상부 요로상피세포암종에 대한 림프절 절제술 유무에 관계없이 신장 절제술
상부 요로상피세포암종에 대한 림프절 절제술 유무에 따른 신장 절제술의 종양학적 및 수술 전후 결과를 조사하는 무작위 대조 시험
The goal of this study is to conduct the first randomized-controlled trial to determine the oncologic efficacy of lymph node dissection in participants with upper tract urothelial cell carcinoma. The main questions it aims to answer are:
- To determine oncologic outcomes, specifically 2-year recurrence-free survival
- To determine other oncologic outcomes including treatment-free, cancer-specific and overall survival
- To determine time to recurrence and recurrence patterns
- To determine use of adjuvant therapies
- To determine perioperative complications
Participants will undergo nephroureterectomy with or without lymph node dissection. Researchers will compare these two groups to determine the oncologic efficacy of performing lymph node dissection.
연구 개요
상세 설명
Upper Tract Urothelial Carcinoma (UTUC) is a rare disease with complex management. Some participants with clinically negative nodes may still receive a lymph node dissection (LND) with nephroureterectomy, and currently, no randomized controlled trial exists to evaluate the oncologic efficacy of this practice. According to current American Urologic Association guidelines, Nephroureterectomy is the standard of care intervention for high-risk UTUC and low-risk UTUC is endoscopically unresectable. The aim of the present study is to determine the efficacy, specifically 2-year recurrence-free survival, of lymph node dissection at time of nephroureterectomy for participants with UTUC, compared to no lymph node dissection, as well as examine other oncologic outcomes and complication rates
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Mohamed Eltemamy, MD
- 전화번호: 216-444-5888
- 이메일: Eltemam@ccf.org
연구 연락처 백업
- 이름: Rebecca Campbell, MD
- 전화번호: 216-444-1105
- 이메일: CAMPBER7@ccf.org
연구 장소
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Florida
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Gainesville, Florida, 미국, 32209
- 모병
- University of Florida Health Science Center
-
연락하다:
- Tarik Benidir, MD
-
부수사관:
- Tarik Benidir, MD
-
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Illinois
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Springfield, Illinois, 미국, 62702
- 모병
- Southern Illinois University
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연락하다:
- Mohammad Mahmoud, MD
- 이메일: mmahmoud96@siumed.edu
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수석 연구원:
- Mohammad Mahmoud, MD
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Ohio
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Cleveland, Ohio, 미국, 44195
- 모병
- Cleveland Clinic Glickman Urological and Kidney Institute
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연락하다:
- Mohamed Eltemamy, MD
- 전화번호: 216-444-5888
- 이메일: Eltemam@ccf.org
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Cleveland, Ohio, 미국, 44106
- 모병
- University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center
-
연락하다:
- Adam Calaway, MD, MPH
- 이메일: Adam.Calaway@UHhospitals.org
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수석 연구원:
- Adam Calaway, MD, MPH
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adults > 18 years
- Diagnosis of UTUC as determined by upper tract biopsy (either low or high grade)
- Planned for nephroureterectomy by their urologic surgeon
- Disease that is ≤cT4, N0M0. Participants must have complete TNM staging prior to surgery. cT disease can be determined by biopsy of the mass (if biopsy was deep enough) or imaging (CT/MRI). cN and cM stage must be determined by preoperative imaging of the chest, abdomen and pelvis.
- No concomitant muscle-invasive bladder cancer
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Pathologically enlarged lymph nodes suspicious for metastases which would require lymph node dissection regardless of trial (>cN0)
- Presence of distant metastases
- Concomitant muscle invasive bladder cancer
- The participant is in a reduced general condition or has a life-threatening disease.
- The participant has a psychiatric disorder that precludes them from understanding the consent process.
- The patient is pregnant
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Nephroureterectomy With Lymph Node Dissection
Participants will undergo nephroureterectomy for UTUC and will receive LND. |
Participants will undergo standard-of-care nephroureterectomy for UTUC. Participants will receive lymph node dissection alongside nephroureterectomy for UTUC. |
|
활성 비교기: Nephroureterectomy Without Lymph Node Dissection
Participants will undergo nephroureterectomy for UTUC and will not receive LND. |
Participants will undergo standard-of-care nephroureterectomy for UTUC. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Recurrence-free survival
기간: 2 years post-op
|
Kaplan-Meier will compare recurrence-free survival time between participants who received LND vs participants who did not receive LND. |
2 years post-op
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Treatment-free survival
기간: 2 years post-op
|
Kaplan-Meier will compare treatment-free survival time between participants who received LND vs participants who did not receive LND. |
2 years post-op
|
|
Cancer-specific survival
기간: 2 years post-op
|
Kaplan-Meier will compare cancer-specific survival time between participants who received LND vs participants who did not receive LND. |
2 years post-op
|
|
Overall Survival
기간: 2 years post-op
|
Kaplan-Meier will compare the overall survival between participants who received LND vs participants who did not receive LND. |
2 years post-op
|
|
Time to recurrence
기간: 2 years post-op
|
Kaplan-Meier will compare the time to disease recurrence between participants who received LND vs participants who did not receive LND. |
2 years post-op
|
|
Use of adjuvant therapies
기간: 2 years post-op
|
T-test or the Wilcoxon rank-sum test will be applied to determine the rate of adjuvant therapies used between participants who received LND vs participants who did not receive LND. |
2 years post-op
|
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Perioperative complications
기간: 2 years post-op
|
T-test or the Wilcoxon rank-sum test will be applied to determine the rate of perioperative complications between participants who received LND vs participants who did not receive LND. |
2 years post-op
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Mohamed Eltemamy, MD, Cleveland Clinic, Glickman Urological and Kidney Institute, Case Comprehensive Cancer Center
- 수석 연구원: Adam Calaway, MD, MPH, University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- CASE2824
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
This will be shared via a redcap database. All of the variables listed in the PRMC protocol and IRB application will be shared.
IPD 공유 기간
From when the trial starts (receives IRB approval and recruitment is initiated) until 1 year after the final participant finishes 2 year follow-up.
IPD 공유 액세스 기준
This will be shared with the following people at UH PI, research coordinator, residents/fellows/other attendings who are included on the IRB at UH.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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