- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02671422
LUME BioNIS: a Biomarker Study in Patients With NSCLC
A Non-interventional Biomarker Study in Patients With Non-Small Cell Lung Cancer (NSCLC) of Adenocarcinoma Tumour Histology Eligible for Treatment With Vargatef® According to the Approved Label.
연구 개요
상태
정황
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Athens, 그리스, 11527
- Athens Hospital of Chest Dis.
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Heraklion, 그리스, 71110
- University General Hospital of Heraklion
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Thessaloniki, 그리스, 555 35
- European Interbalkan Medical Centre
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Amsterdam, 네덜란드, 1091 AC
- OLVG, locatie Oosterpark
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EDE, 네덜란드, 6716 RP
- Ziekenhuis Gelderse Vallei
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Groningen, 네덜란드, 9728 NT
- Martini Ziekenhuis
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Harderwijk, 네덜란드, 3844 DG
- Sint Jansdal Ziekenhuis
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Hengelo, 네덜란드, 7555DL
- Ziekenhuisgroep Twente locatie Hengelo
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Hilversum, 네덜란드, 1213 XZ
- Tergooi Ziekenhuis
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Rotterdam, 네덜란드, 3079 DZ
- Maasstad Ziekenhuis
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Herlev, 덴마크, 2730
- Herlev and Gentofte Hospital
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Bremen, 독일, 28325
- Gesundheit Nord gGmbH | Klinikverbund Bremen
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Düsseldorf, 독일, 40489
- Florence-Nightingale-Krankenhaus der Kaiserswerther Diakonie
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Großhansdorf, 독일, 22927
- Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
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Kaiserslautern, 독일, 67655
- Onkologische Schwerpunktpraxis
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Löwenstein, 독일, 74245
- Klinik, Löwenstein
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Münnerstadt, 독일, 97702
- Thoraxzentrum Bezirk Unterfranken
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Nürnberg, 독일, 90419
- Klinikum Nürnberg
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Oldenburg, 독일, 26121
- Pius-Hospital, Oldenburg
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Saarbrücken, 독일, 66113
- Caritas Klinik St. Theresia; Saarbrücken
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Völklingen, 독일, 66333
- SHG-Kliniken Völklingen
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Luxembourg, 룩셈부르크, 1210
- Luxembourg - HOSP CH de Luxembourg
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Kaunas, 리투아니아, LT-50009
- Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos
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Vilnius, 리투아니아, 08660
- National Cancer Institute, Vilnius
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Bruxelles, 벨기에, 1200
- Brussels - UNIV Saint-Luc
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Gent, 벨기에, 9000
- AZ Maria Middelares
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Gent, 벨기에, 9000
- AZ Sint-Lucas - Campus Sint Lucas
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Ieper, 벨기에, 8900
- Ieper - HOSP Jan Yperman
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Liège, 벨기에, 4000
- Liège - HOSP CHR de la Citadelle
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Lodelinsart, 벨기에, 6042
- Charleroi - UNIV CHU de Charleroi
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Roeselare, 벨기에, 8800
- Roeselare - HOSP AZ Delta
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Gävle, 스웨덴, 801 87
- Gävle Sjukhus
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Linköping, 스웨덴, 581 85
- Universitetssjukhuset, Linköping
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Stockholm, 스웨덴, 171 76
- Karolinska Univ. sjukhuset
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Uppsala, 스웨덴, 751 85
- Akademiska Sjukhuset
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Alicante, 스페인, 03010
- Hospital General Universitario de Alicante
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Buegos, 스페인, 09006
- Hospital Universitario de Burgos
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Girona, 스페인, 17007
- Hospital Universitari de Girona Doctor Josep Trueta
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Jaén, 스페인, 23007
- Complejo Hospitalario de Jaén
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Las Palmas de Gran Canaria, 스페인, 35016
- Complejo Hospitalario Universitario Insular - Materno Infantil
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Leganes - Madrid, 스페인, 28911
- Hospital Severo Ochoa
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León, 스페인, 24008
- Hospital de Leon
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Lugo, 스페인, 27003
- Hospital Universitario Lucus Augusti
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Madrid, 스페인, 28040
- Hospital Clinico San Carlos
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Madrid, 스페인, 28046
- Hospital La Paz
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Mataró, 스페인, 08304
- Hospital de Mataro
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Palma de Mallorca, 스페인, 07010
- Hospital Son Espases
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Pamplona, 스페인, 31008
- Complejo Hospitalario de Navarra
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Sabadell, 스페인, 08208
- CS Parc Taulí
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Santander, 스페인, 39008
- Hospital Universitario Marques de Valdecilla
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Sevilla, 스페인, 41013
- Hospital Virgen del Rocío
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Sevilla, 스페인, 41071
- Hospital Virgen Macarena
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Terrassa, 스페인, 08227
- Consorci Sanitari de Terrassa - Hospital de Terrassa
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Valencia, 스페인, 46015
- Hospital Arnau de Vilanova
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Valladolid, 스페인, 47005
- Hospital Clínico Universitario de Valladolid
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Aberdeen, 영국, AB25 2ZN
- Aberdeen Royal Infirmary
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Bebington, Wirral, 영국, CH63 4JY
- Clatterbridge Cancer Centre
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Bury St Edmunds, 영국, IP33 2QZ
- West Suffolk Hospital
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Exeter, 영국, EX2 5DW
- Royal Devon and Exeter Hospital
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Ipswich, 영국, IP4 5PD
- Ipswich Hospital
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Keighley, 영국, BD20 6TD
- Airedale General Hospital
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Middlesbrough, 영국, TS4 3BW
- James Cook University Hospital
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Newcastle Upon Tyne, 영국, NE7 7DN
- Freeman Hospital
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Plymouth, 영국, PL6 8DH
- Derriford Hospital
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Krems, 오스트리아, 3500
- LK Krems
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Wien, 오스트리아, 1090
- AKH - Medical University of Vienna
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Alessandria, 이탈리아, 15100
- Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo
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Palermo, 이탈리아, 90146
- Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
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Budapest, 헝가리, 1121
- National Koranyi TBC and Pulm. Internal Med. Clinic
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Matrahaza, 헝가리, 3233
- Lung Hospital of Matra, Dept. Pulmonology
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Miskolc, 헝가리, 3526
- BAZ County Central Hospital and University Teaching Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion criteria:
- Age = 18 years.
- Women and men with locally advanced, metastatic or locally recurrent NSCLC with histology of adenocarcinoma.
- Signed and dated written informed consent.
- Vargatef ® is initiated and administered in accordance with the SPC.
- Available fixed and paraffin embedded (FPE) tumour tissue routinely obtained at diagnosis and/or at re-biopsy before the initiation of the first line treatment (either block or slides, minimum of 10 slides and up to 20 slides if possible at 5µm thickness).
Exclusion criteria:
- Any contraindication to Vargatef® or docetaxel as specified in their respective labels.
- Vargatef® initiated more than 7 days prior to inclusion in this NIS.
- Patients participating simultaneously in a clinical trial.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of Participants With Overall Survival (OS) Event
기간: From start of entering the study until death or last contact date, up to 42 months.
|
Overall survival (OS) was defined as the time from start of entering the study to time of death. For the analysis of overall survival, participants were censored at the date of the last contact if the physician was no longer able to contact a participants or caregiver, and the vital status could not otherwise be determined. Enrolled participants who never received the combination therapy of docetaxel and Vargatef® were censored on the day of enrolment. Calculation of OS: For participants with known date of death: OS [days] = date of death - date of treatment start + 1 For participants known to be alive by the end of the study or at follow-up visit: OS (censored) [days] = date of last contact when the Patient was known to be alive - date of treatment start + 1. |
From start of entering the study until death or last contact date, up to 42 months.
|
공동 작업자 및 조사자
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
암종, 비소세포폐에 대한 임상 시험
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