The 3rd COPENHAGEN Puberty Study

NCT04884620 | Recruiting

• 1 other identifier: CopenhagenPuberty3
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

The COPENHAGEN School Study is a combined cross-sectional and longitudinal study of healthy Danish school children. This study will by clinical examinations and withdrawal of blood samples investigate whether age of pubertal onset is continuing to decline in Denmark over the past 15 years. Furthermore, we will investigate the mechanism driving earlier onset of puberty and the long term health risks of extremely early puberty using Danish registry data

Conditions

Puberty; Puberty, Precocious

Outcome Measures

Primary Outcomes (2)

• Pubertal development

  Pubertal onset according to Tanner criteria: * Girls was investigated for assessment of breast development stage B1-5 (by palpation), pubic hair staging PH1-5, occurrence of axillary hair (Stage 0-2), menarche, sweat and acne. * Boys was examined in order to assess their genitalia development stage G1-5, pubic hair stage PH1-6, occurrence of axillary hair, acne, sweat, voice break and testicular volume (Praders orchidometer30).

  Up to an 8 year period

• Long-term disease and death risk after extremely early puberty

  Diagnoses include cancer (prostate and breast), metabolic syndrome, diabetes type 2, cardiovascular disorders (coronary heart disease, heart failure, stroke), and mental health outcomes (depression (major or chronic), anxiety, attempted suicide). Information on the outcomes of interest were extracted from national registers including the National Patient Register, Psychiatric Central Research Registry, National Prescription Registry, Cancer Registry, Causes of Death Registry40 and Medical Birth Registry.

  Up to a 20 year period

Study Arms (2)

Cross-sectional cohort

Healthy children and adolescents from twenty-five selected schools in the metropolitan area

Longitudinal cohort

Cases with first-time diagnoses of extremely early puberty within the period 1995-2019 in the National Patient Registry and five randomly selected references drawn from the general background population in the Danish Civil registry (CPR) matched on age and sex for each case

Eligibility Criteria

• Age: 5 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Cross-sectional population-based puberty study: All children and adolescents from 25 selected schools in the metropolitan area were invited to participate in the study Longitudinal register-based follow up study of children with precocious puberty: All hospital patient records of first-time diagnoses of extremely early puberty within the period 1995-2019 was identified (N=8596) in the National Patient Registry. Five randomly selected persons matched on age and sex for each case of extremely early puberty diagnosis were drawn from the general background population in the Danish Civil registry (CPR) (n=42,980)

You may qualify if:

• Healthy children and adolescents

You may not qualify if:

• In case of acute disease, cancer, cancer therapy, or chronic disease (History of malignant disease, chemotherapy or radiation, cystic fibrosis, juvenile rheumatoid arthritis, systemic lupus erythematosus, sickle cell disease, thalassemia, chronic renal disease or known numerical chromosome aberration)
• Non-Caucasian

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Environmental Protection Agency (EPA): collaborator
• European Commission: collaborator

Study Sites (1)

Rigshospitalet, Department of Growth and Reproduction

Copenhagen, 2100, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples, serum, white cells, urine, dried blood spots. DNA and RNA will be isolated and amplified from collected blood samples and stored. Only specific primers targeted at known SNPs in genes with established or theoretic effects on hormone production, modification or receptor sensitivity or SNP arrays covering common variants (≥1% minor allele frequency, based on allele frequency of the population reference in the current standard, e.g. "The Haplotype Reference Consortium") will be used for genetic analysis. Genetic analysis will not include extensive mapping of the human genome. SNP array data are important at the group level for scientific purposes, but not valid for making clinical judgments on the individual level on the health of the participants. We will not determine any genetic diseases. The participants will not be informed of the results of their individual genetic makeup, only group level information will be available.

MeSH Terms

Conditions

Puberty, Precocious

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Officials

• Anders Juul, PhD, DMSc

  Rigshospitalet, Department of Growth and Reproduction

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anders Juul, PhD, DMSc

CONTACT

+45 35 45 13 77; anders.juul@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anders Juul, Rigshospitalet, Denmark

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 13, 2021
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2056
• Last Updated: January 10, 2024

Record last verified: 2024-01

Locations

DK (1)