폐 EpiCheck 바이오마커 개발 연구
This study is part of the development of a non-invasive lung cancer screening test which aim to identify early-stage lung cancer in patients at high risk for lung cancer.
연구 개요
상세 설명
This is a prospective, multi-center, observational nonsignificant risk study aimed to collect blood and clinical data from primary lung cancer and control subjects to characterize various biomarkers that will discriminate between lung cancer and control subjects.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Hengelo, 네덜란드
- ZGT Medical Center
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Florida
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Miami, Florida, 미국, 33130
- Life Spring Clinical Research
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Panama City, Florida, 미국, 32405
- Emerald Coast OBGYN
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Louisiana
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Shreveport, Louisiana, 미국, 71106
- Ochsner LSU Health Shreveport - Regional Urology
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Michigan
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Southfield, Michigan, 미국, 48076
- Comprehensive Urology
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Troy, Michigan, 미국, 48084
- Michigan Institute of Urology, P.C.
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Texas
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San Antonio, Texas, 미국, 78229
- Urology San Antonio
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Haifa, 이스라엘
- Carmel Medical Center
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Tel Aviv, 이스라엘
- Sourasky Medical Center
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Budapest, 헝가리
- National Koranyi Institute for Pulmonology
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
All subjects should be without other cancer in the past 5 years except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix
설명
Inclusion Criteria - Cases:
- Age 50-80 years
- Subjects who are currently smoking or former smokers, with at least 20 pack-years
- Subjects with either A high suspicion for lung cancer, with planned biopsy or surgery to establish a definitive diagnosis within 60 days after enrollment or treatment naive lung cancer patients confirmed by pathology.
Exclusion Criteria - Cases
- Known diagnosis or treatment of cancer from any kind in the past 5 years, except of fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix and except from the current lung cancer
Inclusion Criteria - USPSTF risk
- Age 50-80 years
- Subjects who are currently smoking or former smokers, with at least 20 pack-years
Exclusion Criteria - USPSTF risk
- Known diagnosis or treatment of cancer of any kind in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix
Inclusion Criteria - Healthy controls
- Age 20-80 years
- Never smoker or current / previous smoker < 20 pack year history
Exclusion Criteria - Healthy Controls
- Known diagnosis or treatment of cancer of any kind in the past (lifetime), except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix.
- Not previously diagnosed with a lung lesion highly suspicious for cancer
- Under follow up or work up for any lesion suspicious for any type of cancer
- Presenting with fever with body temperature 100.4°F (38°C) or higher
- Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw
- Pregnancy
- Any history of blood product transfusion within 30 days prior to blood draw
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_CONTROL
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Cases Cohort
Subjects age 50-80 years old, with smoking history of at least 20 pack years with either (a) a high suspicion for lung cancer, who are planned to undergo biopsy or surgery to establish a definitive diagnosis after enrollment; or (b) confirmed primary lung cancer diagnosis, treatment naïve subjects. |
Blood collection |
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USPSTF At Risk - Control Cohort
Healthy subjects aged 50-80 years old with smoking history of at least 20 pack years. |
Blood collection |
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Healthy Control Cohort
Healthy subjects aged 20-80 years old which are non-smokers or with smoking history of less than 20 pack years. |
Blood collection |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Performance
기간: Day 1
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Performance of the assay in terms of (1) Sensitivity (2) Specificity (3) NPV (negative predictive value) and (4) PPV (positive predictive value). |
Day 1
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공동 작업자 및 조사자
스폰서
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 (실제)
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. .