Analyzing Handprint Patterns to Predict Oral Cancer Risks: A Comparative Study

NCT06256809 | Not Yet Recruiting

• 1 other identifier: RGP1/347/44
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aims: To evaluate the qualitative and quantitative parameters of finger and palmar dermatoglyphic patterns in patients with oral premalignant and malignant lesions OBJECTIVES: 1. To record and study the palmar and fingerprint patterns in patients with oral premalignant and malignant lesions 2. To assess the variations in patterns of dermatoglyphic features between cases and controls and to observe the significant result. 3\. To evaluate which dermatoglyphic pattern is predominant among patients with premalignant and malignant lesions. Materials and METHODS: Fingerprints and palm prints were studied in 160 patients, who were randomly divided into four groups: A. 40 patients with a history of areca nut /tobacco intake with the occurrence of the premalignant lesion (B) 40 patients with a history of areca nut /tobacco intake with the occurrence of Oral Squamous Cell Carcinoma. (C) As healthy controls, 40 patients with tobacco/areca nut chewing habits, without any evidence of oral lesions (D) 40 patients without any habit, and without any oral lesions. Dermatoglyphic patterns were recorded and analyzed in the four groups using the standard ink method.

Conditions

Oral Leukoplakia

Outcome Measures

Primary Outcomes (2)

• Prevalence of Dermatoglyphic Pattern Types in Oral Lesion Patients

  This measure will assess and document the prevalence of whorls, loops, and arches separately in the patient group, allowing for a direct comparison with the control group.and quantitative parameters (Total Finger Ridge Count (TFRC), atd angles) in patients with diagnosed oral premalignant (OL, OSF) and malignant lesions (OSCC). The primary outcome will evaluate the prevalence and characteristics of these patterns in the patient group compared to the control group.

  6-12 months

• Quantitative Dermatoglyphic Parameters in Oral Lesion Patients

  This measure will document the average TFRC and atd angles for the patient group, facilitating a comparison with average values from the control group to identify significant differences.

  6-12 months.

Secondary Outcomes (1)

• Correlation between Dermatoglyphic Patterns and Severity of Oral Lesions

  6-12 months

Study Arms (2)

Oral Lesion Risk Assessment Group

This group comprises individuals undergoing evaluation for dermatoglyphic patterns indicative of a predisposition to oral premalignant and malignant lesions. The group includes two sub-cohorts: one consisting of patients with diagnosed oral conditions like Oral Leukoplakia (OL), Oral Submucous Fibrosis (OSF), and Oral Squamous Cell Carcinoma (OSCC), and a control sub-cohort of individuals without these conditions. Dermatoglyphic analysis, including qualitative (whorls, loops, arches) and quantitative (Total Finger Ridge Count (TFRC), atd angles) parameters, will be conducted to assess potential predictive patterns and their correlation with oral lesion risks. No direct interventions are involved; the study focuses on observation and pattern analysis for potential early diagnosis and risk assessment.

Healthy Control Group

This group consists of individuals with no history or diagnosis of oral premalignant or malignant lesions. They serve as a baseline comparison to the "Oral Lesion Risk Assessment Group". The dermatoglyphic patterns (whorls, loops, arches) and quantitative parameters (Total Finger Ridge Count (TFRC), atd angles) of this group are analyzed and compared with those of the patient group to identify distinctive patterns or traits associated with oral health conditions. This comparison aims to enhance the understanding of dermatoglyphic variations and their potential role in predicting oral health risks. No interventions are involved; the group is purely observational for comparative analysis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population for this type of research typically consists of individuals diagnosed with oral premalignant conditions like Oral Leukoplakia or Oral Submucous Fibrosis, and those with malignant lesions such as Oral Squamous Cell Carcinoma. A control group of individuals without these conditions is also included for comparison. The study aims to analyze and compare the dermatoglyphic patterns (fingerprints and palm prints) of these groups to explore potential indicators or predictors of oral health conditions.

You may qualify if:

• Individuals diagnosed with specific oral conditions such as Oral Leukoplakia, Oral Submucous Fibrosis, or Oral Squamous Cell Carcinoma.
• Individuals willing to participate in the study.

You may not qualify if:

• Individuals with systemic diseases that could affect dermatoglyphic patterns.
• Individuals who have undergone treatments that could alter palmar or plantar patterns.

Sponsors & Collaborators

• King Khalid University: lead

MeSH Terms

Conditions

Leukoplakia, Oral

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Leukoplakia; Precancerous Conditions; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sunil K Vaddamanu, MDS

CONTACT

966 595220377; snu@kku.edu.sa

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 13, 2024
• Study Start: February 29, 2024
• Primary Completion: March 15, 2024
• Study Completion: March 30, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF