bladder cancer
Conditions
Interventions
Index test:HK2 positive cell.
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: [1] Subjects must provide informed consent before undertaking any research specific procedures; [2] Age is greater than or equal to 18 years old; [3] Patients with primary bladder cancer confirmed by pathology and healthy persons without history of malignant tumor; [4] Patients must have normal organ and bone marrow function within 28 days before the study; [5] Postmenopausal women or women of childbearing age who are not in a fertile state: Within 28 days after the start of the study, urine or serum pregnancy test results are negative, and reconfirmed before collecting urine on the first day; [6] During the study period, patients were willing and able to follow the study protocol, including treatment and planned visits and examinations.
Exclusion criteria
Exclusion criteria: [1] Participate in research planning and / or implementation (applicable to staff and / or research center staff). [2] Participated in another clinical study involving experimental drugs during the most recent course of chemotherapy [3] Other malignant tumors in the past 5 years, except: properly treated non-melanoma skin cancer, cured cervical carcinoma in situ, ductal carcinoma in situ (DCIS), stage 1, grade 1 endometrial cancer, or Solid tumors including lymphoma (without bone marrow infiltration) have been cured and no signs of disease >= 5 years. Patients with a history of local triple-negative breast cancer may be eligible for enrollment, provided they have completed adjuvant chemotherapy for more than three years before registration, and the patient has no relapse or metastatic disease. [4] 2 or more resting electrocardiograms with QTc > 470 ms or a family history of long QT syndrome within 24 hours [5] Patients with myelodysplastic syndrome / acute myeloid leukemia or showing MDS / AML features. [6] The patient has uncontrollable symptomatic brain metastases. No radiographic scan is required to confirm the absence of brain metastases. Patients can receive a fixed dose of corticosteroids before and during the study, but these treatments are required to start at least 4 weeks before treatment. Patients with spinal cord compression unless deemed to have received definitive treatment for this and have clinical signs of stable disease for 28 days. [7] Underwent major surgery within 2 weeks before starting treatment, or did not recover from the impact of any major surgery. [8] Due to serious and uncontrollable medical diseases, patients with non-malignant systemic diseases or active, uncontrollable infections have greater medical risks. Examples include, but are not limited to, uncontrolled ventricular arrhythmias, recent (within 3 months). myocardial infarction, uncontrolled major seizures, unstable spinal cord compression, superior vena cava syndrome, high-resolution computed tomography ( HRCT) shows bilateral generalized interstitial lung disease or all mental diseases without informed consent. [9] Patients who are unable to swallow drugs and patients with gastrointestinal disorders that may affect the absorption of the study drug. [10] Lactating women. [11] Patients with immunodeficiency, for example, patients who are serologically positive for human immunodeficiency virus (HIV). [12] Patients who are known to have active hepatitis (ie, hepatitis B or C) are at risk of transmitting the disease through blood or other body fluids. [13] Previous allogeneic bone marrow transplantation or double cord blood transplantation (dUCBT). [14] Received whole blood transfusion 120 days before enrolling in the study (red blood cell and platelet transfusion is acceptable, the time refers to the selection criteria 5).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under The Curve;SEN, SPE, ACC; | — |
Countries
China
Contacts
Public ContactZhihong Liu
Shanghai General Hospital
Outcome results
None listed