- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02149576
Does Intense Regimented Surveillance Improve the Rates of Therapeutic Re-Intervention After Lung Cancer Surgery (Intense-CT)
Does Intense Regimented Surveillance Improve the Rates of Therapeutic Re-Intervention After Lung Cancer Surgery: A Pilot Study for the Intense-CT Trial
After curative lung cancer surgery, there is a risk of recurrence of the primary cancer, or development of a new cancer. Historically, patients who have undergone curative lung cancer surgery have been monitored with chest radiographs (CXR). Unfortunately, 70% of such patients still die of lung cancer. As a result, there has been interest in other methods of surveillance in order to detect recurring or new cancers earlier and have more success in treating them. One such technique is Low Dose Computed Tomography (LDCT), which is currently the standard of care and surveillance at this institution. This pilot study aims to determine whether regimented, intensive, short interval LDCT surveillance leads to higher rates of detection and treatment of recurring lung cancers. The study group will be followed up according to a regimented surveillance program using LDCT. The study group will be compared to a group of historical controls whose follow up after surgery was not standardized, but rather left up to the discretion of the individual surgeon. If the results of this study show improvements in detection and treatment of recurrent cancers, it will allow for a larger trial to study the effects of the LDCT surveillance program on lung cancer survival.
The study question aims to determine whether for survivors after curative surgery for Stage I and Stage II lung cancer, a structured Surveillance Program with Low Dose CT can increase the rate of detection and treatment of recurring or new cancers when compared to historical non-structured surveillance with CXR. This study will also determine if it is warranted to pursue a larger scale randomized controlled trial to further investigate optimal LDCT surveillance follow-up intervals and long-term lung cancer survival.
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Ontario
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Hamilton, Ontario, 캐나다, L8N 4A6
- St. Joseph's Healthcare Hamilton
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients must be at minimum 18 years of age
- Patients must have undergone complete resection for pathological Stage I or Stage II lung cancer
- Patients must demonstrate the ability to understand English
- Patients must be able to demonstrate aptitude and willingness to comply with describes study procedures
Exclusion Criteria:
- Patients with residual gross or microscopic disease after surgery
- Patients with pathological Stage III or Stage IV lung cancer
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: LDCT Surveillance Program Group
This cohort will follow a strict schedule of Low Dose Computed Tomography Imaging scans and clinical visits 3, 6, and 12 months after surgery.
At each encounter, a history, physical examination, and review of the LDCT results will be performed.
Patients with normal clinical and imaging findings will proceed to the next scheduled clinical encounter.
Patients with abnormal findings will be managed according to predetermined algorithms.
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다른: Historical Control Group
The control group will be a retrospective cohort taken from 1-year before the implementation of the LDCT surveillance program.
The post-operative follow-up of these participants was not standardized, but rather left up to the discretion of the individual surgeons, and involved chest radiograph imaging as opposed to Low Dose Computed Tomography.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Rate of therapeutic re-intervention within the first year after curative resection of lung cancer
기간: One year after surgery
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Defined by: 1) rate of curative intent radiation treatment after detection of recurrent or new primary lung cancer 2) rate of curative intent reoperation after detection of recurrent or new primary lung cancer.
Measured by frequency of events.
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One year after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Rate of adherence to follow-up visits
기간: One year after surgery
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Measured by frequency of events
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One year after surgery
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Morbidity of associated interventions
기간: One year after surgery
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Measured by frequency of events
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One year after surgery
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공동 작업자 및 조사자
수사관
- 수석 연구원: Wael C Hanna, MDCM MBA FRCSC FCCP, McMaster University
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 연구와 관련된 용어
기타 연구 ID 번호
- SJHH_IntenseCT_Pilot
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .
폐 신생물에 대한 임상 시험
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Novartis Pharmaceuticals완전한신경내분비종양 | GI 오리진의 고급 NET | 고급 NET of Lung Origin미국, 콜롬비아, 이탈리아, 대만, 영국, 벨기에, 체코, 독일, 일본, 사우디 아라비아, 캐나다, 네덜란드, 스페인, 대한민국, 레바논, 오스트리아, 중국, 그리스, 남아프리카, 태국, 헝가리, 칠면조, 폴란드, 슬로바키아, 러시아 연방
Low Dose Computed Tomography Imaging에 대한 임상 시험
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Istituto Ortopedico Rizzoli모집하지 않고 적극적으로
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HeartFlow, Inc.Case Western Reserve University완전한
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Lithuanian University of Health SciencesHacettepe University; University of Michigan; University of Messina; Universidad de Granada알려지지 않은