上部尿路上皮細胞癌に対するリンパ節郭清を伴うおよび伴わない腎尿管切除術
上部尿路上皮細胞癌に対するリンパ節郭清を伴う場合と伴わない腎尿管切除術の腫瘍学的および周術期の転帰を検討するランダム化対照試験
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.
調査の概要
詳細な説明
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
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Mohamed Eltemamy, MD
- 電話番号：216-444-5888
- メール：Eltemam@ccf.org
研究連絡先のバックアップ
- 名前：Rebecca Campbell, MD
- 電話番号：216-444-1105
- メール：CAMPBER7@ccf.org
研究場所
-
-
Florida
-
Gainesville、Florida、アメリカ、32209
- 募集
- University of Florida Health Science Center
-
コンタクト：
- Tarik Benidir, MD
-
副調査官：
- Tarik Benidir, MD
-
-
Illinois
-
Springfield、Illinois、アメリカ、62702
- 募集
- Southern Illinois University
-
コンタクト：
- Mohammad Mahmoud, MD
- メール：mmahmoud96@siumed.edu
-
主任研究者：
- Mohammad Mahmoud, MD
-
-
Ohio
-
Cleveland、Ohio、アメリカ、44195
- 募集
- Cleveland Clinic Glickman Urological and Kidney Institute
-
コンタクト：
- Mohamed Eltemamy, MD
- 電話番号：216-444-5888
- メール：Eltemam@ccf.org
-
Cleveland、Ohio、アメリカ、44106
- 募集
- University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center
-
コンタクト：
- Adam Calaway, MD, MPH
- メール：Adam.Calaway@UHhospitals.org
-
主任研究者：
- Adam Calaway, MD, MPH
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
アクティブコンパレータ：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recurrence-free survival
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Treatment-free survival
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
|
Perioperative complications
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Mohamed Eltemamy, MD、Cleveland Clinic, Glickman Urological and Kidney Institute, Case Comprehensive Cancer Center
- 主任研究者：Adam Calaway, MD, MPH、University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- CASE2824
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
This will be shared via a redcap database. All of the variables listed in the PRMC protocol and IRB application will be shared.
IPD 共有時間枠
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 共有アクセス基準
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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