Клинические исследование Рак желудка, Рак желудочно-пищеводного соединения - Реестр клинических исследований

Обзор исследования

Статус

Еще не набирают

Условия

Подробное описание

Patients may withdraw from the study at any time at their own request, or they may be withdrawn at any time at the discretion of the Investigator or AstraZeneca.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

Тип исследования

Наблюдательный

Регистрация (Оцененный)

300

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Имя: AstraZeneca Clinical Study Information Center
Номер телефона: 1 877-240-9479
Электронная почта: information.center@astrazeneca.com

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

Взрослый
Пожилой взрослый

Принимает здоровых добровольцев

Нет

Метод выборки

Невероятностная выборка

Исследуемая популяция

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.

Описание

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.

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Количество групп / когорт

1

Когорты и вмешательства

Группа / когорта
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.

Группа / когорта

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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Distribution of GC/GEJ cancer types Временное ограничение: 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. Временное ограничение: 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. Временное ограничение: 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 Временное ограничение: 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) Временное ограничение: 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) Временное ограничение: 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. Временное ограничение: 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). Временное ограничение: 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) Временное ограничение: 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 Временное ограничение: 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. Временное ограничение: Up to 18 months ± 30 days (through study completion)	To describe treatment sequences.	Up to 18 months ± 30 days (through study completion)

Вторичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Pathologic complete response (pCR) rate Временное ограничение: 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). Временное ограничение: 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. Временное ограничение: 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. Временное ограничение: 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). Временное ограничение: 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)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

AstraZeneca

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

30 сентября 2026 г.

Первичное завершение (Оцененный)

31 декабря 2027 г.

Завершение исследования (Оцененный)

31 декабря 2027 г.

Даты регистрации исследования

Первый отправленный

24 августа 2026 г.

Впервые представлено, что соответствует критериям контроля качества

31 августа 2026 г.

Первый опубликованный (Действительный)

2 сентября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

2 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

31 августа 2026 г.

Последняя проверка

1 июля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

D133HR00065

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

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.

Сроки обмена IPD

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.

Критерии совместного доступа к IPD

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.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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Epidemiological Characteristics And Management Strategies Of Gastric/Gastrophaegal Junction Cancer Patients In Routine Clinical Practice: A Greek Multicenter Observational Study (The GRACE Study)