Neoplasms

All Conditions

Symptoms and General Pathology

Blood and Lymph Conditions

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Hypertrophy

Lymphadenopathy

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

Template-based LND was carried out in all patients in this group. The anatomical extent of LND is described in previous study. Lymph node specimens were sampled "en bloc" with surrounding adipose tissue, and were sent to pathological examination as individual packets with the surrounding adipose tissue.

LND was carried out only in patients who have lymph nodes enlargement in preoperative imaging (CTU or enhanced MRI) or who were found lymph nodes enlargement during surgery.

Routine Template-based lymphadenectomy

LND was carried out only in patients who have lymph nodes enlargement in preoperative imaging (e.g. CTU or enhanced MRI) or who were found lymph nodes enlargement during surgery

LND only for lymph nodes enlargement found in preoperative image or during surgery

jiwei huang, M.D.

Xuesong Li, M.D

Jiwei Huang, M.D

Wei Xue, M.D

Liqun Zhou, M.D

Recent studies showed the therapeutic benefit of lymphadenectomy in advanced stage urothelial carcinoma of the upper urinary tract, but there is still a lack of prospective studies. Thus, the current guideline recommends lymph node dissection for invasive upper tract urothelial carcinoma (UTUC) on the basis of insufficient evidence. Also, the preoperative judgment of muscle invasive pathological stage T 2+,or N+ is difficult from preoperative imaging. In the investigators' clinical practice, the surgeons performed dissection of regional lymph nodes only in patients with enlargement of lymph nodes found in preoperative imaging or during surgery. The aim of this multi-institutional study was to examine the role of lymphadenectomy in urothelial carcinoma of the upper urinary tract.

Prognostic Value of Lymph Node Dissection in Patients With Transitional Cell Carcinoma of the Upper Urinary Tract

Prospective Randomized Phase II Trial: Comparing the Prognostic Value of Routine Lymphadenectomy Versus Lymphadenectomy Only for Lymph Nodes Enlargement Found in Preoperative Imaging or During Surgery Undergoing Nephroureterectomy in Patients With Primary Upper Tract Urothelial Carcinoma

Disease free survival rate in the 36 month following nephroureterectomy

Cancer specific survival rate in the 36 month following nephroureterectomy

Overall survival rate in the 36 month following nephroureterectomy

The recurrence rate of bladder cancer in the 36 month following nephroureterectomy

Perioperative complications were evaluated up to 90 days after surgery, and were graded by Clavien-Dindo classiﬁcation

Peking University First Hospital

RenJi Hospital

Transitional Cell Cancer of the Renal Pelvis and Ureter

A single 1300 nm OCT measurement will be performed during ureterorenoscopy in patients with upper urinary tract tumour(s)

Single Optical Coherence Tomography measurement of upper urinary tract tumour taken during ureterorenoscopy

Optical Coherence Tomography

Jean J. de la Rosette, MD PhD

The purpose of this study is to establish in vivo sensitivity and specificity of OCT in the diagnosis of Upper Urinary Tract Urothelial Carcinoma.

Minimal invasive endoscopic treatment for Upper Urinary Tract Urothelial Carcinoma (UUT-UC) has been accepted as a treatment option instead of radical nephroureterectomy for patients with low grade, low stage disease. For this reason, information on tumour stage and grade is important for a clinical decision. Until now,diagnostic ureterorenoscopy combined with histology/cytology is the gold standard. Unfortunately, histology/cytology is often inconclusive.

Optical Coherence Tomography is a new high resolution imaging technique that has potential to provide the urologist real time per-operative information of grade and stage of the disease.

In this study the investigators aim to establish in vivo sensitivity and specificity of OCT in the diagnosis of Upper Urinary Tract Urothelial Carcinoma. Secondary objectives are inter-observer variability of 1300 nm OCT in the diagnosis of UUT-UC and optical properties of cancerous and healthy ureter and collecting system tissue in vivo in humans.

Diagnostic Accuracy of Optical Coherence Tomography in Upper Urinary Tract Urothelial Carcinoma

a Prospective In-vivo Human Study to Assess the Diagnostic Accuracy of Optical Coherence Tomography for Diagnosis and Staging of Upper Urinary Tract Urothelial Carcinoma

only a single OCT measurement will be done during surgery. This measurement will take a maximum of 10 minutes, including preparation of the OCT device

Only a single OCT measurement will be done during surgery. This measurement will take a maximum of 10 minutes, including preparation of the OCT device

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

M.D.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Urologic Diseases

A prospective single-arm two-stage phase II study to allow for analysis of the treatment-specific outcomes and disease-specific survival of patients treated with open or laparoscopic nephroureterectomy and bladder cuff excision along with a lymph node dissection (modified template retroperitoneal lymph node dissection).

The lymph nodes will be sent to pathology for review.

Lymph Node Dissection

Philippe Spiess, M.D.

The primary objective is to show that performing a lymph node dissection may detect occult nodal metastasis in this patient population whereby providing important diagnostic information, with potential therapeutic benefits in patients with isolated nodal metastases.

In case of urothelial carcinoma of the upper urinary tract (a cancer originating from the inner lining of the urinary tract) requiring the removal of the kidney, ureter, and cuff of bladder (a surgical termed a nephroureterectomy). Previous studies in urothelial carcinoma of the bladder, have shown that doing a lymph node dissection (surgically removing the lymph nodes) may improve survival, or at least give an idea of what patients may need chemotherapy (drugs to control the cancer cells that are outside the kidney-ureter) earlier (before the nodes are enlarged in the imaging studies).

Participants will have a nephroureterectomy (taking the kidney and the ureter). Investigators will also be doing a lymph node dissection (taking the patient's lymph nodes in the same side of the kidney) to look for malignancy outside of the kidney and ureter. The lymph nodes will be sent to pathology for review.

Study visits will be scheduled 10 to 14 days after surgery for removal of stitches and analysis of the patient's pathology report.

The following procedures will be done:

* History and physical examination, urinary cytology (test to look for malignant cells in the urine) and surveillance cystoscopy (procedure to look inside the urethra and bladder which is performed in the office under local anesthesia) every 3 months for the first 2 years after treatment, every 6 months for the next 2 years and yearly thereafter if the patient is free from recurrence.
* Radiographic studies including chest x-ray and abdomino-pelvic computed tomography (CAT scans) will be performed every 6 months for the first 2 years and then yearly thereafter.
* Bone scan (special imaging study to look for cancer spread in bone) in case of bone pain or elevated alkaline phosphatase level.

After surgery patients will be followed every 3 months for the first 2 years after treatment, every 6 months for the next 2 years and yearly thereafter if they are free from recurrence.

Merits of Performing a Modified Template Retroperitoneal Lymph Node Dissection

Merits of Performing a Modified Template Retroperitoneal Lymph Node Dissection at Time of Nephroureterectomy for Urothelial Carcinoma of the Upper Urinary Tract

The number of participants having pathologically proven lymph node metastasis at the time of radical nephroureterectomy (RNU) and modified retroperitoneal lymph node dissection (RPLND).

The primary endpoint is the detection via lymph node dissection of pathological node positive urothelial carcinoma in patients treated with open or laparoscopic nephroureterectomy for upper tract urothelial cancer.

The mean (range) total lymph node count and lymph node count per procedure category. Between 2009 and 2011, patients with suspected upper urinary tract urothelial carcinoma (UUT-UC) underwent open, laparoscopic, or robot-assisted radical nephroureterectomy (RNU) with modified retroperitoneal lymph node dissection (RPLND).

H. Lee Moffitt Cancer Center and Research Institute

A prospective single-arm two-stage phase II study to allow for analysis of the treatment-specific outcomes and disease-specific survival of patients treated with open or laparoscopic nephroureterectomy and bladder cuff excision along with a lymph node dissection (modified template retroperitoneal lymph node dissection).

Lymph Node Dissection : The lymph nodes will be sent to pathology for review.

Lymph Node Dissection at Time of Nephroureterectomy

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

The sample size was small because it was a single institution study. It was thus underpowered to achieve a cancer-specific endpoint pertaining to the oncological merit of performing a modified RPLND in the context of UUT-UC.

Philippe E. Spiess, M.D.

All evaluable participants. On histopathological review, one patient had a benign angioma and was excluded from the final data analysis.

Number of Participants With Pathologically Proven Lymph Node Metastasis

Total Lymph Node Count for All Participants

Total Lymph Node Count

Lymph Node Count for Open RNU Procedure Group

Open RNU Lymph Node Count

Lymph Node Count for Laparoscopic RNU Procedure Group

Laparoscopic RNU Lymph Node Count

Lymph Node Count for Robot-assisted RNU Procedure Group

Robot-assisted RNU Lymph Node Count

Total Participants and Participants Per Procedure Category

Surgical Outcomes: Mean Lymph Node Count

Overall Study

All patients will receive enfortumab vedotin at 1.25 g/kg on days 1 and 8 of 21 days cycle, for a total of three cycles, followed by radical nephroureterectomy, ureterectomy, or nephrectomy, depending on the site of the tumor and per the clinical decision of the treating urologist.

All patients will receive enfortumab vedotin at 1.25 mg/kg on days 1 and 8 of 21 days cycle, for a total of three cycles.

Enfortumab Vedotin

Radical surgery, such as radical nephroureterectomy, nephrectomy or ureterectomy is to take place within 60 days from the last dose of treatment end of cycle 3 (i.e., cycle 3 day 22).

Radical surgery

Min Yuen Teo, MD

Jonathan Rosenberg, MD

The purpose of this study is to find out whether the study drug, enfortumab vedotin, is an effective and safe treatment for people who have urothelial carcinoma of the upper urinary tract. Study participants will be people who are not eligible to receive or have chosen not to receive the chemotherapy drug cisplatin for treatment of their cancer. In addition, all participants will be planning on having standard surgery to remove their tumor.

A Study of Enfortumab Vedotin in People With Urothelial Carcinoma of the Upper Urinary Tract

Neoadjuvant Enfortumab Vedotin in High-Grade Urothelial Carcinoma of the Upper Urinary Tract (Including Ureter and Renal Pelvis)

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

The absence of residual disease on pathologic evaluation on surgical specimen following neoadjuvant enfortumab vedotin for UTUC. Pathologists will assess surgical specimens systematically using criteria agreed upon for all conventional neoadjuvant treatment based on the AJCC TNM staging system.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prognostic Value of Lymph Node Dissection in Patients With Transitional Cell Carcinoma of the Upper Urinary Tract	NCT03474926	Lymph Node Diss...	Routine Templat... LND only for ly...	15 Years - 80 Years	RenJi Hospital
Diagnostic Accuracy of Optical Coherence Tomography in Upper Urinary Tract Urothelial Carcinoma	NCT02326909	Transitional Ce...	Optical Coheren... Optical Coheren...	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Merits of Performing a Modified Template Retroperitoneal Lymph Node Dissection	NCT00751140	Cancer of the U...	Lymph Node Diss...	-	H. Lee Moffitt Cancer Center and Research Institute
A Study of Enfortumab Vedotin in People With Urothelial Carcinoma of the Upper Urinary Tract	NCT05868265	Urothelial Carc...	Enfortumab Vedo... Radical surgery	18 Years -	Memorial Sloan Kettering Cancer Center
Merits of Performing a Modified Template Retroperitoneal Lymph Node Dissection	NCT00751140	Cancer of the U...	Lymph Node Diss...	-	H. Lee Moffitt Cancer Center and Research Institute
Prognostic Value of Lymph Node Dissection in Patients With Transitional Cell Carcinoma of the Upper Urinary Tract	NCT03474926	Lymph Node Diss...	Routine Templat... LND only for ly...	15 Years - 80 Years	RenJi Hospital

Spots Global Cancer Trial Database for upper urinary tract