NCT07725783Recruiting
Prospective Evaluation of Dynamic Serum ProGRP for Treatment Response Monitoring in Ewing Sarcoma
Source: ClinicalTrials.gov · Last updated 24 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 21 Jul 2026
- Start date
- 1 Sept 2025
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Peking University People's Hospital
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT07725783
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Sept 2025 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- Any condition that, in the investigator's judgment, may compromise participant safety, interfere with study assessments, or prevent compliance with the protocol.
Lab values
- Severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m².
Other
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 10 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital, Beijing, Beijing 100044 Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.