Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06256809 |
| Other study ID # |
RGP1/347/44 |
| Secondary ID |
RGP1/347/44 |
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 29, 2024 |
| Est. completion date |
March 30, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
King Khalid University |
| Contact |
Sunil K Vaddamanu, MDS |
| Phone |
966 595220377 |
| Email |
snu[@]kku.edu.sa |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
The skin is the protective layer covering the entire human body which acts as a barrier
against various pathogens and also acts as a thermoregulatory organ. Skin is covered with
hair follicles and sebaceous glands except in the palmar aspect of hands and the plantar
aspect of soles. Both regions of the human body are devoid of hair and sebaceous glands but
these parts have increased nerve supply due to the presence of more sensory receptors.
A unique ridge pattern is present on the palmar aspect of hands and the plantar aspect of
soles called Epidermal Ridges (ER). These ridges are unique/different for every individual.
Primarily these ridges help in gripping the surface. After conception, this pattern starts to
develop from the 7th to 21st week of intra-gestation life. Creating a certain manner of sweat
gland pore arrangement around the Papilla (Conical eminence) leads to the formation of
epidermal ridges and is completed by 52 days of the gestation period.
Various factors influenced the development of these pattern formations which include genetic
and environmental factors. Abnormal configuration of dermal patterns is influenced by both
genetic and environmental factors causing disturbance during the intrauterine gestation
period of the fetus. One classic example of abnormal dermal patterns is associated with Down
syndrome where there will be an alteration in the Ridge pattern due to retardation affecting
the growth of different parts of bodies and ER.
The study of this variation of ER and fingertips of palm and sole is known as
"Dermatoglyphics".
In Greek, Derma means 'skin' and Glyphic means 'curved'. The initiation of Dermatoglyphic was
done by Sir Frank Galton and he classified it into three patterns: Loops, arches, and whorls.
Harold Clements conducted the first study on genetic abnormality with Dermatoglyphics
patterns in Down syndromes. The Father of dermatoglyphics is Cummins. J. CA Mayer in 1788
concludes in his study on fingerprint analysis that dermatoglyphics pattern cannot be
duplicated in two individuals. In 1858, Sir William Herschel (British Chief Administrator of
Officer in West Bengal) was the first to use dermatoglyphics for personal identification
which was used for criminology. Patterns of Dermatoglyphics can influence the genetic makeup
of an individual which can act as a guide for genetic diseases such as Down syndrome,
Klinefelter's syndrome, cancer, Alzheimer's, ovarian cancer, and schizophrenia.
Fingerprints are different in each individual; these are inherited and permanent to one
particular individual and do not repeat or change among parents, or siblings, not even in the
monozygotic twins. Unless in case of severe burns, cuts, and bruises due to this. The
preliminary feature of these fingerprints, they can be used as evidence for the
identification of a person in the forensic department and can be used as a tool in many
genetic abnormality studies.
Oral Leukoplakia (OL) and oral submucous fibrosis (OSF) are more common premalignant lesions
with high risk of malignant transformation rates of 0.6 to 20% and 1.5 to 15% respectively.
Both lesions are majorly caused due to tobacco usage in different forms and associated with
various features affecting oral mucosa like ulceration, xerostomia, burning sensation, and
alteration in collagen deposition. These pre-malignant lesions of the oral cavity commonly
lead to the formation of Oral squamous cell carcinoma (OSCC) due to alterations in the
function of genes.
Human genes regulate Cell signaling and tumor suppression which contributes to a decrease in
cancer cell production. The two main factors which influence most diseases are genetic and
epigenetic. Development of oral or head and neck squamous cell carcinoma (HNSCC) is
influenced by both these factors. Population-based studies to determine the genetic or
familial disposition to oral cancers are limited by coexisting risk factors like smoking and
alcohol. It is also believed that certain individuals inherit the susceptibility of inability
to metabolize carcinogens or procarcinogens and/or an impaired ability to repair DNA damage.
Oncogenes are altered growth-promoting regulatory genes that govern the cells' signal
transduction pathways, and mutation of these genes leads to either overproduction or
increased function of the excitatory proteins. Several oncogenes have been implicated in oral
carcinogenesis. Aberrant expression of the proto-oncogene epidermal growth factor receptor
(EGFR/c-erb 1), members of the ras gene family, c-myc, int-2, hst-1, PRAD-1, and bcl-1 is
believed to contribute towards cancer development. Hence the study of these genetic functions
and the abnormality of genes has a potential role in diagnosing the malignancy earlier.
However, this procedure required for the assessment of genes is expensive and complex.
Therefore assessing dermatoglyphics traits can be a simple, cost-effective, non-invasive
procedure along with clinical features for the early diagnosis of cancer, OSCC, and
pre-malignant lesions.
This study is conducted with the following objectives and aims:
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.
4. To assess the usefulness of this technique in acting as a predictor of oral squamous
cell carcinoma; the efficacy of this technique as a non-invasive diagnostic tool in the
identification of oral squamous cell carcinoma patients and also to identify persons at
risk of oral squamous cell carcinoma.
This study is assessed based on the following parameters: 1. Qualitative parameters: a.
Whorls b. Loops c. Arches 2. Quantitative parameters: a. Total finger ridge count (TFRC) b.
angle of the palm: at angles
