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Multi-omics combination analysis of an observational prospective trial for early screening of skin cancer

Multi-omics combination analysis of an observational prospective trial for early screening of skin cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400088683
Enrollment
Unknown
Registered
2024-08-23
Start date
2024-08-23
Completion date
Unknown
Last updated
2024-08-26

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

Conditions

cutaneum carcinoma

Interventions

Group A (benign nevus confirmed by pathologic histology):None
Group B (malignant skin cancer diagnosed with pathologic histology):None

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) The sample is from the remaining samples of clinical testing, and the remaining sample size meets: 0.8 mL human serum sample; 2) Meet the storage requirements, that is, the samples must be stored at room temperature and centrifuged within 12 hours after collection. And then stored at-60? until analysis; 3) The patient is 18 years old, and the gender is not limited; 4) Body mass index (BMI) at screening was between 18.5-30 kg/m2 (inclusive); 5) Patients with a proposed skin lesion resection, including the following conditions, may be included: A) Patients with a pathological diagnosis of benign nevus; B) Patients with a pathologic diagnosis of malignant skin cancer, including melanoma, cutaneous squamous cell carcinoma, skin base cell carcinoma, and cutaneous sarcoma. The subjects were fully aware of the purpose, nature, and method of the trial, volunteered to participate in the trial, and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Serum samples show blood coagulation or hemolysis phenomenon; 2) Incorrect sample collection or storage; 3) Hyperthyroidism or hypothyroidism that was not well treated during screening; 4) Patients with a systolic blood pressure of 180 mmHg and / or a diastolic blood pressure of 110 mmHg at screening; 5) Hypokalemia, hypocalcemia or hypomagnesemia at screening; 6) Any of the laboratory indicators met the following criteria: A) glutamate aminotransferase> 2.0 ULN and / or glutamate aminotransferase> 2.0 ULN and / or total bilirubin> 1.5 ULN; B) Blood creatinine> 1.5 ULN; C.) The glomerular filtration rate (eGFR) is 5.7 mmol/L and cholesterol> 1.5 ULN; F) Abnormal hemoglobin with clinical significance as judged by the investigator; G) Blood thyroid stimulating hormone (TSH)> 10 mIU / L and is clinically significant as judged by the investigator; 7) Positive hepatitis B surface antigen, hepatitis C antibody, HIV antibody, and / or treponema pallidum antibody; 8) Patients with neurological diseases, brain trauma, cardiovascular and cerebrovascular diseases, and severe abnormal liver and kidney functions; 9) Women born in pregnancy or lactation; 10) Surgery or other major medical history within 6 months; 11) Being on hormonal drug therapy; Patients who the investigator considered other factors to participate in this trial. Patients who the investigator considered other factors to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Serum metabolite concentrations;

Countries

China

Contacts

Public ContactLi Ke

The First Affiliated Hospital of Soochow University

likefggf@163.com+86 153 6517 3126

Outcome results

None listed

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