A Study in Greece Observing How Patients With Stomach and Esophageal Cancer Are Diagnosed and Treated in Everyday Medical Practice (GRACE)
2026年8月31日 更新者：AstraZeneca
Epidemiological Characteristics And Management Strategies Of Gastric/Gastrophaegal Junction Cancer Patients In Routine Clinical Practice: A Greek Multicenter Observational Study (The GRACE Study)
This is a retrospective-prospective observational, multicenter, single-country study aiming to describe the epidemiological characteristics and management strategies in patients with stage II-IVB gastric/GEJ adenocarcinoma in routine clinical practice in Greece.
調査の概要
詳細な説明
Patients may withdraw from the study at any time at their own request, or they may be withdrawn at any time at the discretion of the Investigator or AstraZeneca.
In all cases, every reasonable effort should be made to document patient outcome, if applicable.
研究の種類
観察的
入学 (推定)
300
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：AstraZeneca Clinical Study Information Center
- 電話番号：1 877-240-9479
- メール：information.center@astrazeneca.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
- 大人
- 高齢者
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
Approximately 300 adult patients with histologically confirmed, stage II to IVB gastric/GEJ adenocarcinoma will be enrolled from 10-15 oncology clinics of large public and private hospitals, covering diverse geographic areas, in Greece.
説明
Inclusion Criteria:
- Patients aged ≥18 years upon gastric/GEJ adenocarcinoma diagnosis.
- Written signed and dated informed consent by the patient (or their legally acceptable representative, as applicable). For deceased patients on the date of study entry a waiver of consent must be approved by the Hospital EC/IRB.
- Patients diagnosed with histologically confirmed, stage II to IVB adenocarcinoma of gastric/GEJ, between June 1st, 2025 and the end of the recruitment period (Q3 2027).
Exclusion Criteria:
- Patients who participate or participated during the data collection period (prospective and retrospective) in any clinical investigation/clinical trial that includes interventions that fall outside the everyday clinical practice.
- Patients who have participated in the design and/or the conduct of the study.
- Patients with another primary malignancy within the last 5 years, for which systemic anticancer treatment is required after the diagnosis of gastric/GEJ cancer.
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 Stage II-IVB Gastric/GEJ Adenocarcinoma
Adult patients with histologically confirmed, stage II to IVB gastric/GEJ adenocarcinoma will be enrolled from 10-15 oncology clinics of large public and private hospitals, covering diverse geographic areas, in Greece.
Eligible patients will have been diagnosed between June 1st, 2025 and the end of the recruitment period (Q3 2027).
The study includes both retrospective and prospective components.
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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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Distribution of GC/GEJ cancer types
時間枠：Measured at baseline, during patients 1st visit.
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Percentage of GC/GEJ cancer types (adenocarcinoma, squamous cell carcinoma, other).
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Measured at baseline, during patients 1st visit.
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Clinicopathological characteristics of patients with histologically confirmed stage II to IVB gastric/GEJ cancer.
時間枠：Measured at baseline, during patients 1st visit.
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Patient and disease characteristics at diagnosis for patients with histologically confirmed stage II to IVB GC/GEJ adenocarcinoma.
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Measured at baseline, during patients 1st visit.
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To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma.
時間枠：Up to 18 months ± 30 days (through study completion)
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To describe current treatment modalities (surgery, systemic therapy, radiotherapy, chemoradiation (CRT) and palliative care) applied in the resectable (Stages II-IVA) and advanced/metastatic (Stage IVB) settings, presented as types
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Up to 18 months ± 30 days (through study completion)
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To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma, measured as frequencies per stage
時間枠：Up to 18 months ± 30 days (through study completion)
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To describe current treatment modalities (surgery, systemic therapy, radiotherapy, chemoradiation (CRT) and palliative care) applied in the resectable (Stages II-IVA) and advanced/metastatic (Stage IVB) settings, presented as frequencies per stage.
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Up to 18 months ± 30 days (through study completion)
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Estimation of key time intervals, measured by time (months) from diagnosis to neoadjuvant or perioperative treatment and/or surgery (if applicable)
時間枠：Up to 18 months ± 30 days (through study completion)
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To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by estimating key time intervals, including time (months) from diagnosis to neoadjuvant or perioperative treatment and/or surgery (if applicable).
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Up to 18 months ± 30 days (through study completion)
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Estimation of key time intervals, measured by time (months) from surgery to adjuvant systemic treatment (for Stage II-IVA)
時間枠：Up to 18 months ± 30 days (through study completion)
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To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by estimation of key time intervals, including time (months) from surgery to adjuvant systemic treatment (for Stage II-IVA)
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Up to 18 months ± 30 days (through study completion)
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Estimation of key time intervals, measured by time (months) from first to second-line.
時間枠：Up to 18 months ± 30 days (through study completion)
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To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by estimating key time intervals, including time (months) from first to second-line.
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Up to 18 months ± 30 days (through study completion)
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Estimation of key time intervals, measured by time (months) from second-line to third-line systemic treatment (for Stage IVB).
時間枠：Up to 18 months ± 30 days (through study completion)
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To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by estimating key time intervals, including time (months) from second-line to third-line systemic treatment (for Stage IVB).
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Up to 18 months ± 30 days (through study completion)
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Duration of each systemic treatment line (overall and by type: chemotherapy, targeted therapy/immunotherapy; up to 3rd line)
時間枠：Up to 18 months ± 30 days (through study completion)
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To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by estimating the duration of each systemic treatment line (overall and by type: chemotherapy, targeted therapy/immunotherapy; up to 3rd line)
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Up to 18 months ± 30 days (through study completion)
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Description of dosing schemes
時間枠：Up to 18 months ± 30 days (through study completion)
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To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by describing dosing schemes.
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Up to 18 months ± 30 days (through study completion)
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To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma.
時間枠：Up to 18 months ± 30 days (through study completion)
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To describe treatment sequences.
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Up to 18 months ± 30 days (through study completion)
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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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Pathologic complete response (pCR) rate
時間枠：Up to 18 months ± 30 days (through study completion)
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The proportion of patients with stage II-IVA gastric/GEJ adenocarcinoma with no viable tumor cells, including lymph nodes, in the resected gastric specimen after completion of neoadjuvant therapy and surgery.
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Up to 18 months ± 30 days (through study completion)
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Description of types of biomarkers tested at diagnosis, by disease stage (II-IVA, IVB).
時間枠：Up to 18 months ± 30 days (through study completion)
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To evaluate current biomarker testing strategies and patterns among patients with stage II to IVB gastric/GEJ adenocarcinoma, based on information about types of biomarkers tested at diagnosis, by disease stage (II-IVA, IVB).
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Up to 18 months ± 30 days (through study completion)
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Percentage of patients tested for biomarkers.
時間枠：Up to 18 months ± 30 days (through study completion)
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To evaluate current biomarker testing strategies and patterns among patients with stage II to IVB gastric/GEJ adenocarcinoma, based on percentage of patients tested for biomarkers.
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Up to 18 months ± 30 days (through study completion)
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Percentage of positive results by biomarker type.
時間枠：Up to 18 months ± 30 days (through study completion)
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To evaluate current biomarker testing strategies and patterns among patients with stage II to IVB gastric/GEJ adenocarcinoma, based on percentage of positive results by biomarker type.
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Up to 18 months ± 30 days (through study completion)
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Time from diagnosis to biomarker results captured during biomarkers testing by disease stage (II-IVA, IVB).
時間枠：Up to 18 months ± 30 days (through study completion)
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To evaluate current biomarker testing strategies and patterns among patients with stage II to IVB gastric/GEJ adenocarcinoma, based on information on biomarkers testing by disease stage (II-IVA, IVB), including time from diagnosis to biomarker results.
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Up to 18 months ± 30 days (through study completion)
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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。
スポンサー
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 (推定)
2026年9月30日
一次修了 (推定)
2027年12月31日
研究の完了 (推定)
2027年12月31日
試験登録日
最初に提出
2026年8月24日
QC基準を満たした最初の提出物
2026年8月31日
最初の投稿 (実際)
2026年9月2日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月2日
QC基準を満たした最後の更新が送信されました
2026年8月31日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- D133HR00065
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD 共有時間枠
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIPhRMA Data Sharing Principles.
For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD 共有アクセス基準
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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