- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02907827
Whole-body DW-MRI and cfDNA Analysis for the Surveillance of Melanoma Patients at High Risk for Recurrence. (DW-MRi)
Whole-body Diffusion-weighted Magnetic Resonance Imaging and cfDNA Analysis for the Surveillance of Melanoma Patients at High Risk for Recurrence Following Surgery or Systemic Therapy
연구 개요
상세 설명
Cutaneous melanoma is the most aggressive form of skin cancer. Melanoma is the malignant cancer that originates from the melanocytes of the body (= pigmented cells of the body). Melanoma can originate from the melanocytes that are present in the skin, mucosa, or the uvea of the eye.
The incidence of melanoma is continuing to rise at a rate exceeding all other cancers. Every year approximately 132,000 and 1,000 people will be diagnosed with melanoma and 37,000 and 250 people are expected to die of the disease respectively worldwide and in Belgium. Surgical resection is curative for most cases of early identified and localized melanoma (90% long term survival for stage I disease) . Patients with stage II/III disease are at high risk of relapse after surgery, even when followed by radiotherapy and adjuvant IFN alfa-2b therapy (the risk of recurrence for these patients is 60% to 75%).
In 2010 Romano et al. published a study evaluating the time to relapse and the site of relapse in 340 patients (Figure 1: relapse free survival of all 340 patients with substages IIIA,IIIB and IIIc). Patients and/or family members discovered 62% of local and in-transit recurrences and 49% of nodal recurrences. Only 37% of patients whose first recurrence was systemic detected the recurrence themselves, either by noticing a new tumor or other symptoms that led to further evaluation. Physical examination by a physician accounted for the detection of 36% of the local and in-transit recurrences, Twenty-six percent of nodal recurrences were detected by physicians however only in 9% systemic recurrences did they discover systemic recurrence. In the remaining 63% of patients whose first detectable relapse was systemic, the relapse was asymptomatic. Radiographic tests, largely CT scans (72%), detected asymptomatic systemic relapses in 53% (n_87) of these patients. This study also demonstrated the benefit of identifying early relaps, since symptomatic relapses, as opposed to relapses discovered by physical examination or radiographic imaging, were associated with shorter survival. And confirming that a recurrence that could be completely resected was associated with longer survival (relative risk_2.31; 95% CI, 1.68 to 3.18; P_.001).
In the last several years the therapeutic landscape of melanoma has changed. The introduction of immunotherapy has increased the life expectancy for melanoma stage IV patients and even has the possibility for cure of the disease. This changes the need in screening. Since no therapeutic options were available, there was no need for a strict follow-up. The primary objective of follow-up in these patients with melanoma was to identify potentially curable locoregional recurrences and second primary cancers. Optimal follow-up strategies and intervals have not been determined, and there is no consensus. At a minimum, patients should undergo an annual routine physical examination, including a full skin assessment and palpation of the regional lymph nodes. The role of imaging in the follow-up of high risk patients is not clear. Since the introduction of newer therapies, the need for a more closer follow-up has emerged as well.
The outcome of patients with stage IV disease is grim with less than 50% of patients surviving for more than 12 months. Short-lived tumor responses are obtained in about 10-20% of patients treated with DTIC chemotherapy but no randomized trial could demonstrate a survival benefit for more complex chemotherapy regimens or so-called bio-chemotherapy regimens despite higher response rates.
In march 2011 a CTLA-4 inhibitor, Ipilimumab (Yervoy), was aproved by the FDA. It was the first treatment to prove a survival benefit in melanoma patients. An interesting aspect about the treatment with Ipilimumab is the plateau seen after 2 years.This plateau represents patient with a long term survival benefit of Ipilimumab and even the possibility of 'cure'. The patients in this population now undergo repeated imaging with PET CT and/or CT. This leads to a high radiation burden for this patients. The DW-MRI could in this population have a benefit.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Bart Neyns, MD Phd
- 전화번호: 02 477 60 40
- 이메일: bart.neyns@uzbrussel.be
연구 연락처 백업
- 이름: Yanina JL Jansen, MD
- 전화번호: 02 477 91 23
- 이메일: yanina.jansen@uzbrussel.be
연구 장소
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Brussels, 벨기에, 1090
- 모병
- UZ Brussel
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Brabant
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Jette, Brabant, 벨기에, 1090
- 모병
- UZ Brussel
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically confirmed malignant melanoma;
- AJCC Stage III: No evidence of disease on most recent CT or PET-CT imaging
- Stage IV: Complete remission for more than 3 years, confirmed by most recent CT or PET-CT imaging
Exclusion Criteria:
- Contra-indication for MRI: pacemaker, metallic foreign body in eye, recent operation with prosthetic material (< 6weken)
- Claustrophobia
- Metallic devices implanted such as hip prostheses, since this can alter the imaging quality
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: stage IV melanoma CR>3years
Stage IV: Complete remission for more than 3 years, confirmed by most recent CT or PET-CT imaging
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Whole-body diffusion-weighted magnetic resonance imaging and cfDNA analysis
다른 이름들:
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실험적: Stage III Melanoma
AJCC Stage III: No evidence of disease on most recent CT or PET-CT imaging
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Whole-body diffusion-weighted magnetic resonance imaging and cfDNA analysis
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
explorative evaluation of the use of DWMRI in the follow-up of high risk melanoma patients
기간: 5years
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5years
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2차 결과 측정
결과 측정 |
기간 |
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• Distant metastasis-free survival (for stage III patients only), overall survival
기간: 5years
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5years
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• Registration of the nature and result of salvage therapies offered at the time of detection of recurrence/progression
기간: 5 years
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5 years
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• Explore the correlation of cfDNA measurements and the clinical or MRI based diagnosis of recurrence/progression
기간: 5years
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5years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Bart Neyns, Md Phd, Universitair Ziekenhuis Brussel
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2014-BN-002
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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. .
follow up DW MRI에 대한 임상 시험
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Air Force Military Medical University, China알려지지 않은
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Universitaire Ziekenhuizen KU Leuven알려지지 않은
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Memorial Sloan Kettering Cancer CenterNational Institutes of Health (NIH)모집하지 않고 적극적으로
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American College of Radiology Imaging NetworkNational Cancer Institute (NCI); Eastern Cooperative Oncology Group알려지지 않은
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Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)종료됨
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Fondazione IRCCS Istituto Nazionale dei Tumori,...완전한