再設計された外科用切除鏡装置を使用した膀胱腫瘍の一括経尿道切除術 (En-bloc TURBT) 標本
再設計された外科用切除鏡装置を使用した膀胱腫瘍の一括経尿道切除術 (En-bloc TURBT) 標本の生体外試験
Background:
Bladder cancer is the sixth most common cancer in the United States. The way that doctors remove tumors in bladder surgeries may leave some cancer . Also, many people have their tumors return or progress after surgery. Researchers want to test a modified device. It might tell doctors more about bladder tumors.
Objective:
To see if using a modified standard device with bladder surgery can provide better information about tumors in bladder specimens.
Eligibility:
People ages 18 and older who need to have their bladder removed at the NIH.
Design:
Participants will be screened with:
Medical and prior surgical history
Review of existing MRI, x-ray, or CT scans
Review of existing specimens and reports
Pregnancy test for women of childbearing age
CT or MRI: Participants will lie in a machine. The machine will take pictures of their body.
Participants will have bladder surgery. This will occur in the same way as if they did not take part in this study. A member of the research team will cut the removed bladder using the modified device. This will most likely be done on a separate back table in the operating room. The bladder and samples after cutting will be sent out for review. The will occur just as it would if the participants were not in this study. The only difference is the way that the specimen is prepared for review.
Participants follow-up care will occur per standard of care. Or it will occur as part of any other study in which they might also be enrolled.
調査の概要
詳細な説明
Background:
- Bladder cancer is the sixth most common cancer in the United States, disproportionately affecting more men than women.
- The gold standard for the surgical treatment and diagnosis of non-muscle invasive bladder cancer is transurethral resection of bladder tumors (TURBT).
- TURBT requires the fragmentation of bladder tumors and piecemeal removal of these tumors.
- TURBT leads to loss of histopathologic information - including tumor orientation, size, and margin status - which may compromise outcomes and risk tumor seeding within the bladder.
- Given these multiple problems with TURBT we are testing some modifications to the current resectoscope device and the effect of these modifications on the quality of TURBT specimens produced.
- The redesigned resectoscope device will be tested ex-vivo on cystectomy specimens to avoid risks to patient safety.
Objectives:
The primary objective of this study is to determine if resectoscope device modification can provide improved pathologic standards for the TURBT procedure. An improvement in any of the parameters outlined below will constitute a device improvement in the current resectoscope:
- Presence of three tissue layers within the tumor specimens containing bladder mucosa, lamina propria, and portions of the muscularis.
- Information regarding tumor margin, assessed as the ability to ascertain if tumor is present at the margin of the resection.
Eligibility:
- Medical condition requiring surgical removal of the bladder
- Men and women, age >= 18 years
Design:
- Preclinical tissue acquisition trial, ex vivo, proof-of-concept.
- Following cystectomy, a modified resectoscope/redesigned resectoscope will be used to resect areas of tumor from the cystectomy specimens. These resected tumors will be sent with the cystectomy specimen for histopathology to assess the size of resection, depth of resection, and ability to ascertain tumor orientation.
- The remainder of the cystectomy specimens will undergo traditional histopathology. Histopathologic information from both specimens will be included in the final histopathologic diagnosis to ensure accurate oncology staging.
- This study will allow for about 2 years of accrual and the accrual ceiling will be set at 25 subjects.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：NCI Medical Oncology Referral Office
- 電話番号：(240) 760-6050
- メール：ncimo_referrals@nih.gov
研究連絡先のバックアップ
- 名前：Raju R Chelluri, M.D.
- 電話番号：(240) 858-3700
- メール：raju.chelluri@nih.gov
研究場所
-
-
Maryland
-
Bethesda、Maryland、アメリカ、20892
- 募集
- National Institutes of Health Clinical Center
-
コンタクト：
- For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
- 電話番号：888-624-1937
-
-
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
サンプリング方法
調査対象母集団
Bladder Cancer Patients
説明
- INCLUSION CRITERIA:
- Patients requiring surgical removal of the bladder at the NIH Clinical Center.
NOTE: Reasons for need for surgical removal of bladder include cancer or benign condition for which a surgeon determined surgical removal of the bladder is recommended. Patient's with invasive bladder cancer requiring cystectomy are eligible for enrollment. Bladder cancer remains the most common reason for cystectomy. Patients with clinical advanced disease and having other treatments/or participating in other trials remain eligible for enrollment in this study.
- Men and women
- Age greater than or less than 18 years
- Deemed clinically appropriate for the planned surgical procedure.
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Subjects will be asked to co-enroll in 15-C-0087, "Care of the Urothelial Cancer Patient and Prospective Collection of Biospecimens from Healthy Volunteers and Urothelial Cancer Patients." NOTE: Most participants are expected to already be enrolled in 15-C-0087 prior to entry in this study.
EXCLUSION CRITERIA:
- Cystectomy during pregnancy would subject the fetus to significant risk of miscarriage or premature labor. For this reason, pregnant women are ineligible for this study.
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
1/ Cohort 1
Bladder Cancer Patients |
The modified resectoscope will be used post cystectomy (En-bloc TURBT) to resect areas of the tumor from the cystectomy specimen. These resected tumors will be sent for histopathology to assess the size of resection, depth of resection, and ability to ascertain tumor orientation and compared to the remainder of the cystectomy specimens to see if the modified resectoscope can provide improved pathologic standards for the TURBT procedure. All patients will receive routine surgical transurethral resection of bladder tumors (TURBT). |
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 |
|---|---|---|
|
Assessment of resectoscope device modification on pathologic standards for the TURBT procedure
時間枠：Time of surgery/pathologic assessment (7-10 days)
|
-Presence of three tissue layers with in the tumor specimens containing bladder mucosa, lamina propria, and portions of the muscularis.-Information regarding tumor margin, assessed as the ability to ascertain if tumor is present at the margin of the resection. |
Time of surgery/pathologic assessment (7-10 days)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Assessment for possible bladder perforation in bladder specimens
時間枠：Time of surgery/pathologic assessment (7-10 days)
|
The rate of occurrence will be described/tabulated. |
Time of surgery/pathologic assessment (7-10 days)
|
協力者と研究者
捜査官
- 主任研究者：Raju R Chelluri, M.D.、National Cancer Institute (NCI)
出版物と役立つリンク
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 200020
- 20-C-0020
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
All IPD recorded in the medical record will be shared with intramural investigators upon request.
IPD 共有時間枠
Clinical data available during the study and indefinitely.
IPD 共有アクセス基準
Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。