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Study for LCRMP4 protein detection ELISA kit in the diagnosis and prognosis prediction of prostate cancer

Study for LCRMP4 protein detection ELISA kit in the diagnosis and prognosis prediction of prostate cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000033399
Enrollment
Unknown
Registered
2020-05-31
Start date
2020-06-08
Completion date
Unknown
Last updated
2020-06-01

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

Conditions

Prostate Cancer

Interventions

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Sponsors

The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. male; 2. Aged >=18 years old; 3. Did not receive treatment including endocrine therapy, chemotherapy, immunotherapy, etc.; 4. ECGO score 0-1 points (see Annex 1); 5. The functions of major organs such as liver, kidney, bone marrow, heart and other important organs have no obvious abnormalities. AST, ALT=3.5x10^9/L, neutrophils >=1.5x10^9/L, hemoglobin >=90g/L, platelets >=80x10^9/L; ECG is not obvious Abnormality, or abnormality has no clinical significance; 6. Be able to understand this research project and sign the informed consent. Youth control group: 7. Additional to above 6 items, no prostatitis and urogenital system diseases, no autoimmune system diseases, PSA 4ng / ml, digital rectal examination, prostate ultrasound, mpMRI suggest PCa; 10. LCRMP4 compares ECT, MRI and PSMA to predict PCa metastasis: addition to item 9, plus medium and high-risk PCa diagnosed by prostate puncture (PSA> 10ng / ml, Gleason Score >=7, cTc >=T2c) 11. LCRMP4 compared with Select gene chip to predict biochemical recurrence after radical prostatectomy: additional to item 9, plus localized PCa (PSA =7, cT2) + radical prostatectomy.

Exclusion criteria

Exclusion criteria: According to the judgment of the doctor, the subject has any other serious diseases or clinical conditions and cannot safely participate in the research of this project. Any other serious diseases or clinical conditions are not limited to the following items listed: (1) Any infection >=Level 2 of the National Cancer Institute Common Terminology Standard for Adverse Events (NCI-CTCAE) version 4.03; (2) Heart failure (New York Heart Collaboration Group NYHA) category III or IV; (3) Crohn's disease or ulcerative colitis; (4) Incontinence; (5) Drug abuse, medical, psychological or social conditions that may interfere with the participant s participation in the study or evaluation of the study results; (6) There is any unstable disease or clinical condition, or it may endanger the safety of the subject and affect the research compliance of the subject; (7) Other malignant tumors (within 5 years), except non-melanoma skin cancer.

Design outcomes

Primary

MeasureTime frame
Blood LCRMP4 protein level;Prostate biopsy;MRI;B ultrasound;ECT;PSMA PET-CT;Blood PSA level;Gleason Score;

Countries

China

Contacts

Public ContactGAO XIN

The Third Affiliated Hospital of Sun Yat-sen University

gaoxin44@vip.163.com+86-13929571713

Outcome results

None listed

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