NCT04991610

Brief Summary

One of the most difficult areas of forensic science is identifying individuals. Accurate sex estimation based on measurements of dimorphic dimensions in unknown human remains is a crucial first step toward making individual identification. the most accurate approach to determine sex by bone size is based on os coxae or skull. After natural disaster their presence can never be guaranteed, therefore the development of methods of sex determination using other skeletal elements is crucial. The scapula is a paired short bone that will be researched in this study. The decision to focus on the scapula was made in the first place because of its minor morphological alterations after growing is complete. Second, short and flat bones appear to be better maintained than lengthy bones, which are frequently fractured, scattered, and mixed together. Scapular muscle attachments provide protection to the bone making it difficult to fracture or break . Comparative studies on different populations have shown population-specific results in the discriminant function equations for sex estimation. There is significant population variation due to sexual dimorphism in the growth rate and developmental process of human beings. Genetics play an important role in this variation. Nevertheless, environmental factors, nutrition, secular changes and diseases also play an important role in sexual dimorphism .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 5, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

August 5, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

July 25, 2021

Last Update Submit

August 4, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Maximum scapular length

    the parameter measured The length between the highest point of superior angle and lowest point of inferior angle via software program . All CT scans will be obtained from patients lying in a supine position using 120 kV tube voltage, 150 effective mA and 1 mm slice thickness parameters.

    12 Months

  • Scapular breadth

    the parameter measured from the middle of the dorsal border of glenoid fossa to the end of spinal axis on the vertebral border. via software program All CT scans will be obtained from patients lying in a supine position using 120 kV tube voltage, 150 effective mA and 1 mm slice thickness parameters.

    12 Months

  • Maximum length of spine

    the parameter measured From the medial border of the scapula at the spinous axis to the most lateral point on the scapular spine via software program . All CT scans will be obtained from patients lying in a supine position using 120 kV tube voltage, 150 effective mA and 1 mm slice thickness parameters.

    12 Months

Study Arms (2)

Adult male

ACTIVE COMPARATOR

CT scans will be obtained from patients lying in a supine position using 120 kV tube voltage, 150 effective mA and 1 mm slice thickness parameters.

Radiation: computed tomography

Adult female

ACTIVE COMPARATOR

CT scans will be obtained from patients lying in a supine position using 120 kV tube voltage, 150 effective mA and 1 mm slice thickness parameters.

Radiation: computed tomography

Interventions

CT scans will be obtained from patients lying in a supine position using 120 kV tube voltage, 150 effective mA and 1 mm slice thickness parameters.

Adult femaleAdult male

Eligibility Criteria

Age25 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailsshoud be above 25 years and be healthy.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • persons above 25 years old

You may not qualify if:

  • Cases below 25 years
  • scapular, vertebral fractures
  • growth disorders
  • severe osteoporosis
  • tumor
  • arthritis
  • previous orthopedic surgery
  • infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university

Sohag, Egypt

RECRUITING

Related Publications (3)

  • O'Bright L, Peckmann TR, Meek S. Is "Latin American" population-specific? Testing sex discriminant functions from the Mexican tibia on a Chilean sample. Forensic Sci Int. 2018 Jun;287:223.e1-223.e7. doi: 10.1016/j.forsciint.2018.03.046. Epub 2018 Apr 4.

    PMID: 29692330BACKGROUND
  • Ubelaker DH, DeGaglia CM. Population variation in skeletal sexual dimorphism. Forensic Sci Int. 2017 Sep;278:407.e1-407.e7. doi: 10.1016/j.forsciint.2017.06.012. Epub 2017 Jun 19.

    PMID: 28698063BACKGROUND
  • Papaioannou VA, Kranioti EF, Joveneaux P, Nathena D, Michalodimitrakis M. Corrigendum to "Sexual dimorphism of the scapula and the clavicle in a contemporary Greek population: Applications in forensic identification" [Forensic Sci. Int. 217 (2012) 231.e1-231.e7]. Forensic Sci Int. 2017 Jan;270:183. doi: 10.1016/j.forsciint.2016.12.012. Epub 2016 Dec 16. No abstract available.

    PMID: 27992821BACKGROUND

MeSH Terms

Conditions

Sexism

Condition Hierarchy (Ancestors)

PrejudiceSocial BehaviorBehaviorSocial Discrimination

Study Officials

  • maha A Helal, professor

    faculty of medicine sohag university

    STUDY DIRECTOR

Central Study Contacts

Dalia M Khalaf, demonstrator

CONTACT

Maha A Helal, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: All measurements will be made by scanning of patients who coming to radiology department at sohag university hospital known of their birth date and sex who underwent thoracic CT scan evaluation during a pulmonary screening program . a descriptive comparative study will be conducted on total population of 100 sohag subjects (50 adult males and 50 adult females) from 25 years and above , using CT scan images to estimate the above mentioned diameters..
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assistant, Department of Forensic Medicine and Toxicology

Study Record Dates

First Submitted

July 25, 2021

First Posted

August 5, 2021

Study Start

July 1, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

August 5, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

The present study aims to investigate sexual dimorphism of the scapula and establish metric standards and databases for sex estimation in a Sohag population sample

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
in july 2023
Access Criteria
Data will be gathered and analyzed using the mean, mode, and standard deviation by using SPSS program to compare mean differences between the sexes. The statistical difference will be done to compare two groups of parametric data by student - t-test .

Locations