Registo Prospectivo de Histotripsia para Tumores de Tecidos Moles
Histotripsy is a treatment that uses focused ultrasound waves to break down tissue without surgery. The ultrasound waves meet at a specific spot and turn the tissue into liquid. This study is a prospective observational registry of participants receiving histotripsy. The goal of this study is to gather information about the use of histotripsy to confirm it is safe and effective medical procedure.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
CURRENTLY ONY ENROLLING PATIENTS AT UCSF REFERRED BY PHYSICIAN.
PRIMARY OBJECTIVES:
- Tumor response on imaging will be assessed using standardized criteria for tumor types such as European Association for the Study of the Liver (EASL), Response Evaluation Criteria in Solid Tumors (RECIST), and modified RECIST (mRECIST).
- Progression free survival and overall survival.
- Risk factors for adverse events identified by NCI Common Terminology Criteria for Adverse Events (CTCAE).
OUTLINE:
Researchers will collect data from consenting participants' regular doctor visits via medical records for three years after the Histotripsy procedure has taken place.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
-
-
California
-
San Francisco, California, Estados Unidos, 94143
- University of California, San Francisco
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Adult participants diagnosed with soft tissue malignancies receiving care at UCSF who previously received HIFU
Descrição
CURRENTLY ONY ENROLLING PATIENTS AT UCSF REFERRED BY PHYSICIAN.
Inclusion Criteria:
- All adult patients who are treated with histotripsy per standard clinical care at University of California San Francisco (UCSF) are eligible for inclusion in the registry.
Exclusion Criteria:
- Children/minors, and adults who lack decision-making capacity, will be excluded from the registry. Patients who do not consent for inclusion in the registry will also be excluded.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: CASE_ONLY
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Participants with Soft Tissue Tumors
Participant data will be collected from participants' medical records. Cancer history, laboratory analysis, histotripsy procedure details, adverse events, and oncological outcomes of the procedure along with demographic data will be collected. |
Data will be collected from the participants medical records.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Frequency of overall tumor response across all participants
Prazo: up to 3 years
|
Imaging studies will be conducted to assess for a response across all participants (complete response (CR), Partial response (PR), Stable Disease (SD) and Progressive disease (PD) etc.) using the standardized criteria for tumor response assessment. The standard criteria for European Association for the Study of the Liver (EASL), Response Evaluation Criteria in Solid Tumors (RECIST), and modified RECIST (mRECIST) will be used to determine response depending on the participant's soft tissue tumor type |
up to 3 years
|
|
Proportion of participants experienced an adverse event
Prazo: Up to 3 years
|
Proportion of participants with adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0). Adverse events will be evaluated using multivariate analysis. |
Up to 3 years
|
|
Progression free survival (PFS)
Prazo: up to 3 years
|
The analysis of progression-free survival (PFS) will include all participants who have received histotripsy treatment. PFS is defined as the time from the date of histotripsy treatment to the first documented disease progression or death from any cause, whichever occurs first. PFS will be evaluated using time-to-event analysis methods. |
up to 3 years
|
|
Overall Survival (OS)
Prazo: Up to 3 years
|
The analysis of OS include participants who have received histotripsy treatment. OS is defined as the of treatment to the time of death. OS will be evaluated using time-to-event analysis methods. |
Up to 3 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ryan Lokken, MD, University of California, San Francisco
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 254513
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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