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A case-control study on screening biomarkers of Genitourinary tumors based on machine learning and plasma metabolomics methods

A case-control study on screening biomarkers of Genitourinary tumors based on machine learning and plasma metabolomics methods

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500107504
Enrollment
Unknown
Registered
2025-08-13
Start date
2025-08-31
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder cancer

Interventions

Index test:Plasma non-targeted metabolomics detection

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 74 Years

Inclusion criteria

Inclusion criteria: 1) Inclusion criteria for the case group: a. Age >=18 years and =18 years and =18 years and < 75 years. b. Suffering from benign diseases with symptoms similar to those of urogenital system tumors, such as benign prostatic hyperplasia, kidney stones, urinary tract infections, benign tumors, etc. c. There are sufficient clinical data, including pathological reports, imaging examination results, etc. d. Have a stable overall condition, with normal vital signs such as heart rate, blood pressure, and blood oxygen saturation, and laboratory test results such as blood routine, biochemistry, and coagulation function within an acceptable range. e. The patient is willing to participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Exclusion criteria for the case group: a. The subjects, in addition to prostate cancer/bladder cancer/kidney cancer, have major diseases that seriously affect the plasma metabolic profile, such as severe liver or kidney diseases, uncontrolled diabetes, severe infections, AIDS, autoimmune diseases or other concurrent malignant tumors, etc. b. Has received any treatment for prostate cancer/bladder cancer/kidney cancer, including chemotherapy, radiotherapy, targeted therapy, etc. c. Accompanied by other malignant tumors, unless it is basal cell carcinoma or squamous cell carcinoma of the skin that has been cured for more than 5 years. d. Has a history of mental illness, drug abuse, or drug dependence. e. Those who have received manual surgery within the past 7 days. f. Those who have donated blood or suffered heavy bleeding (> 450mL) within the past 7 days, or have received blood transfusion or used blood products. g. Positive pregnancy test results and lactating women. h. Subjects who are not suitable for enrollment for other reasons as considered by the researchers. 2) Exclusion criteria for the healthy control group: a. History of any type of malignant tumor. b. There are severe infections, malnutrition, severe anemia and other conditions that seriously affect the results of metabolomics tests. c. Suffering from chronic diseases that affect immune function or metabolism, such as AIDS, autoimmune diseases, diabetes that have not been effectively controlled, etc. d. There has been a long-term medication history within the past six months. e. There is a history of mental illness, drug abuse, or drug dependence. f. Those who have undergone manual surgery within the last three months. g. Those who have donated blood or suffered significant bleeding (> 450mL) within the past three months, or have received blood transfuses or used blood products. h. Positive pregnancy test and lactating women. i. Subjects who are not suitable for enrollment for other reasons as considered by the researchers. 3) Exclusion criteria for the benign disease interference group: a. After thorough assessment, the subjects were found to have malignant tumors, especially those in the urogenital system. b. There are other major diseases that seriously affect metabolism or immune function, such as end-stage renal disease, liver cirrhosis, autoimmune diseases, uncontrolled diabetes, etc. c. There is a history of mental illness, drug abuse, or drug dependence. d. Those who have undergone manual surgery within the last three months. e. Those who have donated blood or suffered significant bleeding (more than 450mL) within the last three months, or have received blood transfusion or used blood products. f. Positive pregnancy test results and lactating women. g. Subjects who are not suitable for enrollment for other reasons as considered by the researcher.

Design outcomes

Primary

MeasureTime frame
Area Under Curve;Sensitivity;Specificity;

Countries

China

Contacts

Public ContactXiaoping Zhang

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

xzhang@hust.edu.cn+86 27 8572 6685

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026