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NCT05606094Completed

Real-World Observational Study to Describe Treatment Patterns in Patients With HER2-Positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer in East Asia

A Multinational, Multicenter, Non-Interventional, Retrospective, Observational, Real-World Study: Treatment Patterns in Patients With HER2-Positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in East Asia (HER2+ GASTA Study)

Source: ClinicalTrials.gov · Last updated 15 Dec 2023

Brief summary (registry, in English)

This study will be conducted to understand real-world treatment patterns, participant characteristics (demographic and clinico-pathological characteristics), clinical outcomes and safety of different treatment regimens, and healthcare resource utilization in East Asia for HER2-positive locally advanced or metastatic gastric or gastroesophageal adenocarcinoma (de novo advanced disease, relapsed/progressed) in a real-world setting.

Status (registry)
Completed
Study type
Observational
Enrollment
450 (actual)
First submitted
18 Oct 2022
Start date
9 Mar 2023
Primary completion date
30 Nov 2023
Lead sponsor
Daiichi Sankyo Co., Ltd.
NCT number
NCT05606094

What you commit to

  • Study type: Observational
  • Participants enrolled: 450
  • From 9 Mar 2023 to the primary completion date, 30 Nov 2023
  • 31 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Participants with a change in HER2 status from positive to negative at progression from early-stage to advanced-stage disease (change from HER2-positive to HER2-negative on repeat biopsy during treatment for advanced stage can be participated). However, if HER2-positive was confirmed before the Date of Diagnosis (or if HER2-positive was confirmed using an archived tumor tissue sample collected during early stage) and the result was followed to make the decision for the 1st LOT, this is not the case.
  • Participants who had multiple cancer within 3 years of 1st LOT initiation (Index Date 1), except adequately resected melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated.

Other

  • Participants who are participating or have participated in an interventional study that remains blinded at time of informed consent (IC) or at the time of data collection for participants whose IC is waived by the local IRB/EC/IEC.

Who the study is looking for

  • Adult participants at the time of 1st LOT (Index Date 1e) initiation - Adult patients ≥18 years old. (Please follow local regulatory requirements if the legal age of consent for study participation is \>18 years old.)
  • Participants or next of kin/legal representatives who are willing to provide written informed consent as per the local regulations (if IRB/IEC/EC grants a permission to waive informed consent, it is not necessary).
  • Participants who were pathologically and/or clinically diagnosed with locally advanced or metastatic gastric or gastroesophageal adenocarcinoma (de novo advanced disease, relapsed/progressed) since January 1, 2016, and its record is available at the study participating site.
  • Participants whose HER2 status were pathologically confirmed HER2-positive (IHC3+ or IHC2+/ISH-positive) before/at the Index Date 2f based on the most recent archived tumor tissue sample to the Date of Diagnosisg, and its record is available at the study participating site.
  • Participants who received at least 1 LOT for HER2-positive locally advanced or mGC/GEJC in an advanced setting, and its record is available at study participating site. Trastuzumab or its biosimilar use is not required.
    • °Progression on or within 6 months post neoadjuvant or adjuvant therapy is counted as "rapid progressor" in a neo-adjuvant/adjuvant setting, and thus equivalent to advanced/metastatic disease failing 1 LOT.
  • Participants who have at least 6 months of follow-up data from the date of 2nd LOT initiation (Index Date 2f) unless participant died within the first 6 months from the Index Date 2, and its record is available at the study participating site.
    • For rapid progressor participants in a neo-adjuvant/adjuvant setting, "Index Date 1" will be the date of neo-adjuvant treatment initiation or adjuvant treatment initiation.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (31)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sichuan Cancer Hospital
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ChengduChinaUnknown status
Sun Yat-Sen University Cancer Center
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GuangdongChinaUnknown status
The First Affiliated Hospital of Anhui Medical University
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HefeiChinaUnknown status
Hubei Cancer Hospital
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HubeiChinaUnknown status
Shanghai Changhai Hospital
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ShanghaiChinaUnknown status
Tianjin Medical University Hospital
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TianjinChinaUnknown status
Second Affiliated Hospital ZheJiang University School of Medicine
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ZhejiangChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
Queen Mary Hospital
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Pok Fu LamHong Kong SAR ChinaUnknown status
Prince of Wales Hospital
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ShatinHong Kong SAR ChinaUnknown status
Tuen Mun Hospital
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TuenmenHong Kong SAR ChinaUnknown status
Dong-A University Hospital
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BusanSouth KoreaUnknown status
Chungbuk National University Hospital
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Cheongju-siSouth KoreaUnknown status
Kyungpook National University Chillgok Hospital
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DeaguSouth KoreaUnknown status
Pusan National University Yangsan Hospital
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Gyeongsangnam-doSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Chung ang University Hospital
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SeoulSouth KoreaUnknown status
Kangbuk Samsung Hospital
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SeoulSouth KoreaUnknown status
Korea University Anam Hospital
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SeoulSouth KoreaUnknown status
Severance hospital
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Chiayi Chang Gung Memorial Hospital
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Chiayi CityTaiwanUnknown status
Kaohsiung Chang Gung Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
Kaohsiung Medical University Hospital
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Kaohsiung CityTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
Chi Mei Medical Center
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TainanTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
Koo Foundation Sun Yat-Sen Cancer Center
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TaipeiTaiwanUnknown status
MacKay Memorial Hospital
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TaipeiTaiwanUnknown status
Linkou Chang Gung Memorial Hospital
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TaoyuanTaiwanUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.