요로상피암 환자의 예후 바이오마커
2021년 4월 29일 업데이트: Hellenic Cooperative Oncology Group
백금 요법으로 치료한 요로상피암 환자의 예후 바이오마커 조사
방광암(BC)은 결과가 좋지 않은 이질적인 악성 종양입니다. 치료에도 불구하고 MIBC의 5년 전체 생존율은 <50%이며, 많은 환자가 반응이 없거나 부적절하여 치료에 가장 반응하거나 적합할 가능성이 높은 환자를 선택하기 위한 바이오마커가 필요합니다.
연구 개요
상태
완전한
정황
상세 설명
이 연구에서는 전체 생존(OS) 측면에서 가장 빈번하게 돌연변이된 유전자와 임상병리학적 특징 사이의 연관성, 그리고 상위 돌연변이 및 DNA 손상 반응(DDR) 돌연변이 유전자의 돌연변이 존재의 예후적 중요성을 평가했습니다.
또한 전체 종양 침윤 림프구(TIL) 밀도를 측정하고 PD-L1, 4개의 MMR 단백질(MLH1, MSH2, MSH6 및 PMS2) 및 종양 또는 간질 CD8+ 세포독성 T 림프구 침윤물의 발현을 면역조직화학적으로 분석하고 이들과의 연관성을 평가했습니다. 예후에서의 역할과 함께 상위 돌연변이 유전자 및 이용 가능한 임상병리학적 매개변수.
연구 유형
관찰
등록 (실제)
66
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
이것은 백금 요법으로 치료받은 요로상피암 환자의 생체 샘플을 사용한 다국적 분석입니다.
환자들은 Hellenic Cooperative Oncology Group(HeCOG) 소속 종양학과에서 치료를 받았습니다.
설명
포함 기준:
- 방광에 위치한 요로상피암
- 신보조제에서 백금 요법으로 치료받은 환자. 보조 설정
- 생물학적 물질 사용에 대한 서면 동의서
제외 기준:
-
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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요로상피암 환자의 돌연변이 프로파일 평가
기간: 최대 5년
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최대 5년
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2차 결과 측정
결과 측정 |
기간 |
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PD-L1 발현과 돌연변이 프로파일의 연관성
기간: 최대 5년
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최대 5년
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전체 생존에 대한 돌연변이의 예후적 중요성의 연관성
기간: 최대 5년
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최대 5년
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2000년 5월 1일
기본 완료 (실제)
2017년 3월 1일
연구 완료 (실제)
2017년 6월 1일
연구 등록 날짜
최초 제출
2021년 4월 29일
QC 기준을 충족하는 최초 제출
2021년 4월 29일
처음 게시됨 (실제)
2021년 5월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 5월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 4월 29일
마지막으로 확인됨
2021년 4월 1일
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. .
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