Prospective Evaluation of Dynamic Serum ProGRP for Treatment Response Monitoring in Ewing Sarcoma (NCT07725783) | Clinical Trial Compass
RecruitingNot Applicable
Prospective Evaluation of Dynamic Serum ProGRP for Treatment Response Monitoring in Ewing Sarcoma
China100 participantsStarted 2025-09-01
Plain-language summary
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.
Who can participate
Age range
10 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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