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A Study in Greece Observing How Patients With Stomach and Esophageal Cancer Are Diagnosed and Treated in Everyday Medical Practice (GRACE)

2026년 8월 31일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

상세 설명

Patients may withdraw from the study at any time at their own request, or they may be withdrawn at any time at the discretion of the Investigator or AstraZeneca.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.

연구 유형

관찰

등록 (추정된)

300

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: AstraZeneca Clinical Study Information Center
전화번호: 1 877-240-9479
이메일: information.center@astrazeneca.com

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

성인
고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

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 그룹/코호트 생물 의학 또는 건강 결과에 대해 평가되는 관찰 연구의 참가자 그룹 또는 하위 그룹입니다.
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.

그룹/코호트

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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Distribution of GC/GEJ cancer types 기간: Measured at baseline, during patients 1st visit.	Percentage of GC/GEJ cancer types (adenocarcinoma, squamous cell carcinoma, other).	Measured at baseline, during patients 1st visit.
Clinicopathological characteristics of patients with histologically confirmed stage II to IVB gastric/GEJ cancer. 기간: Measured at baseline, during patients 1st visit.	Patient and disease characteristics at diagnosis for patients with histologically confirmed stage II to IVB GC/GEJ adenocarcinoma.	Measured at baseline, during patients 1st visit.
To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma. 기간: Up to 18 months ± 30 days (through study completion)	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	Up to 18 months ± 30 days (through study completion)
To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma, measured as frequencies per stage 기간: Up to 18 months ± 30 days (through study completion)	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.	Up to 18 months ± 30 days (through study completion)
Estimation of key time intervals, measured by time (months) from diagnosis to neoadjuvant or perioperative treatment and/or surgery (if applicable) 기간: Up to 18 months ± 30 days (through study completion)	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).	Up to 18 months ± 30 days (through study completion)
Estimation of key time intervals, measured by time (months) from surgery to adjuvant systemic treatment (for Stage II-IVA) 기간: Up to 18 months ± 30 days (through study completion)	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)	Up to 18 months ± 30 days (through study completion)
Estimation of key time intervals, measured by time (months) from first to second-line. 기간: Up to 18 months ± 30 days (through study completion)	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.	Up to 18 months ± 30 days (through study completion)
Estimation of key time intervals, measured by time (months) from second-line to third-line systemic treatment (for Stage IVB). 기간: Up to 18 months ± 30 days (through study completion)	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).	Up to 18 months ± 30 days (through study completion)
Duration of each systemic treatment line (overall and by type: chemotherapy, targeted therapy/immunotherapy; up to 3rd line) 기간: Up to 18 months ± 30 days (through study completion)	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)	Up to 18 months ± 30 days (through study completion)
Description of dosing schemes 기간: Up to 18 months ± 30 days (through study completion)	To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by describing dosing schemes.	Up to 18 months ± 30 days (through study completion)
To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma. 기간: Up to 18 months ± 30 days (through study completion)	To describe treatment sequences.	Up to 18 months ± 30 days (through study completion)

2차 결과 측정

결과 측정	측정값 설명	기간
Pathologic complete response (pCR) rate 기간: Up to 18 months ± 30 days (through study completion)	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.	Up to 18 months ± 30 days (through study completion)
Description of types of biomarkers tested at diagnosis, by disease stage (II-IVA, IVB). 기간: Up to 18 months ± 30 days (through study completion)	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).	Up to 18 months ± 30 days (through study completion)
Percentage of patients tested for biomarkers. 기간: Up to 18 months ± 30 days (through study completion)	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.	Up to 18 months ± 30 days (through study completion)
Percentage of positive results by biomarker type. 기간: Up to 18 months ± 30 days (through study completion)	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.	Up to 18 months ± 30 days (through study completion)
Time from diagnosis to biomarker results captured during biomarkers testing by disease stage (II-IVA, IVB). 기간: Up to 18 months ± 30 days (through study completion)	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.	Up to 18 months ± 30 days (through study completion)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AstraZeneca

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 (추정된)

2026년 9월 30일

기본 완료 (추정된)

2027년 12월 31일

연구 완료 (추정된)

2027년 12월 31일

연구 등록 날짜

최초 제출

2026년 8월 24일

QC 기준을 충족하는 최초 제출

2026년 8월 31일

처음 게시됨 (실제)

2026년 9월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 31일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

D133HR00065

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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 공유 액세스 기준

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .