Klinikai vizsgálat a Gyomorrák, Gastrooesophagealis junction rák - Klinikai vizsgálatok nyilvántartása

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Részletes leírás

Patients may withdraw from the study at any time at their own request, or they may be withdrawn at any time at the discretion of the Investigator or AstraZeneca.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

Tanulmány típusa

Megfigyelő

Beiratkozás (Becsült)

300

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Név: AstraZeneca Clinical Study Information Center
Telefonszám: 1 877-240-9479
E-mail: information.center@astrazeneca.com

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

Felnőtt
Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

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.

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Csoportok/kohorszok száma

1

Kohorszok és beavatkozások

Csoport / Kohorsz
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.

Csoport / Kohorsz

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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő	Intézkedés leírása	Időkeret
Distribution of GC/GEJ cancer types Időkeret: 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. Időkeret: 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. Időkeret: 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 Időkeret: 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) Időkeret: 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) Időkeret: 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. Időkeret: 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). Időkeret: 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) Időkeret: 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 Időkeret: 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. Időkeret: Up to 18 months ± 30 days (through study completion)	To describe treatment sequences.	Up to 18 months ± 30 days (through study completion)

Másodlagos eredményintézkedések

Eredménymérő	Intézkedés leírása	Időkeret
Pathologic complete response (pCR) rate Időkeret: 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). Időkeret: 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. Időkeret: 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. Időkeret: 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). Időkeret: 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)

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

AstraZeneca

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. szeptember 30.

Elsődleges befejezés (Becsült)

2027. december 31.

A tanulmány befejezése (Becsült)

2027. december 31.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. augusztus 24.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 31.

Első közzététel (Tényleges)

2026. szeptember 2.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. szeptember 2.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 31.

Utolsó ellenőrzés

2026. július 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

D133HR00065

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

IGEN

IPD terv leírása

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 megosztási időkeret

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-megosztási hozzáférési feltételek

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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Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

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