study would be included as controls (Group C). Patients in Group A and Group B, as per protocol, require to be biopsied to have confirmatory diagnosis. Prior to biopsy these patients are sent for routine blood tests for evaluation of Complete blood picture, biochemistry analysis like blood glucose, serum electrolyte, etc. and bleeding and clotting time evaluation. During these blood sampling the patient will be asked for additional tests for Vitamin D analysis. Patients in Group C will comprise of patients with no suspected intra-oral lesion, however, undergoing any minor surgical procedure which will require prior blood tests.

Informed consent of the patients will be obtained. Information on age, sex, tobacco habit status would be collected. Histopathological differentiation would be recorded from oral squamous cell carcinoma. Type of potentially malignant lesion would also be recorded.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients with no suspicion of Oral SCC or premalignant lesion visiting department of oral maxillofacial surgery who expresses their willingness to be part of the study and require Vitamin D assessment as a standard of care.
  • Patients visiting department of oral maxillofacial surgery with histologically diagnosed oral squamous cell cancer or potential malignant lesions.

排除标准

  • Patients with recurrent cancer or already under the treatment.
  • Participants who are under any type of vitamin D supplements/calcium in the last one year.

结局指标

主要结局

Vitamin D levels in patients with Oral SCC and Oral Potentially malignant lesions

时间窗: Baseline

次要结局

  • 1. Comparison of histopathological grades of OSCC & Serum vitamin D levels.(2. Comparison of different potentially malignant lesions & Serum vitamin D levels.)

研究者

发起方
Dr Srikanth G
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Srikanth G

Manipal College of Dental Sciences, Manipal

研究点 (1)

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