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Evaluation of the accuracy of a new handheld microscope scanning image for multi cancer scanning judgment: a parallel controlled study protocol

Evaluation of the accuracy of a new handheld microscope scanning image for multi cancer scanning judgment: a parallel controlled study protocol

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400081038
Enrollment
Unknown
Registered
2024-02-21
Start date
2024-02-26
Completion date
Unknown
Last updated
2024-02-26

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

Conditions

Liver cancer, breast cancer, brain glioma

Interventions

Gold Standard:intraoperative frozen
Index test:EndoScell Scanner system scan

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Liver cancer: (1) Between the ages of 18 and 70; (2) Patients diagnosed with liver cancer before surgery, with a maximum tumor diameter of = 3cm assessed by imaging and no evidence of distant metastasis, and planned for surgical resection; (3) The subjects voluntarily sign the informed consent form or are exempted from signing after being reviewed and approved by the ethics committee. (2) Breast cancer: (1) Between the ages of 18 and 70; (2) Early breast cancer Breast tumor is less than 5 cm, cN 0-1; (3) Not invading the skin, subcutaneous tissue, pectoralis major muscle, and nipple areola complex; (4) There is no clinical or imaging evidence of distant metastasis; (5) The subjects voluntarily sign the informed consent form or are exempted from signing after being reviewed and approved by the ethics committee. (3) Glioma: (1) Between the ages of 14 and 80; (2) Patients diagnosed with glioma before surgery, with a maximum tumor diameter of = 3cm according to imaging evaluation, and planned for surgical resection; (3) The subjects voluntarily sign the informed consent form or are exempted from signing after being reviewed and approved by the ethics committee.

Exclusion criteria

Exclusion criteria: (1) Liver cancer: (1) Received anti-tumor treatment methods such as intervention, targeted therapy, and immunotherapy before surgery; (2) Patients with poor overall conditions and inability to tolerate surgery; (3) Those who are unable to obtain satisfactory specimens for both frozen pathology and paraffin pathology during surgery; (4) Those who are unable to obtain paraffin pathology reports; (5) Individuals who are currently participating in other clinical studies and may have an impact on this trial. (2) Breast cancer: (1) Inflammatory breast cancer; (2) Chest wall or skin invasion, local advanced breast cancer; (3) Widespread metastasis of axillary lymph nodes (stage IIIB and above); (4) Individuals with severe comorbidities (such as organ dysfunction, immune deficiency) and poor overall condition; (5) Unable to receive general anesthesia or surgical treatment; (6) Those who are unable to obtain satisfactory specimens for both frozen pathology and paraffin pathology during surgery; (7) Those who are unable to obtain paraffin pathology reports; (8) Individuals who are currently participating in other clinical studies and may have an impact on this trial. (3) Glioma: (1) Received anti-tumor treatment methods such as intervention, targeted therapy, and immunotherapy before surgery; (2) Patients with poor overall conditions and inability to tolerate surgery; (3) Those who are unable to obtain satisfactory specimens for both frozen pathology and paraffin pathology during surgery; (4) Those who are unable to obtain paraffin pathology reports; (5) Individuals who are currently participating in other clinical studies and may have an impact on this trial.

Design outcomes

Primary

MeasureTime frame
Tumor cell morphology;

Secondary

MeasureTime frame
sensitivity of identifying tumor cells;specificity of identifying tumor cells;accuracy of identifying tumor cells;

Countries

China

Contacts

Public ContactJiayin Yang

West China Hospital of Sichuan University

doctoryjy@scu.edu.cn+86 189 8060 2047

Outcome results

None listed

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