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

July 21, 2026 updated by: Xie Lu, Peking University People's Hospital
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Patients with newly diagnosed, histologically confirmed Ewing sarcoma who are scheduled to initiate first-line systemic treatment at Peking University People's Hospital will be prospectively enrolled. Treatment selection, including chemotherapy, surgery, and radiotherapy, will be determined by the treating physicians according to routine clinical practice and will not be assigned by the study protocol.

Peripheral blood samples will be collected before the initiation of chemotherapy (T0), after the second or third cycle of neoadjuvant chemotherapy and before the next cycle (T1), after completion of planned neoadjuvant chemotherapy and before definitive local treatment (T2), and at the first routine follow-up visit after surgery or radiotherapy (T3). If longitudinal surveillance is included in the final protocol, additional samples will be collected during routine follow-up.

Serum ProGRP will be measured using an electrochemiluminescence immunoassay. Radiographic response will be assessed according to RECIST version 1.1 by two independent radiologists blinded to the ProGRP results. Disagreements will be resolved by a third reviewer.

The primary analysis will evaluate the correlation between the percentage change in serum ProGRP from T0 to T2 and the percentage change in the sum of diameters of RECIST target lesions over the same period. Secondary analyses will evaluate early prediction of objective response, longitudinal ProGRP patterns, and associations with event-free survival.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University People's Hospital, Beijing, Beijing 100044
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of Early Change in Serum ProGRP for Predicting Objective Radiographic Response
Time Frame: From baseline to the pre-local-treatment assessment, approximately 4 to 6 months
Receiver operating characteristic analysis will be used to evaluate whether the percentage change in serum ProGRP from T0 to T1 predicts objective radiographic response at T2. Objective response is defined as complete response or partial response according to RECIST version 1.1. The area under the receiver operating characteristic curve and its 95% confidence interval will be reported.
From baseline to the pre-local-treatment assessment, approximately 4 to 6 months
Objective Response Rate Before Definitive Local Treatment
Time Frame: At completion of neoadjuvant chemotherapy before definitive local treatment, approximately 4 to 6 months after baseline
Percentage of participants achieving complete response or partial response according to RECIST version 1.1 at the T2 assessment.
At completion of neoadjuvant chemotherapy before definitive local treatment, approximately 4 to 6 months after baseline
Longitudinal Change in Serum ProGRP
Time Frame: Baseline through the first post-local-treatment follow-up visit, approximately 7 to 9 months
Serum ProGRP concentration in pg/mL and its percentage change from baseline will be summarized at T1, T2, and T3.
Baseline through the first post-local-treatment follow-up visit, approximately 7 to 9 months
Event-free Survival
Time Frame: From initiation of first-line systemic treatment through 2 years
Event-free survival is defined as the time from initiation of first-line systemic treatment to the first occurrence of disease progression, local recurrence, a new metastatic lesion, or death from any cause. Participants without an event will be censored at the date of their last confirmed event-free assessment.
From initiation of first-line systemic treatment through 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

July 21, 2026

First Submitted That Met QC Criteria

July 21, 2026

First Posted (Actual)

July 24, 2026

Study Record Updates

Last Update Posted (Actual)

July 24, 2026

Last Update Submitted That Met QC Criteria

July 21, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKUPH-sarcoma 26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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