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

Sponsor
Peking University People's Hospital
Study ID
NCT07725783
Status
Recruiting
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Conditions

  • Ewing Sarcoma

Eligibility Criteria

Sex
ALL
Age
10 Years - 60 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Jul 24, 2026
Start date
Sep 1, 2025
Status verified
Jul 2026
Primary completion
Sep 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Correlation Between the Change in Serum ProGRP and the Change in Tumor Size [ Time Frame: From baseline to completion of neoadjuvant chemotherapy before definitive local treatment, approximately 4 to 6 months ]

Central Contacts

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