Prospective Evaluation of Dynamic Serum ProGRP for Treatment Response Monitoring in Ewing Sarcoma
21 de julio de 2026 actualizado 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
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 estudio
De observación
Inscripción (Estimado)
100
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Lu Xie, M.D.
- Número de teléfono: +8613401044719
- Correo electrónico: xie.lu@hotmail.com
Ubicaciones de estudio
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Beijing, Porcelana
- Reclutamiento
- Peking University People's Hospital, Beijing, Beijing 100044
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Contacto:
- Lu Xie, M.D.
- Número de teléfono: +8613401044719
- Correo electrónico: xie.lu@hotmail.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Correlation Between the Change in Serum ProGRP and the Change in Tumor Size
Periodo de tiempo: 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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Accuracy of Early Change in Serum ProGRP for Predicting Objective Radiographic Response
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de septiembre de 2025
Finalización primaria (Estimado)
1 de septiembre de 2026
Finalización del estudio (Estimado)
1 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
21 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
21 de julio de 2026
Publicado por primera vez (Actual)
24 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
21 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PKUPH-sarcoma 26
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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