Prospective Evaluation of Dynamic Serum ProGRP for Treatment Response Monitoring in Ewing Sarcoma
2026年7月21日 更新者：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.
調査の概要
状態
募集
条件
詳細な説明
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.
研究の種類
観察的
入学 (推定)
100
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Lu Xie, M.D.
- 電話番号：+8613401044719
- メール：xie.lu@hotmail.com
研究場所
-
-
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Beijing、中国
- 募集
- Peking University People's Hospital, Beijing, Beijing 100044
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コンタクト：
- Lu Xie, M.D.
- 電話番号：+8613401044719
- メール：xie.lu@hotmail.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Correlation Between the Change in Serum ProGRP and the Change in Tumor Size
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Accuracy of Early Change in Serum ProGRP for Predicting Objective Radiographic Response
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年9月1日
一次修了 (推定)
2026年9月1日
研究の完了 (推定)
2026年9月1日
試験登録日
最初に提出
2026年7月21日
QC基準を満たした最初の提出物
2026年7月21日
最初の投稿 (実際)
2026年7月24日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月24日
QC基準を満たした最後の更新が送信されました
2026年7月21日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。