Carcinoma, Renal CellNCT05589207
Predicting Model Based on Evidence-based Pathological Diagnose Criteria for RCC Tumor Thrombus With IVC Wall Invasion
An observational study of Carcinoma, Renal Cell and Tumor Thrombus, run by Peking University Third Hospital at 1 site in China.
Trial summary
The goal of this observational study is to establish a preoperative imaging diagnostic model which highly consistent with the histopathological examinations, as well as a accurate and systematic pathological grading standard of inferior vena cava (IVC) vascular wall invasion in renal cell carcinoma (RCC) with tumor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell, Tumor Thrombus, Neoplasm Invasiveness
- What is being tested?
- Vascular wall invaded
- How many people
- 232 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The groups of cohort will be selected from inhospital patients in Peking University Third Hospital.
Who may be able to join
- Adults ≥18 years of age;
- Accepted abdominal ultrasonography, contrast-induced ultrasonography, enhanced CT and MRI before the surgery;
- Diagnosis of primary renal cell carcinoma with tumor thrombus before and during the surgery;
- Received radical nephrectomy and at least one kind of thrombectomy (including IVC incision only, IVC partial resection, IVC diagonal resection, and IVC segmental resection)
- Can tolerate the surgery;
- Eastern Cooperative Oncology Group Performance Status Scale (ECOG-PS) 0~2;
- No previous history of malignant tumor;
- Willing to return for required follow-up visits
Who cannot join
- Failed to receive standard nephrectomy for any reason;
- Attached other addition operations in the surgery;
- Received neoadjuvant treatment before the surgery;
- Experience any other conditions that may affect the curative effect (e.g. active tuberculosis, autoimmune disease, or oral glucocorticoids treatment);
- Experience serious consequences or death due to anesthesia accident during operation;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Zhuo Liu, Doctor, +086 15611908062, liuzhuo1990@yeah.net
About this study
Official title: Preoperative Imaging Diagnostic Evaluation Model Based on Evidence-based Pathological Diagnose Criteria for Renal Cell Carcinoma Tumor Thrombus With Inferior Vena Cava Wall Invasion
The goal of this observational study is to establish a preoperative imaging diagnostic model which highly consistent with the histopathological examinations, as well as a accurate and systematic pathological grading standard of inferior vena cava (IVC) vascular wall invasion in renal cell carcinoma (RCC) with tumor thrombus invading vascular wall.The main questions it aims to answer are:
- To establish a preoperative imaging diagnostic model which highly consistent with the histopathological examinations.
- To determine what impact does different vascular wall layer invasion make on the long-term prognosis in RCC with IVC tumor thrombus;
- To determine which layer invasion according to pathological examination make sense to clinical treatment (can significantly affect prognosis); Participants with IVC vascular wall invasion/ non-invasion are divided into experimental group (invaded group) or control group (non-invaded group) respectively according to pathological examinations, in order to establish a prospective cohort with three-year follow-up. The pathological characteristics of local recurrence and poor prognosis are summarized, and postoperative pathological diagnostic criteria of IVC vascular wall invasion and established. The local recurrence and distant recurrence outcomes are compared between experiment group and control group, in order to analyze the long-term influence of vascular wall invasion. Then the preoperative imaging diagnostic evaluation model will be established.
Read the detailed description
Radical nephrectomy and thrombectomy are essential surgical treatments for renal cell carcinoma (RCC) with inferior vena cava (IVC) tumor thrombus. IVC vascular wall invasion leads to higher recurrence risk and worse long-term prognosis. The diagnosis and treatment of RCC tumor thrombus with IVC vascular wall invaded are affected by prominent difficulties: First, there is a lack of the preoperative diagnostic evaluation system consisting to the postoperative histopathological examinations, which is regarded as the gold standard of vascular wall invasion, therefore hinders the development of the neoadjuvant therapy strategy and surgery plan; Besides, the pathological diagnostic criteria of IVC vascular wall adhesion or invasion is inconsistent among different centers, an accurate and systematic criteria is needed.
This study consecutively includes patients admitted in Peking University Third Hospital between January 2023 to January 2026, who were diagnosed with primary renal cell carcinoma with IVC tumor thrombus with/without vascular wall invasion, and accepted radical nephrectomy and at least one IVC thrombectomy (including IVC incision only, IVC partial resection, IVC diagonal resection, and IVC segmental resection). The patients with IVC vascular wall invasion/ non-invasion are divided into experimental group (invaded group) or control group (non-invaded group) respectively according to pathological examinations, in order to establish a prospective cohort with three-year follow-up. For the invaded group, micro invasion subgroup and tumor thrombus capsule subgroup analysis are conducted. The pathological characteristics of local recurrence and poor prognosis are summarized, and postoperative pathological diagnostic criteria of IVC vascular wall invasion and established. The local recurrence and distant recurrences outcomes are compared between experiment group and control group, in order to analyze the long-term influence of vascular wall invasion. Then the preoperative imaging diagnostic evaluation model were established: re-diagnose patients in two groups according to the established pathological diagnostic criteria, and divide them into truly-invaded group and truly-non-invaded group. Analyzing the preoperative abdominal ultrasound scan, contrast-enhanced ultrasonography, computed tomography (CT) and magnetic resonance imaging (MRI), thus explore the imaging characteristics of vascular wall invasion and establish the preoperative diagnostic model. This study aims at establish a preoperative imaging diagnostic model which highly consistent with the histopathological examinations, as well as a accurate and systematic pathological grading standard of IVC vascular wall invasion, therefore contribute to the development of a more accurate and effective preoperative treatment strategy and surgery plan.
- Conditions
- Carcinoma, Renal Cell, Tumor Thrombus, Neoplasm Invasiveness, Inferior Vena Cava Interruption
- Being tested
- Vascular wall invaded
- Keywords
- Neoplasm Grading, Diagnostic Model, Preoperative Diagnosis
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasm Invasiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular wall invadedDiagnostic test
Inferior vena cava vascular wall is invaded according to pathologic examination on the postoperative tumor thrombus/ vascular wall specimen.
| Study group | Role | What they receive |
|---|---|---|
| Invaded Group | Patients whose inferior vena cava vascular wall is invaded according to histopathological examination. Receives: Diagnostic Test: Vascular wall invaded | |
| Non-invaded group | Patients whose inferior vena cava vascular wall is not invaded according to histopathological examination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The duration from the date of diagnosis to death or last follow-up, with no restriction on the cause of death.
Measured: From date of randomization until the date of lost follow-up or date of death from any cause, whichever came first, assessed up to 120 months
Secondary outcomes (24)
Clinical manifestation
Clinical manifestation related to the renal carcinoma
Measured: From the clinical diagnosis until the surgery, an average of 3 weeks
Mayo classification
A universal grading system for renal tumor thrombus.
Measured: The time once the preoperative imaging is assessed, up to 1 weeks.
Primary tumor diameter
Diameter of the primary tumor.
Measured: The time once the preoperative imaging is assessed, up to 1 weeks.
Preoperative tumor node metastasis (TNM) stage
TNM stage according to the preoperative imaging.
Measured: The time once the preoperative imaging is assessed, up to 1 weeks.
IVC residual blood flow
Inferior vena cava residual blood flow according to ultrasonography.
Measured: The time once the preoperative imaging is assessed, up to 1 weeks.
IVC vascular wall continuity
Inferior vena cava vascular wall continuity according to ultrasonography.
Measured: The time once the preoperative imaging is assessed, up to 1 weeks.
IVC complete occlusion
Whether the inferior vena cava is completely occluded according to ultrasonography.
Measured: The time once the preoperative imaging is assessed, up to 1 weeks.
IVC enhanced synchronization with tumor thrombus
Whether the inferior vena cava enhanced synchronization with tumor thrombus according to ultrasonography.
Measured: The time once the preoperative imaging is assessed, up to 1 weeks.
Tumor thrombus move when breathe
Whether the tumor thrombus move when breathe according to ultrasonography.
Measured: The time once the preoperative imaging is assessed, up to 1 weeks.
Maximum IVC anterior-posterior (AP) diameter
Maximum inferior vena cava anterior-posterior diameter according to CT/ MRI.
Measured: The time once the preoperative imaging was assessed, up to 1 weeks.
Maximum coronal IVC diameter
Maximun coronal inferior vena cava diameter according to CT/ MRI.
Measured: The time once the preoperative imaging is assessed, up to 1 weeks.
Maximum IVC AP diameter at the Rvo
Maximum inferior vena cava anterior-posterior diameter at the renal vein ostium according to CT/ MRI.
Measured: The time once the preoperative imaging is assessed, up to 1 weeks.
Maximum coronal IVC diameter at the Rvo
Maximun coronal inferior vena cava diameter at the renal vein ostium according to CT/ MRI.
Measured: The time once the preoperative imaging is assessed, up to 1 weeks.
Bland thrombus
The presence of bland thrombus in inferior vena cava according to CT/ MRI.
Measured: The time once the preoperative imaging is assessed, up to 1 weeks.
growing against the direction of venous return (GADVR)
The presence of tumor thrombus growing against the direction of venous return according to CT/ MRI.
Measured: The time once the preoperative imaging is assessed, up to 1 weeks.
Surgery approach
Radical nephrectomy and at least one kind of IVC thrombectomy (including IVC incision only, IVC partial resection, IVC diagonal resection, and IVC segmental resection)
Measured: The time once the surgery finished, an average of 10 days.
Surgery time
Surgery time
Measured: The time once the surgery finished, an average of 10 days.
Blood loss
Blood loss during surgery
Measured: The time once the surgery finished, an average of 10 days.
Histological type
Histological type of the tumor according to pathological examination.
Measured: The time once the pathological specimen is assessed, up to 1 weeks.
Postoperative TNM stage
TNM stage according to pathological examination.
Measured: The time once the pathological specimen is assessed, up to 1 weeks.
Invaded vascular wall layer
The deepest Inferior vane cava vascular wall layer the tumor thrombus invaded.
Measured: The time once the pathological specimen is assessed, up to 1 weeks.
Comorbidity occurence
The comorbidity occurence after surgery.
Measured: From the end of surgery until discharge, up to 3 weeks.
Recurrence free survival
The duration from the date of diagnosis to death, last follow-up, or cancer recurrence.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Tumor metastasis
Location and time that the metastasis occurs.
Measured: Through study completion, an average of 3 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Jan 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhuo, Peking University Third Hospital
- Investigators
- Zhuo Liu, MD, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589207
- Sponsor's protocol ID
- M2022597
- Status last verified
- Feb 2023
- First submitted
- 15 Oct 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Adams LC, Ralla B, Bender YY, Bressem K, Hamm B, Busch J, Fuller F, Makowski MR. Renal cell carcinoma with venous extension: prediction of inferior vena cava wall invasion by MRI. Cancer Imaging. 2018 May 3;18(1):17. doi: 10.1186/s40644-018-0150-z.
PubMed 29724245Ingels A, Campi R, Capitanio U, Amparore D, Bertolo R, Carbonara U, Erdem S, Kara O, Klatte T, Kriegmair MC, Marchioni M, Mir MC, Ouzaid I, Pavan N, Pecoraro A, Roussel E, de la Taille A. Complementary roles of surgery and systemic treatment in clear cell renal cell carcinoma. Nat Rev Urol. 2022 Jul;19(7):391-418. doi: 10.1038/s41585-022-00592-3. Epub 2022 May 11.
PubMed 35546184Labbate C, Hatogai K, Werntz R, Stadler WM, Steinberg GD, Eggener S, Sweis RF. Complete response of renal cell carcinoma vena cava tumor thrombus to neoadjuvant immunotherapy. J Immunother Cancer. 2019 Mar 11;7(1):66. doi: 10.1186/s40425-019-0546-8.
PubMed 30857555Shi T, Huang Q, Liu K, Du S, Fan Y, Yang L, Peng C, Shen D, Wang Z, Gao Y, Gu L, Niu S, Ai Q, Li H, Liu F, Li Q, Wang H, Guo A, Fu B, Yang X, Zhang X, Wang D, Wang D, Guo H, Li H, Olivero A, Fam XI, Ma X, Wang B, Zhang X. Robot-assisted Cavectomy Versus Thrombectomy for Level II Inferior Vena Cava Thrombus: Decision-making Scheme and Multi-institutional Analysis. Eur Urol. 2020 Oct;78(4):592-602. doi: 10.1016/j.eururo.2020.03.020. Epub 2020 Apr 15.
PubMed 32305170Liu Z, Zhao X, Zhang HX, Li LW, Tang SY, Wang GL, Zhang SD, Wang SM, Ma LL, Tian XJ. Surgical complexity and prognostic outcome of small volume renal cell carcinoma with high-level venous tumor thrombus and large volume renal cell carcinoma with low-level thrombus. Chin Med J (Engl). 2019 Aug 5;132(15):1780-1787. doi: 10.1097/CM9.0000000000000352.
PubMed 31306232Rodriguez Faba O, Linares E, Tilki D, Capitanio U, Evans CP, Montorsi F, Martinez-Salamanca JI, Libertino J, Gontero P, Palou J. Impact of Microscopic Wall Invasion of the Renal Vein or Inferior Vena Cava on Cancer-specific Survival in Patients with Renal Cell Carcinoma and Tumor Thrombus: A Multi-institutional Analysis from the International Renal Cell Carcinoma-Venous Thrombus Consortium. Eur Urol Focus. 2018 Apr;4(3):435-441. doi: 10.1016/j.euf.2017.01.009. Epub 2017 Feb 9.
PubMed 28753848Lardas M, Stewart F, Scrimgeour D, Hofmann F, Marconi L, Dabestani S, Bex A, Volpe A, Canfield SE, Staehler M, Hora M, Powles T, Merseburger AS, Kuczyk MA, Bensalah K, Mulders PF, Ljungberg B, Lam TB. Systematic Review of Surgical Management of Nonmetastatic Renal Cell Carcinoma with Vena Caval Thrombus. Eur Urol. 2016 Aug;70(2):265-80. doi: 10.1016/j.eururo.2015.11.034. Epub 2015 Dec 23.
PubMed 26707869Wagner B, Patard JJ, Mejean A, Bensalah K, Verhoest G, Zigeuner R, Ficarra V, Tostain J, Mulders P, Chautard D, Descotes JL, de la Taille A, Salomon L, Prayer-Galetti T, Cindolo L, Valeri A, Meyer N, Jacqmin D, Lang H. Prognostic value of renal vein and inferior vena cava involvement in renal cell carcinoma. Eur Urol. 2009 Feb;55(2):452-9. doi: 10.1016/j.eururo.2008.07.053. Epub 2008 Aug 5.
PubMed 18692951Liu Z, Li L, Hong P, Zhu G, Tang S, Zhao X, Zhang Q, Wang G, He W, Zhang H, Xue H, Cui L, Ge H, Jiang J, Zhang S, Cao F, Yan J, Ma F, Liu C, Ma L, Wang S. A Predictive Model for Tumor Invasion of the Inferior Vena Cava Wall Using Multimodal Imaging in Patients with Renal Cell Carcinoma and Inferior Vena Cava Tumor Thrombus. Biomed Res Int. 2020 Oct 6;2020:9530618. doi: 10.1155/2020/9530618. eCollection 2020.
PubMed 33083491Wang BS, Li YZ, Fang YY, Zhang SD, Ma LL. Imaging predictors for assessment of inferior vena cava wall invasion in patients with renal cell carcinoma and inferior vena cava tumor thrombus: a retrospective study. Chin Med J (Engl). 2020 Sep 5;133(17):2078-2083. doi: 10.1097/CM9.0000000000000828.
PubMed 32898352Li QY, Li N, Huang QB, Luo YK, Wang BJ, Guo AT, Ma X, Zhang X, Tang J. Contrast-enhanced ultrasound in detecting wall invasion and differentiating bland from tumor thrombus during robot-assisted inferior vena cava thrombectomy for renal cell carcinoma. Cancer Imaging. 2019 Dec 2;19(1):79. doi: 10.1186/s40644-019-0265-x.
PubMed 31791422Sun Z, Cui Y, Xu C, Yu Y, Han C, Liu X, Lin Z, Wang X, Li C, Zhang X, Wang X. Preoperative Prediction of Inferior Vena Cava Wall Invasion of Tumor Thrombus in Renal Cell Carcinoma: Radiomics Models Based on Magnetic Resonance Imaging. Front Oncol. 2022 Jun 6;12:863534. doi: 10.3389/fonc.2022.863534. eCollection 2022.
PubMed 35734586Ueki H, Terakawa T, Ueno Y, Sofue K, Horii S, Okamura Y, Bando Y, Hara T, Furukawa J, Harada K, Hinata N, Nakano Y, Murakami T, Fujisawa M. Efficacy of preoperative cine magnetic resonance imaging in evaluation of adhesion of renal cancer thrombus to inferior vena cava wall. J Vasc Surg Venous Lymphat Disord. 2022 Jul;10(4):908-915. doi: 10.1016/j.jvsv.2022.02.016. Epub 2022 Mar 18.
PubMed 35314389Hirono M, Kobayashi M, Tsushima T, Obara W, Shinohara N, Ito K, Eto M, Takayama T, Fujii Y, Nishikido M, Kimura G, Kishida T, Takahashi M, Miyao N, Naya Y, Abe T, Fujioka T, Ito K, Naito S; Members of the Japanese Society of Renal Cancer. Impacts of clinicopathologic and operative factors on short-term and long-term survival in renal cell carcinoma with venous tumor thrombus extension: a multi-institutional retrospective study in Japan. BMC Cancer. 2013 Oct 2;13:447. doi: 10.1186/1471-2407-13-447.
PubMed 24083566
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Imaging Diagnostic Evaluation Model Based on Evidence-based Pathological Diagnose Criteria for Renal Cell Carcinoma Tumor Thrombus With Inferior Vena Cava Wall Invasion
- ClinicalTrials.gov ID
- NCT05589207
- Acronym / sponsor ID
- M2022597
- Conditions
- Carcinoma, Renal Cell, Tumor Thrombus, Neoplasm Invasiveness, Inferior Vena Cava Interruption
- Keywords
- Neoplasm Grading, Diagnostic Model, Preoperative Diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to establish a preoperative imaging diagnostic model which highly consistent with the histopathological examinations, as well as a accurate and systematic pathological grading standard of inferior vena cava (IVC) vascular wall invasion in renal cell carcinoma (RCC) with tumor thrombus invading vascular wall.The main questions it aims to answer are:
- To establish a preoperative imaging diagnostic model which highly consistent with the histopathological examinations.
- To determine what impact does different vascular wall layer invasion make on the long-term prognosis in RCC with IVC tumor thrombus;
- To determine which layer invasion according to pathological examination make sense to clinical treatment (can significantly affect prognosis); Participants with IVC vascular wall invasion/ non-invasion are divided into experimental group (invaded group) or control group (non-invaded group) respectively according to pathological examinations, in order to establish a prospective cohort with three-year follow-up. The pathological characteristics of local recurrence and poor prognosis are summarized, and postoperative pathological diagnostic criteria of IVC vascular wall invasion and established. The local recurrence and distant recurrence outcomes are compared between experiment group and control group, in order to analyze the long-term influence of vascular wall invasion. Then the preoperative imaging diagnostic evaluation model will be established.
Detailed description
Radical nephrectomy and thrombectomy are essential surgical treatments for renal cell carcinoma (RCC) with inferior vena cava (IVC) tumor thrombus. IVC vascular wall invasion leads to higher recurrence risk and worse long-term prognosis. The diagnosis and treatment of RCC tumor thrombus with IVC vascular wall invaded are affected by prominent difficulties: First, there is a lack of the preoperative diagnostic evaluation system consisting to the postoperative histopathological examinations, which is regarded as the gold standard of vascular wall invasion, therefore hinders the development of the neoadjuvant therapy strategy and surgery plan; Besides, the pathological diagnostic criteria of IVC vascular wall adhesion or invasion is inconsistent among different centers, an accurate and systematic criteria is needed.
This study consecutively includes patients admitted in Peking University Third Hospital between January 2023 to January 2026, who were diagnosed with primary renal cell carcinoma with IVC tumor thrombus with/without vascular wall invasion, and accepted radical nephrectomy and at least one IVC thrombectomy (including IVC incision only, IVC partial resection, IVC diagonal resection, and IVC segmental resection). The patients with IVC vascular wall invasion/ non-invasion are divided into experimental group (invaded group) or control group (non-invaded group) respectively according to pathological examinations, in order to establish a prospective cohort with three-year follow-up. For the invaded group, micro invasion subgroup and tumor thrombus capsule subgroup analysis are conducted. The pathological characteristics of local recurrence and poor prognosis are summarized, and postoperative pathological diagnostic criteria of IVC vascular wall invasion and established. The local recurrence and distant recurrences outcomes are compared between experiment group and control group, in order to analyze the long-term influence of vascular wall invasion. Then the preoperative imaging diagnostic evaluation model were established: re-diagnose patients in two groups according to the established pathological diagnostic criteria, and divide them into truly-invaded group and truly-non-invaded group. Analyzing the preoperative abdominal ultrasound scan, contrast-enhanced ultrasonography, computed tomography (CT) and magnetic resonance imaging (MRI), thus explore the imaging characteristics of vascular wall invasion and establish the preoperative diagnostic model. This study aims at establish a preoperative imaging diagnostic model which highly consistent with the histopathological examinations, as well as a accurate and systematic pathological grading standard of IVC vascular wall invasion, therefore contribute to the development of a more accurate and effective preoperative treatment strategy and surgery plan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Invaded Group | – | Diagnostic Test: Vascular wall invadedPatients whose inferior vena cava vascular wall is invaded according to histopathological examination. |
| Non-invaded group | – | –Patients whose inferior vena cava vascular wall is not invaded according to histopathological examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The groups of cohort will be selected from inhospital patients in Peking University Third Hospital.
Key inclusion criteria (8 listed)
- Adults ≥18 years of age;
- Accepted abdominal ultrasonography, contrast-induced ultrasonography, enhanced CT and MRI before the surgery;
- Diagnosis of primary renal cell carcinoma with tumor thrombus before and during the surgery;
- Received radical nephrectomy and at least one kind of thrombectomy (including IVC incision only, IVC partial resection, IVC diagonal resection, and IVC segmental resection)
- Can tolerate the surgery;
Key exclusion criteria (5 listed)
- Failed to receive standard nephrectomy for any reason;
- Attached other addition operations in the surgery;
- Received neoadjuvant treatment before the surgery;
- Experience any other conditions that may affect the curative effect (e.g. active tuberculosis, autoimmune disease, or oral glucocorticoids treatment);
- Experience serious consequences or death due to anesthesia accident during operation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vascular wall invadedInferior vena cava vascular wall is invaded according to pathologic examination on the postoperative tumor thrombus/ vascular wall specimen. | Diagnostic test | Invaded Group |
Primary outcome
Overall survival
Time frame: From date of randomization until the date of lost follow-up or date of death from any cause, whichever came first, assessed up to 120 months
The duration from the date of diagnosis to death or last follow-up, with no restriction on the cause of death.
24 secondary outcomes
Clinical manifestation
Time frame: From the clinical diagnosis until the surgery, an average of 3 weeks
Mayo classification
Time frame: The time once the preoperative imaging is assessed, up to 1 weeks.
Primary tumor diameter
Time frame: The time once the preoperative imaging is assessed, up to 1 weeks.
Preoperative tumor node metastasis (TNM) stage
Time frame: The time once the preoperative imaging is assessed, up to 1 weeks.
IVC residual blood flow
Time frame: The time once the preoperative imaging is assessed, up to 1 weeks.
IVC vascular wall continuity
Time frame: The time once the preoperative imaging is assessed, up to 1 weeks.
IVC complete occlusion
Time frame: The time once the preoperative imaging is assessed, up to 1 weeks.
IVC enhanced synchronization with tumor thrombus
Time frame: The time once the preoperative imaging is assessed, up to 1 weeks.
Tumor thrombus move when breathe
Time frame: The time once the preoperative imaging is assessed, up to 1 weeks.
Maximum IVC anterior-posterior (AP) diameter
Time frame: The time once the preoperative imaging was assessed, up to 1 weeks.
Maximum coronal IVC diameter
Time frame: The time once the preoperative imaging is assessed, up to 1 weeks.
Maximum IVC AP diameter at the Rvo
Time frame: The time once the preoperative imaging is assessed, up to 1 weeks.
Maximum coronal IVC diameter at the Rvo
Time frame: The time once the preoperative imaging is assessed, up to 1 weeks.
Bland thrombus
Time frame: The time once the preoperative imaging is assessed, up to 1 weeks.
growing against the direction of venous return (GADVR)
Time frame: The time once the preoperative imaging is assessed, up to 1 weeks.
Surgery approach
Time frame: The time once the surgery finished, an average of 10 days.
Surgery time
Time frame: The time once the surgery finished, an average of 10 days.
Blood loss
Time frame: The time once the surgery finished, an average of 10 days.
Histological type
Time frame: The time once the pathological specimen is assessed, up to 1 weeks.
Postoperative TNM stage
Time frame: The time once the pathological specimen is assessed, up to 1 weeks.
Invaded vascular wall layer
Time frame: The time once the pathological specimen is assessed, up to 1 weeks.
Comorbidity occurence
Time frame: From the end of surgery until discharge, up to 3 weeks.
Recurrence free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Tumor metastasis
Time frame: Through study completion, an average of 3 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Background: PubMed 29724245Adams LC, Ralla B, Bender YY, Bressem K, Hamm B, Busch J, Fuller F, Makowski MR. Renal cell carcinoma with venous extension: prediction of inferior vena cava wall invasion by MRI. Cancer Imaging. 2018 May 3;18(1):17. doi: 10.1186/s40644-018-0150-z.
- Background: PubMed 35546184Ingels A, Campi R, Capitanio U, Amparore D, Bertolo R, Carbonara U, Erdem S, Kara O, Klatte T, Kriegmair MC, Marchioni M, Mir MC, Ouzaid I, Pavan N, Pecoraro A, Roussel E, de la Taille A. Complementary roles of surgery and systemic treatment in clear cell renal cell carcinoma. Nat Rev Urol. 2022 Jul;19(7):391-418. doi: 10.1038/s41585-022-00592-3. Epub 2022 May 11.
- Background: PubMed 30857555Labbate C, Hatogai K, Werntz R, Stadler WM, Steinberg GD, Eggener S, Sweis RF. Complete response of renal cell carcinoma vena cava tumor thrombus to neoadjuvant immunotherapy. J Immunother Cancer. 2019 Mar 11;7(1):66. doi: 10.1186/s40425-019-0546-8.
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- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhuo Liu, MD study director
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Renal Cell and Tumor Thrombus, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiyuan Chen, MD (+86 18801430995, 1910301319@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From date of randomization until the date of lost follow-up or date of death from any cause, whichever came first, assessed up to 120 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05589207, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.