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

21. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

100

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
      • Beijing, Kina
        • Rekruttering
        • Peking University People's Hospital, Beijing, Beijing 100044
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Correlation Between the Change in Serum ProGRP and the Change in Tumor Size
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Accuracy of Early Change in Serum ProGRP for Predicting Objective Radiographic Response
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Peking University People's Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. september 2025

Primær fullføring (Antatt)

1. september 2026

Studiet fullført (Antatt)

1. september 2026

Datoer for studieregistrering

Først innsendt

21. juli 2026

Først innsendt som oppfylte QC-kriteriene

21. juli 2026

Først lagt ut (Faktiske)

24. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PKUPH-sarcoma 26

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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