Clinical trial · Observational
Prospective Evaluation of Dynamic Serum ProGRP for Treatment Response Monitoring in Ewing Sarcoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ewing Sarcoma | Ewing Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients With Newly Diagnosed Ewing Sarcoma
- description
- 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.
Primary outcomes (1)
- measure
- Correlation Between the Change in Serum ProGRP and the Change in Tumor Size
- timeFrame
- From baseline to completion of neoadjuvant chemotherapy before definitive local treatment, approximately 4 to 6 months
- description
- 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.
Secondary outcomes (4)
- measure
- Accuracy of Early Change in Serum ProGRP for Predicting Objective Radiographic Response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available