Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-27 @ 7:57 PM
Study NCT ID:
NCT06263868
Status:
RECRUITING
Last Update Posted:
2025-03-10
First Post:
2024-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First Observatory of Precocious Puberty.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011629', 'term': 'Puberty, Precocious'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3360}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-06-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-07', 'studyFirstSubmitDate': '2024-02-09', 'studyFirstSubmitQcDate': '2024-02-09', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of recruited patients with at least 80% of the main data collected', 'timeFrame': 'Up to 48 month', 'description': 'Number of recruited patients with at least 80% of the main data collected (weight, height, BMI, pubertal stage, date of onset of pubertal signs, questionnaires).'}, {'measure': 'Missing data rate', 'timeFrame': 'Up to 48 month', 'description': 'Missing data rate less than 10% for pubertal stage.'}, {'measure': 'At least 75% of patients included', 'timeFrame': 'Up to 48 month', 'description': 'At least 75% of patients included compared to the number of eligible patients.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Early/precocious puberty', 'advanced puberty', 'national observatory', 'private medicine', 'feasibility'], 'conditions': ['Puberty, Precocious']}, 'descriptionModule': {'briefSummary': 'The age of puberty has fluctuated throughout history. Recent data shows an increase in the age of onset of puberty signs, in the United States but also in Europe. A recent Public Health France study published in 2018 reports an increase in the incidence of precocious puberty with geographical heterogeneity. The consequences of these appearances include the early onset of menarche, short adult height and the psychological impact.\n\nDue to a lack of studies and additional data, the reasons for this development are difficult to understand. Among current hypotheses, the entanglement with the evolution of our environment is at the forefront: the action of environmental endocrine disruptors and nutritional factors could play a role in the process of early appearance of pubertal signs.\n\nThe establishment of a national observatory for early and advanced puberty in collaboration with pediatric endocrinologists (on the front line) would allow a reliable and precise field approach, capable of supplementing epidemiological data, which are currently insufficient.\n\nThe investigators hypothesize that the establishment of an observatory of pubertal advances (early puberty and advanced puberty) in private medicine is possible, with inclusion of at least 75% of eligible patients, and collection of at least 80% of data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be recruited in private heathlcare: 2880 patients distributed between the 2 following groups: PP (Precocious puberty group) and PA (Advanced puberty group), and 480 children in the control group.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPrecocious puberty group (PP) :\n\n* Suspected precocious puberty (girl aged \\< 8 years or boy aged \\< 9 years when the first signs of development\\* appear)\n* Suspected precocious puberty (girl aged \\< 8 years or boy aged \\< 9 years when the first signs of development\\* appear)\n\nAdvanced puberty group (AP) :\n\n* Suspected advanced puberty (girl aged ≥ 8 and \\< 10 years or boy aged ≥ 9 and \\< 11 years when the first signs of development\\* appear)\n* First consultation with the investigator (pediatric endocrinologist).\n\nControl group :\n\n* Boy or girl without signs of pubertal development (Tanner 1);\n* Matched to the PP group on sex and age (+/- 1 year);\n* Consultation with the same investigator over the same period (same quarter) as a patient in the PP group\n\nExclusion Criteria:\n\nAll groups\n\n* Consultation with the same investigator over the same period (same quarter) as a patient in the PP group\n* Family not speaking French, language barrier.'}, 'identificationModule': {'nctId': 'NCT06263868', 'acronym': 'PAPPEL', 'briefTitle': 'First Observatory of Precocious Puberty.', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'First Observatory of Precocious and Advanced Puberty in Private Healthcare.', 'orgStudyIdInfo': {'id': '69HCL23_1090'}, 'secondaryIdInfos': [{'id': '2023-A02313-42', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Precocious puberty group', 'description': 'Girl \\< 8 years old or boy \\< 9 years old when the first signs of development appear.'}, {'label': 'Advanced puberty group', 'description': 'Girl aged ≥ 8 and \\< 10 years or boy ≥ 9 and \\< 11 years old when the first signs of development appear.'}, {'label': 'Control group', 'description': 'Boy or girl without any signs of puberty development (Tanner 1)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69130', 'city': 'Écully', 'state': 'Auvergne-Rhône-Alpes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilie Doye, MD', 'role': 'CONTACT', 'email': 'emilie.doye@chu-lyon.fr', 'phone': '0472118890', 'phoneExt': '33'}, {'name': 'Emilie Doye, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Clinique du Val d'Ouest", 'geoPoint': {'lat': 45.77437, 'lon': 4.77758}}, {'zip': '69130', 'city': 'Écully', 'state': 'Auvergne-Rhône-Alpes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilie Beaufils, MD', 'role': 'CONTACT', 'email': 'pediatre.beaufils@gmail.com', 'phone': '0658187556', 'phoneExt': '33'}, {'name': 'Emilie Beaufils, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Clinique du Val d'Ouest", 'geoPoint': {'lat': 45.77437, 'lon': 4.77758}}, {'zip': '69130', 'city': 'Écully', 'state': 'Auvergne-Rhône-Alpes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mélanie Daval Cote, MD', 'role': 'CONTACT', 'email': 'drdavalcote@yahoo.fr', 'phone': '0472193310', 'phoneExt': '33'}, {'name': 'Mélanie Daval Cote, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Clinique du Val d'Ouest", 'geoPoint': {'lat': 45.77437, 'lon': 4.77758}}, {'zip': '69006', 'city': 'Lyon', 'state': 'Auvergne-Rhône-Alpes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Prisca DEALBERTI, MD', 'role': 'CONTACT', 'email': 'dr.dealberti@gmail.com', 'phone': '04 72 83 50 01', 'phoneExt': '33'}, {'name': 'Prisca DEALBERTI, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pediatric practice', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '35200', 'city': 'Rennes', 'state': 'Brittany Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Livie CHATELAIS, MD', 'role': 'CONTACT', 'email': 'lchatelais@yahoo.fr', 'phone': '02 99 86 77 57', 'phoneExt': '33'}, {'name': 'Livie CHATELAIS, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pediatric practice', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '37170', 'city': 'Chambray-lès-Tours', 'state': 'Centre-Val de Loire', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Caroline HASSELMAN, MD', 'role': 'CONTACT', 'email': 'chasselmann@mac.com', 'phone': '02 46 65 07 45', 'phoneExt': '33'}, {'name': 'Caroline HASSELMAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pediatric practice', 'geoPoint': {'lat': 47.33537, 'lon': 0.70286}}, {'zip': '54270', 'city': 'Essey-lès-Nancy', 'state': 'Grand Est', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julie AUGER, MD', 'role': 'CONTACT', 'email': 'dr.augerjulie@gmail.com', 'phone': '03 83 21 01 11', 'phoneExt': '33'}, {'name': 'Julie AUGER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pediatric practice', 'geoPoint': {'lat': 48.705, 'lon': 6.22691}}, {'zip': '92300', 'city': 'Levallois-Perret', 'state': 'Hauts-de-Seine', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Pediatric practice', 'geoPoint': {'lat': 48.89389, 'lon': 2.28864}}, {'zip': '37230', 'city': 'Fondettes', 'state': 'Indre-et-Loire', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Myriam BOUILLO, MD', 'role': 'CONTACT', 'email': 'myriam.bouillo@orange.fr', 'phone': '02 47 66 45 52', 'phoneExt': '33'}, {'name': 'Myriam BOUILLO, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pediatric practice', 'geoPoint': {'lat': 47.4035, 'lon': 0.59686}}, {'zip': '33310', 'city': 'Lormont', 'state': 'Nouvelle-Aquitaine', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Polyclinique Bordeaux rive droite', 'geoPoint': {'lat': 44.8765, 'lon': -0.51919}}, {'zip': '64000', 'city': 'Pau', 'state': 'Nouvelle-Aquitaine', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catie CESSANS, MD', 'role': 'CONTACT', 'email': 'pediatre.cessans@gmail.com', 'phone': '06 15 82 62 59', 'phoneExt': '33'}, {'name': 'Catie CESSANS, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pediatric practice', 'geoPoint': {'lat': 43.31117, 'lon': -0.35583}}, {'zip': '33600', 'city': 'Pessac', 'state': 'Nouvelle-Aquitaine', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier PUEL, MD', 'role': 'CONTACT', 'email': 'opuel@free.fr', 'phone': '0556453585', 'phoneExt': '33'}, {'name': 'Olivier PUEL, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pediatric Practice', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '31300', 'city': 'Toulouse', 'state': 'Occitanie', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Adelaïde DURAND, MD', 'role': 'CONTACT', 'email': 'dr.durand@cliniquerivegauche.fr', 'phone': '05 67 77 51 31', 'phoneExt': '33'}, {'name': 'Adelaïde DURAND, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique rive gauche', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '44600', 'city': 'Saint-Nazaire', 'state': 'Pays de la Loire Region', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Isabelle GUEMAS, MD', 'role': 'CONTACT', 'email': 'isabelleguemas@gmail.com', 'phone': '02 40 53 88 91', 'phoneExt': '33'}, {'name': 'Isabelle GUEMAS, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pediatric practice', 'geoPoint': {'lat': 47.27506, 'lon': -2.2179}}, {'zip': '13090', 'city': 'Aix-en-Provence', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Céline CASTAINGS-CARLIOZ, MD', 'role': 'CONTACT', 'email': 'celine.carlioz@yahoo.fr', 'phone': '06 20 70 02 99', 'phoneExt': '33'}, {'name': 'Céline CASTAINGS-CARLIOZ, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pediatric practice', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '69677', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilie Doye, MD', 'role': 'CONTACT', 'email': 'emilie.doye@chu-lyon.fr', 'phone': '0472118890'}, {'name': 'Emilie Doye, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Femme Mère Enfant, Hospices civils de Lyon', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '13008', 'city': 'Marseille', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Pediatric practice', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13012', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catherine BRUE FABRE', 'role': 'CONTACT', 'email': 'catherine.brue@gmail.com', 'phone': '04 91 49 29 35', 'phoneExt': '33'}, {'name': 'Catherine BRUE FABRE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pediatric practice', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '06000', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédérique GASTAUD, MD', 'role': 'CONTACT', 'email': 'docteurgastaud.frederique@orange.fr', 'phone': '04 93 13 85 17', 'phoneExt': '33'}, {'name': 'Frédérique GASTAUD, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pediatric practice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '34430', 'city': 'Saint-Jean-de-Védas', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Clinique Saint jean', 'geoPoint': {'lat': 43.57759, 'lon': 3.82603}}, {'zip': '49800', 'city': 'Trélazé', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julie CHEIGNON, MD', 'role': 'CONTACT', 'email': 'julie.cheignon@wanadoo.fr', 'phone': '02 41 79 08 09', 'phoneExt': '33'}, {'name': 'Julie CHEIGNON, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pediatric practice', 'geoPoint': {'lat': 47.44629, 'lon': -0.46652}}, {'zip': '75010', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Capucine VIGNON SAVOYE, MD', 'role': 'CONTACT', 'email': 'capucinevignon@free.fr', 'phone': '09 80 46 71 19', 'phoneExt': '33'}, {'name': 'Capucine VIGNON SAVOYE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pediatric practice', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75011', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Isabelle FLECHTNER, MD', 'role': 'CONTACT', 'email': 'drflechtner@gmail.com', 'phone': '01 43 55 17 17', 'phoneExt': '33'}, {'name': 'Isabelle FLECHTNER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pediatric practice', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75017', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Maxime GERARD, MD', 'role': 'CONTACT', 'email': 'm.gerard.endocped@gmail.com', 'phone': '06 37 63 83 07', 'phoneExt': '33'}, {'name': 'Maxime GERARD, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pediatric practice', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75116', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Pediatric practice', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Emillie Doye, MD', 'role': 'CONTACT', 'email': 'emilie.doye@chu-lyon.fr', 'phone': '0472118890', 'phoneExt': '+33'}, {'name': 'Tiphanie GINHOUX', 'role': 'CONTACT', 'email': 'Tiphanie.ginhoux01@chu-lyon.fr', 'phone': '0427857723', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'Emillie DOYE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}