A prospective, multi-centre, single arm, pilot clinical study to determine the accuracy of the ERLY SIGN Kit for early detection of Oral Cancer. - NI

CURO Biosciences Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•The inclusion criteria are as follows:
•Male or Female patients with age of eighteen (18) and above.
•Able to give informed consent.
•Patients meeting the inclusion criteria for one of the following study groups:
•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.
•Good oral hygiene.
•200 subjects with suspected Oral Carcinoma diagnosed with Premalignant oral lesions such as leukoplakia, erythroplakia, lichen planus, and submucous fibrosis.
•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

•The exclusion criteria are as follows:
•Patients who have participated in another investigational clinical study within thirty (30) days before screening.
•Inflammation, Cut or fissures in the oral cavity which was not preview of the Oral Cancer.
•Uncontrolled hypertension, diabetes mellitus or any other co-morbidity that is considered as an exclusion by the Investigator.
•Dementia or significantly altered mental status that would limit the ability to obtain informed consent and compliance with the requirements of this protocol.
•Patients with a history of cancer other than for selected group
•Significant medical history, immune-compromised and patients with COVID19 illness at present.
•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.
•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.
•Inability/lack of willingness to comply with visits, treatment plans, protocol assessments or laboratory tests.

发起方

CURO Biosciences Private Limited