Ignite Creation Date:
2024-07-17 @ 11:09 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471270
Status:
COMPLETED
Last Update Posted:
2024-06-24
First Post:
2024-06-14
Brief Title:
Validation of Salivary Proteomic Biomarkers for Early Detection of Oral Cancer in Egyptian Population
Sponsor:
British University In Egypt
Organization:
British University In Egypt
Study Overview
Official Title:
Validation of Salivary Proteomic Biomarkers for Early Detection of Oral Cancer in Egyptian Population
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present investigation was conducted on 100 individuals allocated into four groups 25 healthy controls 25 patients having OPMDs with dysplasia 25 patients having OPMDs without dysplasia and 25 oral cancer patients Demographic data including data related to different risk factors modified gingival index oral hygiene level in addition to salivary levels of IL-6 IL-8 and sCD44 were assessed
Detailed Description:
Histopathologic evaluation
Biopsy samples were obtained from all lesions to verify the diagnosis and establish the presence of dysplasia in the potentially premalignant lesions before allocating patients to their specific groups
History and clinical assessment
Demographic data as age and gender medical history and habits as smoking and alcohol were obtained during patient interview Modified gingival index MGI level of oral hygiene OH and the number of remaining natural teeth were also assessed Subjects not willing to sign a written informed consent pregnant females lactating mothers and patients with immunosuppressive disorders were excluded
Modified gingival index MGI evaluates the presence and degree of gingival inflammation A score of 0 means absence of inflammation 1 indicates mild inflammation slight redness of any part of the gingiva 2- mild inflammation of the whole gingiva 3- moderate inflammation moderate redness edema andor hypertrophy of the gingiva 4-severe inflammation marked redness and spontaneous bleeding of the gingiva Level of OH care was evaluated corresponding to the OH habits of the patient and efficiency of plaque removal OH level is scored as 1- very good 2- good 3- fair and 4- poor OH
Collection of 10-20 mL of whole unstimulated saliva was obtained between nine and twelve in the morning to evade diurnal alteration Participants refrained from eating smoking brushing and mouthwash use 2 hours before to salivary sampling which were stored at -70 C till analyzed
Quantification of salivary IL-6 IL-8 and sCD44 in all samples using an ELISA kit
List of abbreviations
OSCC Oral squamous cell carcinoma OPMDs Oral potentially malignant disorders HNSCC Head and neck squamous cell carcinoma MGI Modified gingival index OH Level of oral hygiene ROC Receiver operating characteristic
Biopsy samples were obtained from all lesions to verify the diagnosis and establish the presence of dysplasia in the potentially premalignant lesions before allocating patients to their specific groups
History and clinical assessment
Demographic data as age and gender medical history and habits as smoking and alcohol were obtained during patient interview Modified gingival index MGI level of oral hygiene OH and the number of remaining natural teeth were also assessed Subjects not willing to sign a written informed consent pregnant females lactating mothers and patients with immunosuppressive disorders were excluded
Modified gingival index MGI evaluates the presence and degree of gingival inflammation A score of 0 means absence of inflammation 1 indicates mild inflammation slight redness of any part of the gingiva 2- mild inflammation of the whole gingiva 3- moderate inflammation moderate redness edema andor hypertrophy of the gingiva 4-severe inflammation marked redness and spontaneous bleeding of the gingiva Level of OH care was evaluated corresponding to the OH habits of the patient and efficiency of plaque removal OH level is scored as 1- very good 2- good 3- fair and 4- poor OH
Collection of 10-20 mL of whole unstimulated saliva was obtained between nine and twelve in the morning to evade diurnal alteration Participants refrained from eating smoking brushing and mouthwash use 2 hours before to salivary sampling which were stored at -70 C till analyzed
Quantification of salivary IL-6 IL-8 and sCD44 in all samples using an ELISA kit
List of abbreviations
OSCC Oral squamous cell carcinoma OPMDs Oral potentially malignant disorders HNSCC Head and neck squamous cell carcinoma MGI Modified gingival index OH Level of oral hygiene ROC Receiver operating characteristic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None