Usefulness of newly developed light emitting device for screening of precancer and cancer

Not yet recruiting

Conditions: Granuloma and granuloma-like lesions of oral mucosa, (2) ICD-10 Condition: K132||Leukoplakia and other disturbancesof oral epithelium, including tongue, (3) ICD-10 Condition: K135||Oral submucous fibrosis, (4) ICD-10 Condition: K137||Other and unspecified lesions of oral mucosa,

Registration Number: CTRI/2020/01/022999

Lead Sponsor: Keerthilatha M Pai

Brief Summary: Oral cancer is an emergingepidemic which is amenable for screening with minimal resource. It is the thirdmost common cancer affecting Indian males. Early detection of oral cancer can improve the five year survival rate,reduce the morbidity associated with treatment and also prevent recurrence to10â€“20%. Oral cancer is often preceded by dysplastic oral mucosal conditionswhich have potential for malignant transformation. Conventionally, the diagnosis is done by histopathologicevaluation of biopsy specimen which is invasive and causes severe patientdiscomfort. Hence it cannot be done as a routine screening test and is advisedonly when there is a strong clinical suspicion of malignant transformation. Non-invasivescreening modalities for early identification of the cancer and oral dysplasticconditions are the need of the hour. Novellight emitting device under study is a non -invasive, user friendly, low costdevice which aims to guide the clinicians in assessing the early dysplasticoral mucosal areas. If tested useful and effective, this device can be a usefuladjunct in screening the general population, especially the high risk category,on a regular basis. As it is non-invasive, it is more patient compliant and canbe helpful in patient education as well. The present study intends to test thereliability and validity of a novelnon-invasive screening tool for oral cancer.

Subjectswill be screened in the department of oral medicine and radiology and eligibleparticipants would be enrolled into the trial. Only conditions which havebiopsy as a standard of care would be recruited in the study and control group.After the consent, the participant would be evaluated with the help of novellight emitting device and pictures of the oral cavity would be captured underUV, white light and narrow band light of the various areas of interest. Thiswould be followed by biopsy and suture placement. A brief history whichincluded age, gender, patients habits if any, frequency and duration, andsymptoms will also be recorded. Based on the biopsy report, patients will becounseled by the clinicians as and when required for further modalities oftreatment.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

Potential malignant oral disorders and oral cancer group: Patients with potential malignant oral disorders and oral cancer Controls: Patients other than potential malignant oral disorders and oral cancer requiring any type of biopsy in the oral cavity.

Exclusion Criteria

Exclusion Criteria: Subjects with minimal comprehension, not willing for biopsy, any medical condition that contraindicates the use of biopsy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reliability and validity of the light emitting device in comparison to biopsy	1 week

Secondary Outcome Measures

Name	Time	Method
sensitivity, specificity, negative and positive predictive values	1 week

Trial Locations

Locations (1): Manipal College of Dental Sciences, Manipal
🇮🇳
Udupi, KARNATAKA, India
Manipal College of Dental Sciences, Manipal
🇮🇳Udupi, KARNATAKA, India
Keerthilatha M Pai
Principal investigator
9845637938
keerthilatha.pai@manipal.edu