Estude para saber mais sobre a segurança e a eficácia do medicamento VITRAKVI durante o uso rotineiro em pacientes com câncer de fusão TRK que é localmente avançado ou se espalhou do local onde começou para outros locais do corpo (ON-TRK)
Estudo Prospectivo Não Intervencionista em Pacientes com Câncer de Fusão TRK Localmente Avançado ou Metastático Tratados com Larotrectinibe
In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use in patients with TRK fusion cancer which is locally advanced or spread from the place where it started to other places in the body. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Many Locations, Alemanha
- Many Locations
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Many Locations, Argentina
- Many Locations
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Many Locations, Bélgica
- Many Locations
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Many Locations, Canadá
- Many Locations
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Many Locations, China
- Many Locations
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Many Locations, Coréia do Sul
- Many Locations
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Many Locations, Espanha
- Many Locations
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California
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Los Angeles, California, Estados Unidos, 90095
- UCLA - Mattel Children's Hospital
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Los Angeles, California, Estados Unidos, 90027
- California Research Inst.
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Newport Beach, California, Estados Unidos, 82663
- Hoag Memorial Hospital Presbyterian
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Palo Alto, California, Estados Unidos, 94304
- Stanford Univ Med Ctr. / Lucile Packard Children's Hosp
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Santa Monica, California, Estados Unidos, 90404
- Providence Health System - Southern California
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Torrance, California, Estados Unidos, 90502
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06520
- Yale University
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Florida
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Miami, Florida, Estados Unidos, 33155
- Nicklaus Children's Hospital
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Miami, Florida, Estados Unidos, 33146
- University of Miami
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Indiana
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Fort Wayne, Indiana, Estados Unidos, 46804
- Fort Wayne Medical Oncology Hematology
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Kansas
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Wichita, Kansas, Estados Unidos, 67214
- Cancer Center of Kansas
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Maine
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South Portland, Maine, Estados Unidos, 04106
- Maine Health
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Maryland
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Baltimore, Maryland, Estados Unidos, 21205
- Johns Hopkins / Sidney Kimmel Cancer Center
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Frederick, Maryland, Estados Unidos, 21702
- Frederick Health-James M Stockman Cancer Institute
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02111
- Tufts / Neely Cancer Center
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Michigan
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Farmington Hills, Michigan, Estados Unidos, 48334
- Detroit Clinical Research Center
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Lansing, Michigan, Estados Unidos, 48912
- Sparrow Cancer Center
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89169
- Nevada Cancer Research Foundation
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New York
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Buffalo, New York, Estados Unidos, 14210
- Great Lakes Cancer Center
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New York, New York, Estados Unidos, 10065
- Memorial Sloan Kettering Children's Cancer Center
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North Carolina
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Greenville, North Carolina, Estados Unidos, 27834
- East Carolina University / Vidant Health
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Ohio
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Youngstown, Ohio, Estados Unidos, 44501
- Mercy Health Youngstown
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Estados Unidos, 15212
- Allegheny Health Network
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425
- Medical Univ. of South Carolina
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, Estados Unidos, 75390
- UT Southwestern Medical Center / Children's Health
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Houston, Texas, Estados Unidos, 77030
- MD Anderson Cancer Center
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Utah
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Salt Lake City, Utah, Estados Unidos, 84112
- Univ. of Utah / Huntsman Cancer Center
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Washington
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Seattle, Washington, Estados Unidos, 98105
- Seattle Children's
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West Virginia
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Morgantown, West Virginia, Estados Unidos, 26506
- West Virginia University
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Wisconsin
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La Crosse, Wisconsin, Estados Unidos, 54601
- Gundersen Health System
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Madison, Wisconsin, Estados Unidos, 53717
- SSM Health Cancer Center - Dean Medical Group
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Many Locations, Finlândia
- Many Locations
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Many Locations, França
- Many Locations
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Many Locations, Itália
- Many Locations
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Many Locations, Luxemburgo
- Many Locations
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Many Locations, Suécia
- Many Locations
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Many Locations, Suíça
- Many Locations
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Many Locations, Áustria
- Many Locations
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Adult and pediatric (from birth to 18-year-old) patients with a locally advanced or metastatic solid tumor harboring an NTRK gene fusion (detected by NGS (Next-Generation Sequencing), FISH (Fluorescent In Situ Hybridization), rt-PCR (Reverse Transcription Polymerase Chain Reaction) or other genomic testing able to detect NTRK gene fusion) assessed locally for whom a decision to treat with larotrectinib has been made before enrollment
Descrição
Inclusion Criteria:
- Adult and pediatric (from birth to 18-year-old) patients
- Patients with locally advanced or metastatic solid tumor harboring an NTRK gene fusion. NTRK (NTRK1, NTRK2, and NTRK3) gene fusions will be identified locally. Acceptable methods of detection of NTRK gene fusion include NGS, fluorescence in situ hybridization (FISH), reverse-transcription polymerase chain reaction (rt-PCR) or any other genomic testing able to detect NTRK gene fusion. If a pan-TRK IHC method is used, this result needs to be accompanied with the results using one of the other methods noted above.
- Life expectancy of at least 3 months based on clinical judgement
- Decision to treat with larotrectinib made by the treating physician prior to study enrollment
- Patients can also be enrolled if the initial visit (larotrectinib start date) occurred within 2 months ±3 days prior to informed consent signed date
- Signed informed consent form
- For patients under legal age, signed assent by the patient (where applicable) and parental/legal guardian signed informed consent is required
Exclusion Criteria:
- Any contraindications as listed in the local approved product information
- Pregnancy
- Participation in an investigational program with interventions outside of routine clinical practice
- Prior treatment with larotrectinib or other kinase inhibitor with TRK inhibition
- Patients with NTRK gene amplification or NTRK point mutation
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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GI
adult patients with gastrointestinal (GI) cancer |
In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol |
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H&N
adult patients with head and neck (H&N) cancer |
In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol |
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STS
adult patients with soft tissue sarcoma (STS) |
In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol |
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CNS
adult patients with primary central nervous system (CNS) cancer |
In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol |
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Lung
adult patients with lung cancer |
In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol |
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Melanoma
adult patients with melanoma |
In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol |
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Pediatric
all pediatric patients regardless of tumor type will be enrolled under this cohort |
In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol |
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other
patients with other tumor types |
In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Número de participantes com eventos adversos emergentes do tratamento (TEAEs)
Prazo: Até 30 dias após a última dose
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Até 30 dias após a última dose
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Gravidade dos TEAEs
Prazo: Até 30 dias após a última dose
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Até 30 dias após a última dose
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Gravidade dos TEAEs
Prazo: Até 30 dias após a última dose
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Até 30 dias após a última dose
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Causalidade de TEAEs
Prazo: Até 30 dias após a última dose
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Até 30 dias após a última dose
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Ação tomada relacionada ao tratamento com larotrectinibe
Prazo: Até 30 dias após a última dose
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Até 30 dias após a última dose
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Relação causal razoável entre larotrectinibe e um EA
Prazo: Até 30 dias após a última dose
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Até 30 dias após a última dose
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Taxa de resposta objetiva (ORR)
Prazo: Até 8 anos
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Até 8 anos
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Taxa de controle de doenças (DCR)
Prazo: Até 8 anos
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Até 8 anos
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Duração da resposta (DOR)
Prazo: Até 8 anos
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Até 8 anos
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Tempo de resposta (TTR)
Prazo: Até 8 anos
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Até 8 anos
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Sobrevida livre de progressão (PFS)
Prazo: Até 8 anos
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Até 8 anos
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Sobrevida global (OS)
Prazo: Até 8 anos
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Até 8 anos
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Dose total
Prazo: Até 8 anos
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Até 8 anos
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Dose inicial e final
Prazo: Até 8 anos
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Até 8 anos
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Modificação da dose durante o tratamento
Prazo: Até 8 anos
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Até 8 anos
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Duração do tratamento (DOT)
Prazo: Até 8 anos
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Até 8 anos
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ORR por subgrupo(s) de pacientes
Prazo: Até 8 anos
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Até 8 anos
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DCR por subgrupo(s) de pacientes
Prazo: Até 8 anos
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Até 8 anos
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DOR por subgrupo(s) de pacientes
Prazo: Até 8 anos
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Até 8 anos
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TTR por subgrupo(s) de pacientes
Prazo: Até 8 anos
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Até 8 anos
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PFS por subgrupo(s) de pacientes
Prazo: Até 8 anos
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Até 8 anos
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SO por subgrupo(s) de pacientes
Prazo: Até 8 anos
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Até 8 anos
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Number of patients with change in height and weight from baseline by visit, neurological abnormalities (normal/abnormal)
Prazo: Up to 8 years
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for all patients |
Up to 8 years
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Number of patients with abnormal developmental milestones
Prazo: Up to 8 years
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Pediatric cohort only |
Up to 8 years
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Number of patients with abnormal Tanner stage
Prazo: Up to 8 years
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Pediatric cohort only |
Up to 8 years
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 20324
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Informações sobre medicamentos e dispositivos, documentos de estudo
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