Health Condition 1: D000- Carcinoma in situ of lip, oral cavity and pharynx Health Condition 2: C000- Malignant neoplasm of external upper lip Health Condition 3: C001- Malignant neoplasm of external lower lip Health Condition 4: C002- Malignant neoplasm of external lip, unspecified Health Condition 5: C003- Malignant neoplasm of upper lip, inner aspect Health Condition 6: C004- Malignant neoplasm of lower lip, inner aspect Health Condition 7: C005- Malignant neoplasm of lip, unspecified, inner
Conditions
Interventions
Intervention1: ERLY SIGN Kit: ERLY SIGN kit is based on Gelatinase activity and designed for detection of proteolytic activity of a biological sample preferably a body fluid like saliva collected and
Sponsors
CURO Biosciences Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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: 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. ? 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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)Timepoint: 1 day | — |
Secondary
| Measure | Time frame |
|---|---|
| ?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 ?To establish a correlation between the medical history and habits of oral cancer patients with the active levels of MMP-2 and/or MMP-9 as determined by the proposed kit.Timepoint: 90 days | — |
Countries
India
Contacts
Public ContactDr Deovrat Begde
CURO Biosciences Private Limited
Outcome results
None listed