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Prospective, single-center observation study of tissue and blood consistency and dynamic changes of EGFR, KRAS, P53 gene mutation detection of lung cancer using a new liquid biopsy technology based on red blood cells

Prospective, single-center observation study of tissue and blood consistency and dynamic changes of EGFR, KRAS, P53 gene mutation detection of lung cancer using a new liquid biopsy technology based on red blood cells

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100042604
Enrollment
Unknown
Registered
2021-01-24
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-05-03

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:gene mutaiton detection using tumor tissue
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using&#32
blood&#32

Sponsors

Department of Thoracic Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18-85 years; 2) Chest CT indicated that pulmonary lesions had the characteristics of malignant lesions; 3) Did not receive any anti-tumor intervention therapy, including radiotherapy, chemotherapy, immunotherapy, etc.Does not include antibiotic treatment; 4) Non-small cell lung cancer can be confirmed by puncture or surgery; 5) Be willing to provide blood samples and tissue samples for this clinical study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) There are other malignant tumors at the same time, including adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and ductal carcinoma in situ after radical resection; 2) The investigator determined that the subjects had other serious non-tumor diseases that might affect follow-up and short-term survival; 3) Subjects who have previously received anti-tumor therapy such as surgery, chemotherapy, targeted or immunotherapy; 4) Clinically definite active infection, including but not limited to pneumonia, tuberculosis, cryptococcosis and other infections; 5) Subjects who cannot obtain the results of EGFR, KRAS and P53 mutations in tissues or red blood cells due to unqualified quality inspection of samples; 6) Subjects who cannot receive any anti-tumor intervention therapy; 7) Female subjects during pregnancy or lactation; 8) Other researchers think it is not suitable to be included in the group.

Design outcomes

Primary

MeasureTime frame
EGFR mutation;KRAS mutation;P53 mutation;

Countries

China

Contacts

Public ContactQihan Chen
chenqihan@nju.edu.cn+86 25-67985473

Outcome results

None listed

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