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NCT Number: NCT07800754

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

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.

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Key information

Conditions

Gastric Cancer Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Gastroesophageal Junction Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Stomach Diseases Stomach Neoplasms

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Observational

About this study

Patients may withdraw from the study at any time at their own request, or they may be withdrawn at any time at the discretion of the Investigator or AstraZeneca.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Distribution of GC/GEJ cancer types

    Time frame: Measured at baseline, during patients 1st visit.

    Percentage of GC/GEJ cancer types (adenocarcinoma, squamous cell carcinoma, other).

  2. Clinicopathological characteristics of patients with histologically confirmed stage II to IVB gastric/GEJ cancer.

    Time frame: 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.

  3. To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma.

    Time frame: 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

  4. To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma, measured as frequencies per stage

    Time frame: 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.

  5. Estimation of key time intervals, measured by time (months) from diagnosis to neoadjuvant or perioperative treatment and/or surgery (if applicable)

    Time frame: 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).

  6. Estimation of key time intervals, measured by time (months) from surgery to adjuvant systemic treatment (for Stage II-IVA)

    Time frame: 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)

  7. Estimation of key time intervals, measured by time (months) from first to second-line.

    Time frame: 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.

  8. Estimation of key time intervals, measured by time (months) from second-line to third-line systemic treatment (for Stage IVB).

    Time frame: 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).

  9. Duration of each systemic treatment line (overall and by type: chemotherapy, targeted therapy/immunotherapy; up to 3rd line)

    Time frame: 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)

  10. Description of dosing schemes

    Time frame: 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.

  11. To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma.

    Time frame: Up to 18 months ± 30 days (through study completion)

    To describe treatment sequences.

Secondary outcomes

  1. Pathologic complete response (pCR) rate

    Time frame: 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.

  2. Description of types of biomarkers tested at diagnosis, by disease stage (II-IVA, IVB).

    Time frame: 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).

  3. Percentage of patients tested for biomarkers.

    Time frame: 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.

  4. Percentage of positive results by biomarker type.

    Time frame: 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.

  5. Time from diagnosis to biomarker results captured during biomarkers testing by disease stage (II-IVA, IVB).

    Time frame: 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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: GRACE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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