Sex DiscriminationNCT04991610
Sex Determination From Scapula Using 3-D Computed Tomography in Sample of Sohag Governorate Population
A study testing computed tomography in people with Sex Discrimination, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sex Discrimination
- What is being tested?
- computed tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- persons above 25 years old
Who cannot join
- Cases below 25 years
- scapular, vertebral fractures
- growth disorders
- severe osteoporosis
- tumor
- arthritis
- previous orthopedic surgery
- infection
Trial locations and contacts
1 site in 1 country.
Maha A Helal, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university
Sohag
Osama R Elsherief, Professor, portal@med.sohag.edu.eg
About this study
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.
Read more
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 .
Read the detailed description
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. 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. The first study that used the scapula in sex estimation was conducted by Dwight in 1894.
Dwight measured the height of the glenoid fossae and maximum scapular length of 123 patients (84 males and 39 females),Dwight's method showed that the scapular height had a high predictive value.
In 2010, Dabbs and Moore-Jansen applied the 23 parameter method to 803 individuals of the Hamann-Todd collection in their study and showed that the overall accuracy of this method was 95.7%.
studies reveal that the use of Computed tomography (CT) images increases accuracy and reproducibility over traditional methods in establishing a biological profile .
even though there is evidence of sexual dimorphism in the scapula according to several published studies, the validity of scapula for sex estimation has not been explored in depth in modern population where a general lack of contemporary osteometric databases noted.
in this paper , this study is presented in order to test the efficacy of scapula to serve as sex indicator for forensic purposes.
- Conditions
- Sex Discrimination
- Being tested
- computed tomography
- Medical subject headings
- Sexism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed tomographyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Radiation: computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Jul 2021
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sex DiscriminationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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..
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daila Mohamed Khalaf, Sohag University
- Investigators
- maha A Helal, professor, Study director, faculty of medicine sohag university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991610
- Sponsor's protocol ID
- Soh-Med-21-07-15
- Status last verified
- Aug 2021
- First submitted
- 25 Jul 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 29692330Ubelaker 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.
PubMed 28698063Papaioannou 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.
PubMed 27992821
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Determination From Scapula Using 3-D Computed Tomography in Sample of Sohag Governorate Population
- ClinicalTrials.gov ID
- NCT04991610
- Acronym / sponsor ID
- Soh-Med-21-07-15
- Conditions
- Sex Discrimination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
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. 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. The first study that used the scapula in sex estimation was conducted by Dwight in 1894.
Dwight measured the height of the glenoid fossae and maximum scapular length of 123 patients (84 males and 39 females),Dwight's method showed that the scapular height had a high predictive value.
In 2010, Dabbs and Moore-Jansen applied the 23 parameter method to 803 individuals of the Hamann-Todd collection in their study and showed that the overall accuracy of this method was 95.7%.
studies reveal that the use of Computed tomography (CT) images increases accuracy and reproducibility over traditional methods in establishing a biological profile .
even though there is evidence of sexual dimorphism in the scapula according to several published studies, the validity of scapula for sex estimation has not been explored in depth in modern population where a general lack of contemporary osteometric databases noted.
in this paper , this study is presented in order to test the efficacy of scapula to serve as sex indicator for forensic purposes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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..
| Arm | Type | Receives |
|---|---|---|
| Adult male | Active comparator | Radiation: computed tomographyCT 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 female | Active comparator | Radiation: computed tomographyCT 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- persons above 25 years old
Key exclusion criteria (8 listed)
- Cases below 25 years
- scapular, vertebral fractures
- growth disorders
- severe osteoporosis
- tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computed tomographyCT 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 | Adult female, Adult male |
Primary outcome
Maximum scapular length
Time frame: 12 Months
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.
Scapular breadth
Time frame: 12 Months
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.
Maximum length of spine
Time frame: 12 Months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Background: PubMed 29692330O'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.
- Background: PubMed 28698063Ubelaker 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.
- Background: PubMed 27992821Papaioannou 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.
- Individual participant dataSharing planned: Yes. 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
Related trials for Sex Discrimination
RecruitingObservational study
Ethnic and Gender Based Admittance Patterns in the ICU
Critical Illness, Gender Equality
Not yet recruiting
A Virtual Reality Couples' Intervention for Sexual Victimization Prevention: a Gender-swapping Transformative Approach
Sexual Harassment, Gender Based Violence
Active, not recruiting
Peer Counselling to Reduce Psychological Distress and Exposure to Violence Among Sexual and Gender Minorities
Mental Health, Psychological Distress
RecruitingObservational study
Valvular Heart Disease in Women Registry
Valve Disease, Heart, Gender Bias
RecruitingObservational study
Evaluation of the Effect of the BOAT® Structured Prevention Program on Violence in Middle Schools
Students, Middle Schools
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maha A Helal, Professor contact
maha A Helal, professor study director
faculty of medicine sohag university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computed tomography in people with Sex Discrimination, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalia M Khalaf, demonstrator (01050116734, dalia011081@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum scapular length (time frame: 12 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04991610, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.