NCT05606094Befejeződött
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)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2023. dec. 15.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 450 (tényleges)
- Első benyújtás
- 2022. okt. 18.
- Kezdés
- 2023. márc. 9.
- Elsődleges befejezés
- 2023. nov. 30.
- Fő szponzor
- Daiichi Sankyo Co., Ltd.
- Betegségek
- Gyomor- és nyelőcsőrák
- NCT-szám
- NCT05606094
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 450
- 2023. márc. 9. és az elsődleges befejezés (2023. nov. 30.) között
- 31 helyszín, 4 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Más betegség
- 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.
Egyéb
- 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.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (31)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Sichuan Cancer Hospital | Chengdu | Kína | Ismeretlen állapot |
| Sun Yat-Sen University Cancer Center | Guangdong | Kína | Ismeretlen állapot |
| The First Affiliated Hospital of Anhui Medical University | Hefei | Kína | Ismeretlen állapot |
| Hubei Cancer Hospital | Hubei | Kína | Ismeretlen állapot |
| Shanghai Changhai Hospital | Shanghai | Kína | Ismeretlen állapot |
| Tianjin Medical University Hospital | Tianjin | Kína | Ismeretlen állapot |
| Second Affiliated Hospital ZheJiang University School of Medicine | Zhejiang | Kína | Ismeretlen állapot |
| Henan Cancer Hospital | Zhengzhou | Kína | Ismeretlen állapot |
| Queen Mary Hospital | Pok Fu Lam | Hongkong | Ismeretlen állapot |
| Prince of Wales Hospital | Shatin | Hongkong | Ismeretlen állapot |
| Tuen Mun Hospital | Tuenmen | Hongkong | Ismeretlen állapot |
| Dong-A University Hospital | Busan | Dél-Korea | Ismeretlen állapot |
| Chungbuk National University Hospital | Cheongju-si | Dél-Korea | Ismeretlen állapot |
| Kyungpook National University Chillgok Hospital | Deagu | Dél-Korea | Ismeretlen állapot |
| Pusan National University Yangsan Hospital | Gyeongsangnam-do | Dél-Korea | Ismeretlen állapot |
| Samsung Medical Center | Seoul | Dél-Korea | Ismeretlen állapot |
| Chung ang University Hospital | Seoul | Dél-Korea | Ismeretlen állapot |
| Kangbuk Samsung Hospital | Seoul | Dél-Korea | Ismeretlen állapot |
| Korea University Anam Hospital | Seoul | Dél-Korea | Ismeretlen állapot |
| Severance hospital | Seoul | Dél-Korea | Ismeretlen állapot |
| Seoul National University Hospital | Seoul | Dél-Korea | Ismeretlen állapot |
| Chiayi Chang Gung Memorial Hospital | Chiayi City | Tajvan | Ismeretlen állapot |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | Tajvan | Ismeretlen állapot |
| Kaohsiung Medical University Hospital | Kaohsiung City | Tajvan | Ismeretlen állapot |
| China Medical University Hospital | Taichung | Tajvan | Ismeretlen állapot |
| National Cheng Kung University Hospital | Tainan | Tajvan | Ismeretlen állapot |
| Chi Mei Medical Center | Tainan | Tajvan | Ismeretlen állapot |
| Taipei Veterans General Hospital | Taipei | Tajvan | Ismeretlen állapot |
| Koo Foundation Sun Yat-Sen Cancer Center | Taipei | Tajvan | Ismeretlen állapot |
| MacKay Memorial Hospital | Taipei | Tajvan | Ismeretlen állapot |
| Linkou Chang Gung Memorial Hospital | Taoyuan | Tajvan | Ismeretlen állapot |
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