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Prospective Evaluation of Dynamic Serum ProGRP for Treatment Response Monitoring in Ewing Sarcoma

21 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

100

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
      • Beijing, Chine
        • Recrutement
        • Peking University People's Hospital, Beijing, Beijing 100044
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Correlation Between the Change in Serum ProGRP and the Change in Tumor Size
Délai: From baseline to completion of neoadjuvant chemotherapy before definitive local treatment, approximately 4 to 6 months
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.
From baseline to completion of neoadjuvant chemotherapy before definitive local treatment, approximately 4 to 6 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Accuracy of Early Change in Serum ProGRP for Predicting Objective Radiographic Response
Délai: From baseline to the pre-local-treatment assessment, approximately 4 to 6 months
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.
From baseline to the pre-local-treatment assessment, approximately 4 to 6 months
Objective Response Rate Before Definitive Local Treatment
Délai: At completion of neoadjuvant chemotherapy before definitive local treatment, approximately 4 to 6 months after baseline
Percentage of participants achieving complete response or partial response according to RECIST version 1.1 at the T2 assessment.
At completion of neoadjuvant chemotherapy before definitive local treatment, approximately 4 to 6 months after baseline
Longitudinal Change in Serum ProGRP
Délai: Baseline through the first post-local-treatment follow-up visit, approximately 7 to 9 months
Serum ProGRP concentration in pg/mL and its percentage change from baseline will be summarized at T1, T2, and T3.
Baseline through the first post-local-treatment follow-up visit, approximately 7 to 9 months
Event-free Survival
Délai: From initiation of first-line systemic treatment through 2 years
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.
From initiation of first-line systemic treatment through 2 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Peking University People's Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 septembre 2025

Achèvement primaire (Estimé)

1 septembre 2026

Achèvement de l'étude (Estimé)

1 septembre 2026

Dates d'inscription aux études

Première soumission

21 juillet 2026

Première soumission répondant aux critères de contrôle qualité

21 juillet 2026

Première publication (Réel)

24 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • PKUPH-sarcoma 26

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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