- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT04868097
Predicting Adjuvant Post-operative Radiation Therapy in Patients With Cervical Cancer Stage IB2
Predicting the Presence of Histologic Criteria for Adjuvant Post-operative Radiation of Patients With Cervical Cancer Stage IB2 by Large Loop Biopsy Prior to Surgery
A pre- operative evaluation for the presence of intermediate risk factors prior to surgery may allow for better patient counselling, modify the course of surgery or select patients to undergo primary chemo- radiation.
The purpose of this study is to validate that the presence of histological risk factors in a pre-operative large loop biopsy highly correlates with post-operative histological evaluation and the subsequent indication for post-operative chemo-radiation
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Patients with cervical cancer who are scheduled for radical hysterectomy and underwent a pre- operative MRI and PET- CT that have demonstrated a tumor ≥2- 4cm cm and the absence of nodal metastasis on imaging will be offered to give consent and participate.
After anesthesia and immediately prior to surgery, the surgeon will perform a large loop biopsy of depth of 1.5 and a diameter of 1.0 cm from the cervical tumor. Hemostasis can be achieved by the usual measures or by packing. Surgery will follow immediately as planned.
In patient who in the course of the preoperative evaluation underwent large loop biopsy histologic analysis of this biopsy will be performed similarly. If the large loop specimen is appropriate (>1.5X1cm) and allows assessment of all the histologic risk factors, no repeat large loop biopsy will be performed.
In patient that the that the previous large loop biopsy is not be appropriate for complete histologic analysis and the surgeon asses that a repeat biopsy is technically feasible, a large loop biopsy will be performed prior to the radical hysterectomy as described above.
All histological evaluation will be carried out as usual in hospital in which the surgery was performed.
In addition, centralized pathological analysis will be performed in Hillel Yaffe Medical center The histopathological features to be included in the report: type of procedure, tumor site, histologic type of tumor, histologic grade, depth of stromal invasion, pattern of invasion (*), horizontal extent of stromal invasion, the distance of tumor from surgical margins, lymphovascular invasion, LVSI will be assess and reported after D2-40and CD31 immunostatins.
Descriptive demographic, clinical and pathology data will be noted. The histopathological features noted above and size of tumor as measured on MRI will be recorded.
The rate of the presence of both LVSI and invasion greater 10 mm in the pre- operative loop biopsy will be assessed.
At least 52 patients will be included in the study
Sample size calculation:
The minimal sample size required to demonstrate the non-inferiority of Method B (findings in LEEP) is 52. Assuming that the proportions of patients with the presence of both LVSI and tumor invasion greater than 10 mm, method A (standard post- surgery evaluation) and method B are 25%, with α=0.05, β=0.2, and non-inferiority margin of 15%.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Reẖovot, Israel, 76100
- Recrutamento
- Kaplan Medical Center
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Contato:
- Alon Ben arie, MD
- Número de telefone: 972-502460001
- E-mail: alon_b@clalit.org.il
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Contato:
- Yael Avidan, MD
- Número de telefone: 972-0528082201
- E-mail: yaelav1@clalit.org.il
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
- Patients with cervical cancer who are scheduled for radical hysterectomy and underwent a pre- operative imaging (MRI and PET CT) that have demonstrated a tumor ≥2-4 cm and the absence of nodal metastasis.
- Pre -operative assessment by the surgeon that a large loop biopsy of depth of 1.5 and a diameter of 1 cm is technically feasible.
- Patient who in the course of the preoperative evaluation underwent large loop biopsy of depth of 1.5 and a diameter of 1.0 cm, and in the subsequent evaluation fulfilled the criteria in (1).
Exclusion Criteria:
Patient who do not sign the informed consent. Patient who is scheduled for Chemoradiation Patients with large loop biopsy which is smaller than depth of 1.5 and a diameter of 1.0 cm
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
The rate of LVSI in Cervix cancer
Prazo: two years
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Pre operative presence of LVSI in loop biopsy in cervical cancer, compared to post operative LVSI rate in hysterectomy Specimen
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two years
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
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
- 0186-20-KMC (Outro identificador: Kaplan Medical Center)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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