Health Condition 1: R888- Abnormal findings in other body fluids and substances Health Condition 2: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Sponsors
MedGenome Labs ltd
Eligibility
Inclusion criteria
Inclusion criteria: An eligible patient must satisfy all of the following criteria for inclusion. Must be 18 years or older. Has been diagnosed with a cancer of the oral cavity by screening or clinical presentation. Has been scheduled to undergo biopsy or surgical resection for a known or highly suspected malignancy in the oral cavity. Shows no signs of metastasis. Eligibility criteria for At-Risk Individuals with leukoplakia erythroplakia submucosal fibrosis oral lichen planus. An eligible patient must satisfy all of the following criteria for inclusion. Must be between 18 and 65 years. Has been diagnosed with suspected OPMDs by screening or clinical presentation. Agrees to report any changes in medical condition. Agrees to be followed up by telephonic conversation, once every six months, for up to two years Eligibility criteria for Apparent-Normal Individuals i.e. without any cancerous condition An Apparent Normal volunteer must satisfy all of the following criteria for inclusion. Must be between 18 and 65 years. Does not present any symptoms of a cancer in the oral cavity or elsewhere. Does not have a serious medical history or a past oral surgery. Does not have a history of cancer in the immediate family. Agrees to report any changes in medical condition. Agrees to be followed up by telephonic conversation once every six months for up to two years.
Exclusion criteria
Exclusion criteria: Exclusion criteria for All cancer patients At risk and Apparent Normal Individuals The individual is not eligible to be included in the study if he or she Is unable to understand or willing to sign an institutional review board approved written informed consent document before any study specific procedures. Is unwilling to comply with all study procedures. Has any cancer other than OSCC or dysplasia in the oral cavity. Has previously undergone an oral surgery in the past. Has previously undergone a definitive local therapy or an extensive surgery. Is currently undergoing or has received any chemotherapy radiotherapy or immunotherapy in the past. Has fever or shows symptoms of a fever on the day of liquid biopsy Is a recipient of an organ transplant or allogenic bone marrow or stem cell transplant in the past Has undergone a blood transfusion in the last 30 days Has been treated with corticosteroids in the last 30 days Has a current or past pregnancy in the last 30 days. Has a condition that, in the opinion of the clinician, would interfere with successful evaluation and interpretation of the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the epigenetic and proteomic alterations in participants with OCC and identify potential biomarkersTimepoint: subjects Follow up will be done for every once in 6 months for 2 years for all the arm | — |
Secondary
| Measure | Time frame |
|---|---|
| Development of non-invasive diagnostic products for early detection of OCC and OPMD with high sensitivity and specificityTimepoint: visit for every 6 months once for 2 years | — |
Countries
India
Contacts
Public ContactDr S Mythili
Sri Ramachandra Institute Of Higher Education and Research
Outcome results
None listed