An interventional study of No-touch laparoscopic radical nephrectomy and Conventional laparoscopic radical nephrectomy in Renal Cell Carcinoma and Circulating Tumor Cell, sponsored by Hospital de Santa Maria, Portugal. Completed at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-14.
Sponsored by Hospital de Santa Maria, Portugal · Not applicable, Interventional, and Treatment
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.
This study will study CTC profile in RCC, and their release into the blood circulation during LRN.
Included patients will be referred to the Renal Cancer Unit of the North Lisbon University Hospital Center (CHLUN) Urology Department with the diagnosis of a renal mass eligible for a LRN. Patients will have their diagnosis confirmed, be appropriately staged, and their management options will be decided after a shared and informed decision process in light of the current European Association of Urology (EAU) Guidelines on RCC. Patients \< 18 years old and pregnant women will be excluded. Patients will be adequately informed of the study protocol, and will sign a specific informed consent.
Patients undergoing LRN will enter a two-arm prospective single-center randomized controlled trial, comparing a no-touch technique, with direct pedicle ligation (Group A) vs. the conventional dissection, and ligation of the renal pedicle with kidney traction (Group B). A peripheral blood sample will be collected at arrival to the operating room. After that, Group A patients will undergo a no-touch RN, 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. Group B patients will undergo a more conventional 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. A second peripheral blood sample will be collected at the time of specimen extraction. A third and fourth peripheral blood samples will be collected at post-operative days 1 and 30, respectively, to study CTC post-op kinetics. All samples will collect 7.5 mL of peripheral blood.
Patients presenting with hypofunctioning kidneys with indication for total nephrectomy will be used as controls. Total nephrectomy patients will undergo the randomization protocol, in a control arm.
The CTCs will be isolated from peripheral blood samples using a microfluidics size-based CTC capture device - Ruby™. Whole blood samples will be injected into the devices at an 80 µL/min flow rate. The CTCs captured on the devices will then be stained with antibodies to 4',6-diamidino-2-phenylindole (DAPI) to identify cell nuclei, cluster of differentiation antigen 45 (CD45) to identify leukocytes, cytokeratin 8/18 to identify epithelial CTCs, and vimentin to identify mesenchymal CTCs or CTCs which have undergone epithelial-to-mesenchymal transition. Blood samples will be processed no more than 30 minutes after collection.
2,037 studies on the registry are indexed under Carcinoma, Renal Cell; 395 are open to participants now.
This study's enrollment of 44 is close to the median of 43 across 1,564 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Hospital de Santa Maria, Portugal is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
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Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group 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.
Procedure: No-touch laparoscopic radical nephrectomy
Group 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.
Procedure: Conventional laparoscopic radical nephrectomy
Control arm in which a laparoscopic total nephrectomy will be performed in patients with hypo-functioning kidneys, and no renal cell carcinoma.
Procedure: Laparoscopic total nephrectomy control arm
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.
Circulating tumor cell count - intra-operative
CTC count in peripheral blood after tumor specimen extraction
Time frame: Intra-operative
Circulating tumor cell count - D1
CTC count in peripheral blood at post-operative day 1
Time frame: Post-operative day 1
Circulating tumor cell count - D30
CTC count in peripheral blood at post-operative day 30
Time frame: Post-operative day 30
Overall survival
Overall survival
Time frame: 3 year
Disease free survival
Disease free survival
Time frame: 3 year
Ran from Sep 2021 to primary completion in May 2022, 7 months.
Of 119 non-industry interventional studies with no phase under Carcinoma, Renal Cell, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 114. This study's 7 months is below that.
Counting every sponsor, half of 126 studies reached it within 45 months; a quarter within 22 and three quarters within 114.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Hospital de Santa Maria, Portugal