A Study in Greece Observing How Patients With Stomach and Esophageal Cancer Are Diagnosed and Treated in Everyday Medical Practice (GRACE)
maanantai 31. elokuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Yksityiskohtainen kuvaus
Patients may withdraw from the study at any time at their own request, or they may be withdrawn at any time at the discretion of the Investigator or AstraZeneca.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.
Opintotyyppi
Havainnollistava
Ilmoittautuminen (Arvioitu)
300
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: AstraZeneca Clinical Study Information Center
- Puhelinnumero: 1 877-240-9479
- Sähköposti: information.center@astrazeneca.com
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Näytteenottomenetelmä
Ei-todennäköisyysnäyte
Tutkimusväestö
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.
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
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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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Distribution of GC/GEJ cancer types
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
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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.
Aikaikkuna: 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.
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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).
Aikaikkuna: 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)
Aikaikkuna: 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)
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Up to 18 months ± 30 days (through study completion)
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Description of dosing schemes
Aikaikkuna: 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.
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Pathologic complete response (pCR) rate
Aikaikkuna: 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).
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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).
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Keskiviikko 30. syyskuuta 2026
Ensisijainen valmistuminen (Arvioitu)
Perjantai 31. joulukuuta 2027
Opintojen valmistuminen (Arvioitu)
Perjantai 31. joulukuuta 2027
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Maanantai 24. elokuuta 2026
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Maanantai 31. elokuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Keskiviikko 2. syyskuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Keskiviikko 2. syyskuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Maanantai 31. elokuuta 2026
Viimeksi vahvistettu
Keskiviikko 1. heinäkuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- D133HR00065
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
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-jaon aikakehys
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-jaon käyttöoikeuskriteerit
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.
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
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