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SZ-PILOT Study: Prospective observational study of the YiDiXueTM multi-cancer early detection Kit in multi-cancer early screening in normal people

SZ-PILOT Study: Prospective observational study of the YiDiXueTM multi-cancer early detection Kit in multi-cancer early screening in normal people

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200066840
Enrollment
Unknown
Registered
2022-12-19
Start date
2022-12-19
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

Cancer(multi-cancer)

Interventions

Gold Standard:The gold standard for diagnosis of "malignant tumor" is the pathological diagnosis of biopsy or operation. If the subject suspects "malignant tumor" but there is no biopsy pathology or s
Index test:"YiDiXue" multi-cancer early detection kit (Shenzhen Kerida Health Technology Co., LTD.).

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Confirmed case studies: (1) Patients diagnosed with primary malignant tumor by preoperative imaging, gastroenteroscopy or biopsy pathology; (2) Patients who have the ability to understand informed consent and consent to participate in the trial (informed consent is subject to approval by an independent ethics committee and informed consent from patients prior to the commencement of any study-related process; (3) Patients with untreated primary malignancies. 2. Normal population: (1) Age >18 years old, male or female; (2) Subjects who have the ability to understand informed consent and consent to participate in the program (informed consent requires approval by an independent ethics committee and informed consent from the patient prior to the commencement of any study-related process).

Exclusion criteria

Exclusion criteria: 1. Confirmed case study: (1) Patients with primary malignant tumor considered before surgery, but not diagnosed as primary malignant tumor by pathology after surgery; (2) Patients identified as non-malignant tumors after surgery; (3) Patients with other severe liver and kidney function impairment, diabetes, severe infection and cardiac insufficiency; (4) The treated physician considered that the patient's actual condition was not suitable for the study. 2. Normal population: (1) The presence of a known malignancy in the body (has been diagnosed with a malignancy and has not or cannot be surgically removed); (2) Our research group believes that the actual condition of the subjects is not suitable for participating in this project.

Design outcomes

Primary

MeasureTime frame
Total sensitivity;Total specificity;

Secondary

MeasureTime frame
Total positive predictive value;Total negative predictive value;Total accuracy rate (total coincidence rate);

Countries

China

Contacts

Public ContactLai Yongqing

Peking University Shenzhen Hospital

13500058425@163.com+86 135 0005 8425

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 29, 2026