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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in France

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.

Keywords
Skeletal age, Chronological age, Adolescent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Medical response transmitted to courts regarding age determination, at the end of medical examination

    Measured: One hour

Secondary outcomes (1)
  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.

  1. First posted13 Apr 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionApr 2013
  4. Study completionMar 2014

Resources

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)
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 20133398
  • Buken 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 17391883
  • Schmeling 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 11463408
  • Garamendi 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 16182943
  • Hassanali 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

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.

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