Circulating Tumor Cell Reducing No-touch Nephrectomy
CITO-CERENE
No-touch Radical Nephrectomy Technique Reduces Circulating Tumor Cell Release in Renal Cell Carcinoma Patients - a Randomized Controlled Trial
1 other identifier
interventional
44
1 country
1
Brief Summary
This study will study circulating tumor cell (CTC) release during laparoscopic radical nephrectomy (LRN) for RCC. The main objective is to determine if CTC release can be reduced during RN by using a no-touch technique, with an early renal pedicle ligation. The investigators also aim to describe the CTC profile in terms of CTC count (CTCn), epithelial/mesenchymal status, and CTC cellular features in renal cell carcinoma (RCC) patients, stratified by "primary tumor, regional nodes, metastasis" (TNM) staging, histological subtype, and other clinical and radiological features. Patients undergoing RN will enter a two-arm prospective single-center randomized controlled trial (RCT), comparing a no-touch RN technique, with direct pedicle ligation (Group A) vs. the more conventional approach of kidney traction and manipulation to reach the renal pedicle before its ligation (Group B). A microfluidic size-based CTC isolation device will be used to capture and count CTCs from peripheral blood samples of these patients. CTCs will be identified by staining with antibodies to cytokeratin 8/18, vimentin, 4',6-diamidino-2-phenylindole (DAPI), and cluster of differentiation antigen 45 (CD45). CTC release will be correlated with the disease-free survival (DFS), and overall survival (OS). The investigators will determine if CTC reducing no-touch radical nephrectomy technique improves these hard outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2021
CompletedStudy Start
First participant enrolled
September 27, 2021
CompletedFirst Posted
Study publicly available on registry
October 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2022
CompletedNovember 14, 2022
November 1, 2022
8 months
September 26, 2021
November 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Circulating tumor cell count - intra-operative
CTC count in peripheral blood after tumor specimen extraction
Intra-operative
Circulating tumor cell count - D1
CTC count in peripheral blood at post-operative day 1
Post-operative day 1
Circulating tumor cell count - D30
CTC count in peripheral blood at post-operative day 30
Post-operative day 30
Secondary Outcomes (2)
Overall survival
3 year
Disease free survival
3 year
Study Arms (3)
No-touch laparoscopic radical nephrectomy
EXPERIMENTALGroup A patients will undergo a no-touch laparoscopic radical nephrectomy, with the dissection being done through the Gerota's fascia plane until exposure of the corresponding great vessel (vena cava on the right side, and aorta on the left side) is obtained. The renal pedicle will be directly isolated, and ligated using Weck® clips with no kidney manipulation.
Conventional laparoscopic radical nephrectomy
ACTIVE COMPARATORGroup B patients will undergo a conventional laparoscopic radical nephrectomy approach, starting with opening of the Gerota's fascia, identification of the ureter, traction on the peri-renal fat below the ureter while dissecting cephalad until the renal pedicle is reached. The renal pedicle will then be isolated while maintaining traction on the kidney, and peri-renal fat, and ligated using Weck® clips.
Laparoscopic total nephrectomy control arm
OTHERControl arm in which a laparoscopic total nephrectomy will be performed in patients with hypo-functioning kidneys, and no renal cell carcinoma.
Interventions
We aim to determine if a laparoscopic no-touch nephrectomy with an early renal pedicle ligation can decrease CTC release during surgery.
Conventional laparoscopic radical nephrectomy, which implies manipulation of the kidney, opening of the Gerota's fascia, and manipulation of peri-nephric fat during dissection, and renal pedicle isolation.
Control arm in which a laparoscopic total nephrectomy will be performed in non-cancer patients.
Eligibility Criteria
You may qualify if:
- Renal mass on renal imaging compatible with kidney cancer
- Indication for laparoscopic radical nephrectomy
You may not qualify if:
- History of other cancer (carcinoma)
- Previous systemic therapy for renal cell carcinoma
- human immunodeficiency virus (HIV) positive
- Hepatitis C virus (HCV) positive
- hepatitis B virus (HBV) positive
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital de Santa Maria, Portugallead
- Instituto de Medicina Molecular João Lobo Antunescollaborator
- Centro Hospitalar Lisboa Nortecollaborator
Study Sites (1)
Urology Department - Hospital de Santa Maria
Lisbon, Lisbon District, 1649-035, Portugal
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tito P Leitão, MD
Faculdade de Medicina da Universidade de Lisboa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 26, 2021
First Posted
October 7, 2021
Study Start
September 27, 2021
Primary Completion
May 18, 2022
Study Completion
May 18, 2022
Last Updated
November 14, 2022
Record last verified: 2022-11