Skip to content

Development of a new plasma-microRNA-based diagnostic kit for lung cancer

Development of a new plasma-microRNA-based diagnostic kit for lung cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100049485
Enrollment
Unknown
Registered
2021-08-02
Start date
2021-08-05
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

lung cancer

Interventions

Gold Standard:The "gold standard" to determine lung cancer in this study is histopathology.
Index test:PCR&#32
was&#32
used&#32
to&#32
and&#32
the&#32
of&#32
serum&#32
in&#32
lung&#32
cancer&#32
patients&#32

Sponsors

Shanghai Pulmonary Hospital, Tongji University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily participate in clinical research; fully understand and inform this research and sign an informed consent form (ICF); be willing to follow and have the ability to complete all experimental procedures; 2. Male or female aged 18-80 years (inclusive) when signing the ICF. ; 3. All patients included in the analysis had cancer cells found by pathology before or after surgery, and were confirmed to be lung cancer by immunohistochemistry; 4. The patient has not received any systemic therapy related to malignant tumor in the past; 5. Patients must provide qualified plasma samples for microRNA expression level determination; 6. Relevant laboratory tests suggest that they can tolerate radical lung cancer surgery.

Exclusion criteria

Exclusion criteria: 1. Patients with unclear diagnosis of lung cancer; 2. Patients with contraindications to surgery; 3. Suffering from other active malignant tumors within the year or at the same time. Localized tumors that have been cured, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, and carcinoma in situ of the breast can be enrolled; 4. Human immunodeficiency virus (HIV) infection; 5. Patients with active pulmonary tuberculosis; 6. Received treatment with live vaccines within 28 days before the first dose. However, inactivated viral vaccines are allowed to treat seasonal influenza, but intranasal live attenuated influenza vaccines are not allowed; 7. Women who are pregnant or breastfeeding; 8. The patient has a known history of psychotropic substance abuse or drug abuse; the patient has a history of alcoholism; 9. According to the judgment of the investigator, the patient has other factors that may lead to the early termination of this study.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;

Countries

China

Contacts

Public ContactZhu Yuming

Shanghai Pulmonary Hospital

ymzhu2005@aliyun.com+86 13003269312

Outcome results

None listed

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