Prospective Evaluation of Dynamic Serum ProGRP for Treatment Response Monitoring in Ewing Sarcoma
21 de julho de 2026 atualizado por: Xie Lu, Peking University People's Hospital
This single-center prospective observational study aims to evaluate whether longitudinal changes in serum pro-gastrin-releasing peptide (ProGRP) reflect treatment response in patients with newly diagnosed Ewing sarcoma.
Serum ProGRP levels will be measured before systemic treatment, during neoadjuvant chemotherapy, before local treatment, and after local treatment.
Changes in ProGRP will be compared with radiographic tumor response assessed according to RECIST version 1.1.
The study will also explore the ability of early ProGRP changes to predict objective radiographic response and the association between ProGRP patterns and event-free survival.
ProGRP results obtained for research purposes will not be used to guide clinical treatment decisions.
Visão geral do estudo
Status
Recrutamento
Condições
Descrição detalhada
Patients with newly diagnosed, histologically confirmed Ewing sarcoma who are scheduled to initiate first-line systemic treatment at Peking University People's Hospital will be prospectively enrolled. Treatment selection, including chemotherapy, surgery, and radiotherapy, will be determined by the treating physicians according to routine clinical practice and will not be assigned by the study protocol.
Peripheral blood samples will be collected before the initiation of chemotherapy (T0), after the second or third cycle of neoadjuvant chemotherapy and before the next cycle (T1), after completion of planned neoadjuvant chemotherapy and before definitive local treatment (T2), and at the first routine follow-up visit after surgery or radiotherapy (T3). If longitudinal surveillance is included in the final protocol, additional samples will be collected during routine follow-up.
Serum ProGRP will be measured using an electrochemiluminescence immunoassay. Radiographic response will be assessed according to RECIST version 1.1 by two independent radiologists blinded to the ProGRP results. Disagreements will be resolved by a third reviewer.
The primary analysis will evaluate the correlation between the percentage change in serum ProGRP from T0 to T2 and the percentage change in the sum of diameters of RECIST target lesions over the same period. Secondary analyses will evaluate early prediction of objective response, longitudinal ProGRP patterns, and associations with event-free survival.
Tipo de estudo
Observacional
Inscrição (Estimado)
100
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Lu Xie, M.D.
- Número de telefone: +8613401044719
- E-mail: xie.lu@hotmail.com
Locais de estudo
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Beijing, China
- Recrutamento
- Peking University People's Hospital, Beijing, Beijing 100044
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Contato:
- Lu Xie, M.D.
- Número de telefone: +8613401044719
- E-mail: xie.lu@hotmail.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
The study population will consist of patients aged 10 to 60 years with newly diagnosed, histologically confirmed Ewing sarcoma who are scheduled to initiate first-line systemic therapy at Peking University People's Hospital.
Eligible participants must have at least one evaluable lesion on baseline imaging and must not have received prior systemic chemotherapy for Ewing sarcoma or radiotherapy to the primary tumor.
Participants will receive chemotherapy and definitive local treatment, including surgery and/or radiotherapy, according to routine clinical practice.
Treatment will not be assigned by the study protocol, and serum ProGRP results obtained for research purposes will not be used to guide clinical treatment decisions.
Descrição
Inclusion Criteria:
- Age 10 to 60 years.
- Histologically confirmed Ewing sarcoma.
- Newly diagnosed disease and scheduled to initiate first-line systemic therapy at Peking University People's Hospital.
- No prior systemic chemotherapy for Ewing sarcoma and no prior radiotherapy to the primary tumor.
- At least one evaluable lesion on baseline imaging; at least one measurable lesion according to RECIST version 1.1 is required for the primary outcome analysis.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Estimated life expectancy greater than 3 months.
- Written informed consent provided by the participant or the participant's legally authorized representative.
Exclusion Criteria:
- History of another malignant tumor within the previous 3 years, except for an adequately treated malignancy with a negligible risk of recurrence, as determined by the investigator.
- New York Heart Association (NYHA) class III or IV heart failure.
- Uncontrolled concomitant illness, including uncontrolled diabetes mellitus or an active infection.
- Severe infection requiring intravenous antimicrobial treatment within 4 weeks before enrollment.
- Clinically significant bleeding or a clear bleeding tendency within 3 months before enrollment.
- Severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m².
- Pregnancy or breastfeeding.
- Any condition that, in the investigator's judgment, may compromise participant safety, interfere with study assessments, or prevent compliance with the protocol.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
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Patients With Newly Diagnosed Ewing Sarcoma
Patients with newly diagnosed, histologically confirmed Ewing sarcoma who are scheduled to receive first-line systemic therapy and definitive local treatment according to routine clinical practice.
The study does not assign treatment, and serum ProGRP results will not be used to guide treatment decisions.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Correlation Between the Change in Serum ProGRP and the Change in Tumor Size
Prazo: From baseline to completion of neoadjuvant chemotherapy before definitive local treatment, approximately 4 to 6 months
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The percentage change in serum ProGRP from baseline (T0) to the pre-local-treatment assessment (T2) will be calculated as [(ProGRP at T2 - ProGRP at T0) / ProGRP at T0] × 100%.
The percentage change in tumor size will be calculated using the sum of diameters of RECIST 1.1 target lesions over the same period.
The association between the two continuous variables will be quantified using Spearman's rank correlation coefficient.
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From baseline to completion of neoadjuvant chemotherapy before definitive local treatment, approximately 4 to 6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Accuracy of Early Change in Serum ProGRP for Predicting Objective Radiographic Response
Prazo: From baseline to the pre-local-treatment assessment, approximately 4 to 6 months
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Receiver operating characteristic analysis will be used to evaluate whether the percentage change in serum ProGRP from T0 to T1 predicts objective radiographic response at T2.
Objective response is defined as complete response or partial response according to RECIST version 1.1.
The area under the receiver operating characteristic curve and its 95% confidence interval will be reported.
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From baseline to the pre-local-treatment assessment, approximately 4 to 6 months
|
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Objective Response Rate Before Definitive Local Treatment
Prazo: At completion of neoadjuvant chemotherapy before definitive local treatment, approximately 4 to 6 months after baseline
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Percentage of participants achieving complete response or partial response according to RECIST version 1.1 at the T2 assessment.
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At completion of neoadjuvant chemotherapy before definitive local treatment, approximately 4 to 6 months after baseline
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Longitudinal Change in Serum ProGRP
Prazo: Baseline through the first post-local-treatment follow-up visit, approximately 7 to 9 months
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Serum ProGRP concentration in pg/mL and its percentage change from baseline will be summarized at T1, T2, and T3.
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Baseline through the first post-local-treatment follow-up visit, approximately 7 to 9 months
|
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Event-free Survival
Prazo: From initiation of first-line systemic treatment through 2 years
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Event-free survival is defined as the time from initiation of first-line systemic treatment to the first occurrence of disease progression, local recurrence, a new metastatic lesion, or death from any cause.
Participants without an event will be censored at the date of their last confirmed event-free assessment.
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From initiation of first-line systemic treatment through 2 years
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de setembro de 2025
Conclusão Primária (Estimado)
1 de setembro de 2026
Conclusão do estudo (Estimado)
1 de setembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
21 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de julho de 2026
Primeira postagem (Real)
24 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
24 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PKUPH-sarcoma 26
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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