A prospective, multi-centre, single arm, pilot clinical study to determine the accuracy of the ERLY SIGN Kit for early detection of Oral Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- To evaluate the sensitivity and specificity of the ERLY SIGN Kit in identifying the active levels of MMP-2 and/or MMP-9 in saliva for early detection of Oral Cancer as compared to gold standard (Biopsy results)
研究概览
简要总结
This study is a prospective, multi-center, non-randomized, pilot clinical study. Subject to inclusion, exclusion criteria and after obtaining an informed consent, subjects will be enrolled in the study. The ERLY SIGN Kit shall be used for the early detection of Oral Cancer. The study shall be done at 3+ sites with a total number of 1000 patients that meet the criteria for inclusion. The study duration is expected to be approximately 6-8 months.
Defined parameters shall be recorded during the study and entered in the work sheet/CRF.
Premalignant subjects, with high levels of MMP-2 and/or MMP-9 will undergo histopathological examination. Those subjects identified as positive will be considered as true positive and those with negative results will undergo a comprehensive 3-month follow-up, involving re-examination with our kit and histopathological analysis, to rigorously confirm the trajectory of disease progression. This follow up design will help us arrive at a conclusion about the utility of our kit in predicting the malignant progression of the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •The inclusion criteria are as follows: • Male or Female patients with age of eighteen (18) and above.
- •â€¢ Able to give informed consent.
- •â€¢ Patients meeting the inclusion criteria for one of the following study groups: Group A: 400 Healthy Individuals Patients who give a history of: • No smoking • No tobacco • No alcohol • No systemic disease on conventional oral examination • No visible oral lesions on conventional oral examination.
- •â€¢ Good oral hygiene.
- •Group B: 200 subjects with suspected Oral Carcinoma diagnosed with Premalignant oral lesions such as leukoplakia, erythroplakia, lichen planus, and submucous fibrosis.
- •Group C: 400 subjects with confirmed diagnosis of Oral Carcinoma.
- •Patient must be diagnosed with histologically confirmed oral cavity squamous cell carcinoma (OCC) (lip, floor of mouth, anterior 2/3 tongue, buccal mucosa, upper and lower gingiva, hard palate and retromolar trigone.
排除标准
- •The exclusion criteria are as follows: •Patients who have participated in another investigational clinical study within thirty (30) days before screening.
- •â€¢Inflammation, Cut or fissures in the oral cavity which was not preview of the Oral Cancer.
- •â€¢Uncontrolled hypertension, diabetes mellitus or any other co-morbidity that is considered as an exclusion by the Investigator.
- •â€¢ Dementia or significantly altered mental status that would limit the ability to obtain informed consent and compliance with the requirements of this protocol.
- •â€¢Patients with a history of cancer other than for selected group •Significant medical history, immune-compromised and patients with COVID19 illness at present.
- •â€¢Subjects with any other clinically significant unstable medical condition, life-threatening disease, which in the opinion of the Investigator that would interfere with the study results.
- •â€¢ Any acute or chronic medical, psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or could interfere with interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry in the trial.
- •â€¢ Inability/lack of willingness to comply with visits, treatment plans, protocol assessments or laboratory tests.
结局指标
主要结局
To evaluate the sensitivity and specificity of the ERLY SIGN Kit in identifying the active levels of MMP-2 and/or MMP-9 in saliva for early detection of Oral Cancer as compared to gold standard (Biopsy results)
时间窗: 1 day
次要结局
- •To have a predictive scale about the progression of patients with premalignant oral lesions with highly active MMP-2 and/or MMP-9 level in the saliva to malignant oral cancer(•To calculate the correlative index of progression of patients with premalignant oral lesions with highly active levels of active MMP-2 and/or MMP-9 in the saliva to malignant oral cancer)
研究者
Dr Ashwini Kumar
CliniExperts Research Services Pvt Ltd