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

NCT07725783 | Recruiting

• 1 other identifier: PKUPH-sarcoma 26
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ewing Sarcoma

Keywords

ProGRP; Biomarker; Treatment Response; Neoadjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Correlation Between the Change in Serum ProGRP and the Change in Tumor Size

  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.

  From baseline to completion of neoadjuvant chemotherapy before definitive local treatment, approximately 4 to 6 months

Secondary Outcomes (4)

• Accuracy of Early Change in Serum ProGRP for Predicting Objective Radiographic Response

  From baseline to the pre-local-treatment assessment, approximately 4 to 6 months

• Objective Response Rate Before Definitive Local Treatment

  At completion of neoadjuvant chemotherapy before definitive local treatment, approximately 4 to 6 months after baseline

• Longitudinal Change in Serum ProGRP

  Baseline through the first post-local-treatment follow-up visit, approximately 7 to 9 months

• Event-free Survival

  From initiation of first-line systemic treatment through 2 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients aged 10 to 60 years with newly diagnosed, histologically confirmed Ewing sarcoma who are scheduled to initiate first-line systemic therapy at Peking University People's Hospital. Eligible participants must have at least one evaluable lesion on baseline imaging and must not have received prior systemic chemotherapy for Ewing sarcoma or radiotherapy to the primary tumor. Participants will receive chemotherapy and definitive local treatment, including surgery and/or radiotherapy, according to routine clinical practice. Treatment will not be assigned by the study protocol, and serum ProGRP results obtained for research purposes will not be used to guide clinical treatment decisions.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital, Beijing, Beijing 100044

Beijing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples will be collected at predefined treatment and follow-up time points. Samples will be aliquoted and stored at -80°C. Serum ProGRP concentrations will be measured using an electrochemiluminescence immunoassay. Remaining samples may be retained for research analyses specified in the ethics-approved protocol and informed consent form.

MeSH Terms

Conditions

Sarcoma, Ewing

Condition Hierarchy (Ancestors)

Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Central Study Contacts

Lu Xie, M.D.

CONTACT

+8613401044719; xie.lu@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)