Prospective Evaluation of Dynamic Serum ProGRP for Treatment Response Monitoring in Ewing Sarcoma
2026년 7월 21일 업데이트: 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.
연구 개요
상태
모병
정황
상세 설명
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.
연구 유형
관찰
등록 (추정된)
100
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Lu Xie, M.D.
- 전화번호: +8613401044719
- 이메일: xie.lu@hotmail.com
연구 장소
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Beijing, 중국
- 모병
- Peking University People's Hospital, Beijing, Beijing 100044
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연락하다:
- Lu Xie, M.D.
- 전화번호: +8613401044719
- 이메일: xie.lu@hotmail.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Correlation Between the Change in Serum ProGRP and the Change in Tumor Size
기간: From baseline to completion of neoadjuvant chemotherapy before definitive local treatment, approximately 4 to 6 months
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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.
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From baseline to completion of neoadjuvant chemotherapy before definitive local treatment, approximately 4 to 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Accuracy of Early Change in Serum ProGRP for Predicting Objective Radiographic Response
기간: From baseline to the pre-local-treatment assessment, approximately 4 to 6 months
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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.
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From baseline to the pre-local-treatment assessment, approximately 4 to 6 months
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Objective Response Rate Before Definitive Local Treatment
기간: At completion of neoadjuvant chemotherapy before definitive local treatment, approximately 4 to 6 months after baseline
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Percentage of participants achieving complete response or partial response according to RECIST version 1.1 at the T2 assessment.
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At completion of neoadjuvant chemotherapy before definitive local treatment, approximately 4 to 6 months after baseline
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Longitudinal Change in Serum ProGRP
기간: Baseline through the first post-local-treatment follow-up visit, approximately 7 to 9 months
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Serum ProGRP concentration in pg/mL and its percentage change from baseline will be summarized at T1, T2, and T3.
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Baseline through the first post-local-treatment follow-up visit, approximately 7 to 9 months
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Event-free Survival
기간: From initiation of first-line systemic treatment through 2 years
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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.
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From initiation of first-line systemic treatment through 2 years
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 9월 1일
기본 완료 (추정된)
2026년 9월 1일
연구 완료 (추정된)
2026년 9월 1일
연구 등록 날짜
최초 제출
2026년 7월 21일
QC 기준을 충족하는 최초 제출
2026년 7월 21일
처음 게시됨 (실제)
2026년 7월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 21일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PKUPH-sarcoma 26
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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