Neoplasms

All Conditions

Heart and Blood Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Rare Diseases

Carcinoma

Thrombosis

Carcinoma, Renal Cell

Neoplasm Invasiveness

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Embolism

Embolism and Thrombosis

Vascular Diseases

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Neoplastic Processes

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Herbal and Botanical

All Drugs and Chemicals

Kava

Patients whose inferior vena cava vascular wall is invaded according to histopathological examination.

Patients whose inferior vena cava vascular wall is not invaded according to histopathological examination.

Inferior vena cava vascular wall is invaded according to pathologic examination on the postoperative tumor thrombus/ vascular wall specimen.

Vascular wall invaded

Jiyuan Chen, MD

Zhuo Liu, Doctor

Zhuo Liu, MD

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.

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.

Predicting Model Based on Evidence-based Pathological Diagnose Criteria for RCC Tumor Thrombus With IVC Wall Invasion

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 duration from the date of diagnosis to death or last follow-up, with no restriction on the cause of death.

Clinical manifestation related to the renal carcinoma

A universal grading system for renal tumor thrombus.

TNM stage according to the preoperative imaging.

Inferior vena cava residual blood flow according to ultrasonography.

Inferior vena cava vascular wall continuity according to ultrasonography.

Whether the inferior vena cava is completely occluded according to ultrasonography.

Whether the inferior vena cava enhanced synchronization with tumor thrombus according to ultrasonography.

Whether the tumor thrombus move when breathe according to ultrasonography.

Maximum inferior vena cava anterior-posterior diameter according to CT/ MRI.

Maximun coronal inferior vena cava diameter according to CT/ MRI.

Maximum inferior vena cava anterior-posterior diameter at the renal vein ostium according to CT/ MRI.

Maximun coronal inferior vena cava diameter at the renal vein ostium according to CT/ MRI.

The presence of bland thrombus in inferior vena cava according to CT/ MRI.

The presence of tumor thrombus growing against the direction of venous return according to CT/ MRI.

Radical nephrectomy and at least one kind of IVC thrombectomy (including IVC incision only, IVC partial resection, IVC diagonal resection, and IVC segmental resection)

Histological type of the tumor according to pathological examination.

TNM stage according to pathological examination.

The deepest Inferior vane cava vascular wall layer the tumor thrombus invaded.

The duration from the date of diagnosis to death, last follow-up, or cancer recurrence.

Location and time that the metastasis occurs.

Peking University Third Hospital

Attending Doctor

Digestive System Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

No intervention

Xiangdong Cheng, Professor

Li Yuan, Professor

Xiangdong Cheng, PhD.

This project aims to collect peripheral blood samples from newly diagnosed gastric cancer patients and healthy individuals. Various techniques such as cfDNA sequencing, proteomics, and fragmentomics will be employed to analyze differences in the expression of ctDNA mutations, fragmentomics, and protein biomarkers between gastric cancer patients and healthy individuals. A new comprehensive diagnostic model will be established and its diagnostic value (sensitivity, specificity, accuracy, etc.) for gastric cancer will be validated.

Specifically, the study will involve the following subjects and quantities: 700 participants from Zhejiang Cancer Hospital (350 gastric cancer patients and 350 healthy individuals), 200 participants from Sichuan Cancer Hospital (100 gastric cancer patients and 100 healthy individuals), and 200 participants from the Sixth Affiliated Hospital of Sun Yat-sen University (100 gastric cancer patients and 100 healthy individuals). Peripheral blood samples (a total of 15mL from each participant, collected in 3 tubes) will be collected from all subjects. The collected blood samples will undergo multi-omics sequencing including cfDNA methylation sequencing, proteomics, and genomics to establish a multi-omics-based early diagnostic model.

Preliminary Experimental Study on Key Technologies for Early Screening of Gastric Cancer

This study does not involve clinical trials of drugs; it is solely designed to ensure the confidentiality of patient information. For participant information (such as names and ages), a coding system will be used instead of real names. After enrollment, each case will be assigned an enrollment number. Throughout the entire study, only the main researchers within the research team will have access to participants' real personal data (names, ages) in the electronic database. Distribution and sharing are prohibited. During the publication of articles, the main researchers within the research team will replace participant privacy information (names) with sample codes to achieve de-identification. Furthermore, the protection of participants' personal information will be maintained throughout the study, and any dissemination or leakage is strictly prohibited.

Collect 15ml of peripheral blood from subjects, extract ctDNA, and detect mutations in 18 genes (AKT1, APC, BRAF, CDKN2A, CTNNB1, EGFR, FBXW7, FGFR2, GNAS, HRAS, KRAS, NRAS, PIK3CA, PPP2R1A, PTEN, TP53, TOP2A, RNF43) and the expression levels of 9 tumor-specific proteins (CA-125, CA 19-9, CEA, HGF, IL-6, OPN, Prolactin, AFP, HE4) using the FireflyTM method based on amplicon library deep sequencing. Determine the performance indicators including sensitivity, specificity, and accuracy of the existing AccuScreen system and diagnostic model for early screening of gastric cancer. By conducting tests on 10 samples, explore the genomic fragments of gastric cancer, establish targets for ctDNA fragmentomics (fragment length, cleavage sites, end preferences, etc.), and analysis algorithms for gastric cancer fragmentomics, to further evaluate the feasibility of enhancing sensitivity and specificity for early gastric cancer screening through ctDNA fragmentomics detection.

Zhejiang Cancer Hospital

Secretary of the party committee

Prostatic Neoplasms

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

Patients with PSA between 4 to 10 ng/ml and USTC model predicted probability of cancer less than 0.05 (https://ustcprostatecancerprediction.shinyapps.io/dynnomapp/).

active surveillance without prostate biopsy

active surveillance

Tao Tao

Tao Tao, MD Ph.D

The goal of this observational study is to evaluate the role of the USTC diagnostic model in risk-adaptive strategies for biopsy decision-making in patients with low-risk suspected prostate cancer in order to reduce unnecessary biopsy. Based on the USTC diagnostic model (website: https://ustcprostatecancerprediction.shinyapps.io/dynnomapp/) and serum PSA levels, patients with low-risk suspected prostate cancer are enrolled and received active surveillance rather than biopsy. The main questions to be answered is:

• The safety and feasibility of conducting biopsy-free active monitoring in patients with low-risk suspected prostate cancer accessed by the USTC diagnostic model and serum PSA levels.

Participants will be required to undergo serum PSA testing every 3 months, mpMRI testing every 6 months, and reassessment of the probability of developing prostate cancer using the USTC model every 3 months. Patients who do not meet the inclusion criteria and are at increased risk will no longer receive active surveillance and will be advised to undergo biopsy. Dynamic changes in PI-RADS score and biopsy results will also be recorded.

Conducting Active Surveillance Without Prostate Biopsy for Patients With Low-risk Suspected Prostate Cancer

Conducting Active Surveillance Without Prostate Biopsy for Patients With Low-risk Suspected Prostate Cancer Based on USTC Diagnostic Model and PSA Level: a Multicenter Prospective Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Predicting Model Based on Evidence-based Pathological Diagnose Criteria for RCC Tumor Thrombus With IVC Wall Invasion	NCT05589207	Carcinoma, Rena... Tumor Thrombus Neoplasm Invasi... Inferior Vena C...	Vascular wall i...	18 Years -	Peking University Third Hospital
Preliminary Experimental Study on Key Technologies for Early Screening of Gastric Cancer	NCT05991947	Gastric Cancer Healthy	No intervention	18 Years - 100 Years	Zhejiang Cancer Hospital
Conducting Active Surveillance Without Prostate Biopsy for Patients With Low-risk Suspected Prostate Cancer	NCT05940415	Prostate Cancer	active surveill...	18 Years -	Anhui Provincial Hospital

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