AdolescenceAGE-ADONCT01577498
Age Estimation of Adolescents for Legal Purposes
An observational study of Adolescence and Bone Maturation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Economic globalisation has been associated with a rise of cross-border migration in Europe. In France, courts commonly demand appropriate medical tests aimed at age estimations of supposed minors without documentation. Read more about this study
- Who is it for?
- Ages 10 to 30 years, men only
- Conditions the study is for
- Adolescence, Bone Maturation
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- May 2012to Mar 2014
- Phase
- Observational
- 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 10 to 30 years
- Men only
- No healthy volunteers
- Child, Adult
Study population: Adolescents or young adult addressed by the judicial police officer,for age determination in one of the participating centers
Who may be able to join
- Adolescent or young adult referred by judicial authorities for age determination
Who cannot join
- Refusal to undergo a medical examination
Trial locations and contacts
1 site in 1 country.
France1 site
: Jean Verdier hospital, Department of forensic medicine
Bondy, 93140
About this study
Official title: Age Estimation of Adolescents for Legal Purposes: Determining the Medical Response
Economic globalisation has been associated with a rise of cross-border migration in Europe. In France, courts commonly demand appropriate medical tests aimed at age estimations of supposed minors without documentation. Determining the age of foreign adolescents may be important in order to define the rights and protection afforded them by law depending on this status, and the conditions in which they may be detained or held in police custody if they are under suspicion. Age estimation is considered to be ideally based on the combination of clinical, skeletal, and dental examinations. A number of forensic physicians do not integrate published recommendations or the results of published studies into their daily practice. Previous studies have shown that medical practice is heterogeneous in this area. Factors determining this heterogeneity are unknown.
We hypothesize that the personal and professional development of the physician, as well as the characteristics and the circumstances of medical examination can affect medical response on age determination, beyond clinical and radiological data. The purpose of this study is to identify factors determining medical response to courts.
Read the detailed description
Economic globalisation has been associated with a rise of cross-border migration in Europe. Courts commonly demand appropriate medical tests aimed at age estimations of supposed minors without documentation. Determining the age of foreign adolescents may be important in order to define the rights and protection afforded them by law depending on this status, and the conditions in which they may be detained or held in police custody if they are under suspicion.
Guidelines for age estimation in living individuals have been proposed and are based on the combination of general clinical, skeletal, and dental examinations. However, guidelines for paediatricians in the UK and a national consensus conference in France on doctors' attendance on detainees in police custody have stated that the currently available methods generally do not enable a doctor to state with confidence if a detainee is a minor or not. The validity of currently used methods has also been questioned by the French National Consultative Ethics Committee on Health and Life Sciences.
As any middle school teacher can testify, anthropometric measures such as height and weight, and visible signs of sexual maturity vary widely from one adolescent to another, so that general clinical examination has limited value for age estimation. The skeletal examination is considered more reliable. In the reference radiological method, X-ray examination of the left hand and wrist is compared with standard images from an atlas published by Greulich and Pyle, who collected standards obtained in the 1930's and 1940's from an American white middle-class population. The main criteria applied for dental age determination are the eruption and development of the third molars, based on external and X-ray examination.
Age estimation is considered to be ideally based on the combination of clinical, skeletal, and dental examinations. However, it is not easy to determine from available published series if the estimated age of a given individual is a precise age or a spectrum of possible ages, and in this case how broad is the proposed spectrum. Indeed, the information in the radiological atlas by Greulich and Pyle is statistical, not individual. The use of such data for forensic purposes has never been intended by the authors, nor validated. Moreover, the ethnic and socioeconomic characteristics of the adolescents examined today in Western Europe may differ largely from those presented in the atlas, as previously suggested. The role of ethnic factors in skeletal maturation has been repeatedly studied and gave conflicting results. In most series evaluating skeletal age in different populations, hand and wrist X-rays were obtained from healthy subjects or patients received for evaluation of trauma. The conclusions of these studies may not be validated, or at least should be considered cautiously, when extrapolating results to adolescents without documents involved in judicial procedures, who have heterogeneous and largely unevaluated psychological and socioeconomic characteristics. A number of forensic physicians do not integrate published recommendations or the results of published studies into their daily practice. Previous studies have shown that medical practice is heterogeneous in this area. Factors determining this heterogeneity are unknown.
We hypothesize that the personal and professional development of the physician, as well as the characteristics and the circumstances of medical examination can affect medical response on age determination, beyond clinical and radiological data. The main objective of this study is to identify factors determining medical response to courts. A secondary objective is to evaluate how evidence-based data obtained from medical journals are taken into account in medical decision making by forensic physicians.
The main evaluated criterium is the medical response transmitted to courts regarding age determination.
Methods Prospective observational study of 500 age determinations requested by courts in migrant adolescents without documentation, in 18 departments of forensic medicine in France. Non-inclusion criterium is the refusal of the adolescent to undergo a medical examination.
- Conditions
- Adolescence, Bone Maturation
- Keywords
- Skeletal age, Chronological age, Adolescent
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical response transmitted to courts regarding age determination, at the end of medical examination
Measured: One hour
Secondary outcomes (1)
Age evaluation based on published evidence on age determination, as evaluated by independent experts at 12 months
In each case, compatibility of (1) age (or age interval) transmitted to courts and (2) age evaluation based on published evidence on age determination, as evaluated by independent experts.
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 posted13 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionApr 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AdolescenceStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PATRICK CHARIOT, MD, Principal investigator, AP-HP Hospital Jean Verdier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577498
- Sponsor's protocol ID
- AOR 11118
- Acronym
- AGE-ADO
- Status last verified
- May 2016
- First submitted
- 30 Mar 2012
- Last updated
- 10 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pruvost MO, Boraud C, Chariot P. Skeletal age determination in adolescents involved in judicial procedures: from evidence-based principles to medical practice. J Med Ethics. 2010 Feb;36(2):71-4. doi: 10.1136/jme.2009.031948.
PubMed 20133398Buken B, Safak AA, Yazici B, Buken E, Mayda AS. Is the assessment of bone age by the Greulich-Pyle method reliable at forensic age estimation for Turkish children? Forensic Sci Int. 2007 Dec 20;173(2-3):146-53. doi: 10.1016/j.forsciint.2007.02.023. Epub 2007 Mar 27.
PubMed 17391883Schmeling A, Olze A, Reisinger W, Geserick G. Age estimation of living people undergoing criminal proceedings. Lancet. 2001 Jul 14;358(9276):89-90. doi: 10.1016/S0140-6736(01)05379-X. No abstract available.
PubMed 11463408Garamendi PM, Landa MI, Ballesteros J, Solano MA. Reliability of the methods applied to assess age minority in living subjects around 18 years old. A survey on a Moroccan origin population. Forensic Sci Int. 2005 Nov 10;154(1):3-12. doi: 10.1016/j.forsciint.2004.08.018. Epub 2004 Nov 10.
PubMed 16182943Hassanali J. The third permanent molar eruption in Kenyan Africans and Asians. Ann Hum Biol. 1985 Nov-Dec;12(6):517-23. doi: 10.1080/03014468500008091.
PubMed 4091506
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age Estimation of Adolescents for Legal Purposes: Determining the Medical Response
- ClinicalTrials.gov ID
- NCT01577498
- Acronym / sponsor ID
- AGE-ADO / AOR 11118
- Conditions
- Adolescence, Bone Maturation
- Keywords
- Skeletal age, Chronological age, Adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 13 Apr 2012 (estimated)
- 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.
Economic globalisation has been associated with a rise of cross-border migration in Europe. In France, courts commonly demand appropriate medical tests aimed at age estimations of supposed minors without documentation. Determining the age of foreign adolescents may be important in order to define the rights and protection afforded them by law depending on this status, and the conditions in which they may be detained or held in police custody if they are under suspicion. Age estimation is considered to be ideally based on the combination of clinical, skeletal, and dental examinations. A number of forensic physicians do not integrate published recommendations or the results of published studies into their daily practice. Previous studies have shown that medical practice is heterogeneous in this area. Factors determining this heterogeneity are unknown.
We hypothesize that the personal and professional development of the physician, as well as the characteristics and the circumstances of medical examination can affect medical response on age determination, beyond clinical and radiological data. The purpose of this study is to identify factors determining medical response to courts.
Detailed description
Economic globalisation has been associated with a rise of cross-border migration in Europe. Courts commonly demand appropriate medical tests aimed at age estimations of supposed minors without documentation. Determining the age of foreign adolescents may be important in order to define the rights and protection afforded them by law depending on this status, and the conditions in which they may be detained or held in police custody if they are under suspicion.
Guidelines for age estimation in living individuals have been proposed and are based on the combination of general clinical, skeletal, and dental examinations. However, guidelines for paediatricians in the UK and a national consensus conference in France on doctors' attendance on detainees in police custody have stated that the currently available methods generally do not enable a doctor to state with confidence if a detainee is a minor or not. The validity of currently used methods has also been questioned by the French National Consultative Ethics Committee on Health and Life Sciences.
As any middle school teacher can testify, anthropometric measures such as height and weight, and visible signs of sexual maturity vary widely from one adolescent to another, so that general clinical examination has limited value for age estimation. The skeletal examination is considered more reliable. In the reference radiological method, X-ray examination of the left hand and wrist is compared with standard images from an atlas published by Greulich and Pyle, who collected standards obtained in the 1930's and 1940's from an American white middle-class population. The main criteria applied for dental age determination are the eruption and development of the third molars, based on external and X-ray examination.
Age estimation is considered to be ideally based on the combination of clinical, skeletal, and dental examinations. However, it is not easy to determine from available published series if the estimated age of a given individual is a precise age or a spectrum of possible ages, and in this case how broad is the proposed spectrum. Indeed, the information in the radiological atlas by Greulich and Pyle is statistical, not individual. The use of such data for forensic purposes has never been intended by the authors, nor validated. Moreover, the ethnic and socioeconomic characteristics of the adolescents examined today in Western Europe may differ largely from those presented in the atlas, as previously suggested. The role of ethnic factors in skeletal maturation has been repeatedly studied and gave conflicting results. In most series evaluating skeletal age in different populations, hand and wrist X-rays were obtained from healthy subjects or patients received for evaluation of trauma. The conclusions of these studies may not be validated, or at least should be considered cautiously, when extrapolating results to adolescents without documents involved in judicial procedures, who have heterogeneous and largely unevaluated psychological and socioeconomic characteristics. A number of forensic physicians do not integrate published recommendations or the results of published studies into their daily practice. Previous studies have shown that medical practice is heterogeneous in this area. Factors determining this heterogeneity are unknown.
We hypothesize that the personal and professional development of the physician, as well as the characteristics and the circumstances of medical examination can affect medical response on age determination, beyond clinical and radiological data. The main objective of this study is to identify factors determining medical response to courts. A secondary objective is to evaluate how evidence-based data obtained from medical journals are taken into account in medical decision making by forensic physicians.
The main evaluated criterium is the medical response transmitted to courts regarding age determination.
Methods Prospective observational study of 500 age determinations requested by courts in migrant adolescents without documentation, in 18 departments of forensic medicine in France. Non-inclusion criterium is the refusal of the adolescent to undergo a medical examination.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents or young adult addressed by the judicial police officer,for age determination in one of the participating centers
Key inclusion criteria (1 listed)
- Adolescent or young adult referred by judicial authorities for age determination
Key exclusion criteria (1 listed)
- Refusal to undergo a medical examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Medical response transmitted to courts regarding age determination, at the end of medical examination
Time frame: One hour
1 secondary outcome
Age evaluation based on published evidence on age determination, as evaluated by independent experts at 12 months
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.
- Background: PubMed 20133398Pruvost MO, Boraud C, Chariot P. Skeletal age determination in adolescents involved in judicial procedures: from evidence-based principles to medical practice. J Med Ethics. 2010 Feb;36(2):71-4. doi: 10.1136/jme.2009.031948.
- Background: PubMed 17391883Buken B, Safak AA, Yazici B, Buken E, Mayda AS. Is the assessment of bone age by the Greulich-Pyle method reliable at forensic age estimation for Turkish children? Forensic Sci Int. 2007 Dec 20;173(2-3):146-53. doi: 10.1016/j.forsciint.2007.02.023. Epub 2007 Mar 27.
- Background: PubMed 11463408Schmeling A, Olze A, Reisinger W, Geserick G. Age estimation of living people undergoing criminal proceedings. Lancet. 2001 Jul 14;358(9276):89-90. doi: 10.1016/S0140-6736(01)05379-X. No abstract available.
- Background: PubMed 16182943Garamendi PM, Landa MI, Ballesteros J, Solano MA. Reliability of the methods applied to assess age minority in living subjects around 18 years old. A survey on a Moroccan origin population. Forensic Sci Int. 2005 Nov 10;154(1):3-12. doi: 10.1016/j.forsciint.2004.08.018. Epub 2004 Nov 10.
- Background: PubMed 4091506Hassanali J. The third permanent molar eruption in Kenyan Africans and Asians. Ann Hum Biol. 1985 Nov-Dec;12(6):517-23. doi: 10.1080/03014468500008091.
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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.
PATRICK CHARIOT, MD principal investigator
AP-HP Hospital Jean Verdier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescence and Bone Maturation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 1 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: finished, as of the sponsor's last update on 10 Jun 2016. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical response transmitted to courts regarding age determination, at the end of medical examination (time frame: One hour). 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 NCT01577498, which also lists 5 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 10 Jun 2016.