Dynamic ProGRP Changes During Ewing Sarcoma Treatment
Official title: Prospective Evaluation of Dynamic Serum ProGRP for Treatment Response Monitoring in Ewing Sarcoma
Run by Peking University People's Hospital · NCT07725783 · Data updated 2026-11-12
This study tests whether changes in serum ProGRP levels over time reflect how well newly diagnosed Ewing sarcoma responds to treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 10 Years to 60 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | September 1, 2026 |
| Study ends | September 1, 2026 |
| Registry record updated | July 24, 2026 |
| Trial ID | NCT07725783 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Candidates are patients aged 10-60 with newly diagnosed, histologically confirmed Ewing sarcoma scheduled for first-line systemic therapy at Peking University People’s Hospital.
✕Probably not a fit
Patients whose tumor biology does not influence ProGRP levels or who have non-measurable disease may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this single-center observational study, researchers will collect blood samples at four key time points and compare ProGRP changes with tumor size changes on RECIST imaging. Radiologists will assess imaging independently to see if early ProGRP shifts can predict radiographic response. The goal is to understand whether ProGRP could serve as a biomarker for treatment response, without affecting clinical decisions.
Why it matters
Potential benefit: If ProGRP reliably tracks response, it could offer a less invasive tool to monitor how well treatment is working.
How similar studies have gone: Previous biomarker studies in Ewing sarcoma have explored serum markers, but the use of ProGRP as a treatment-response biomarker is novel in this setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Peking University People's Hospital, Beijing, Beijing 100044
Beijing, China Recruiting
Study contacts
- Study coordinator: Lu Xie, M.D.
- Email: xie.lu@hotmail.com
- Phone: +8613401044719
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.