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Clinical trial of circulating tumor DNA gene mutation sequencing data analysis software

Clinical trial of circulating tumor DNA gene mutation sequencing data analysis software

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200055964
Enrollment
Unknown
Registered
2022-01-30
Start date
2022-03-01
Completion date
Unknown
Last updated
2024-07-15

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

Conditions

Advanced non-small cell lung cancer

Interventions

Index test:Information of the device to be evaluated: 1. Product name: software for sequencing data analysis of circulating tumor DNA gene mutations
2. Model specification: BRTMAS-CTDNA
3. Manufacturer: Guangzhou Burning Rock Dx Co., Ltd.

Sponsors

Cancer Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Sign a written informed consent to participate in the study; 2. Aged 18 and above; 3. Patients with advanced non-small cell lung cancer (NSCLC) or small cell lung cancer confirmed by histology or cytology; 4. Sample collection shall meet the following requirements: (1) Peripheral blood can be collected with a sample size of 8-10ml. (2) Blood collection should be completed before the first targeted therapy for patients who are newly treated or have not previously received targeted therapy; (3) After treatment, blood collection should be completed before the beginning of the next line treatment; (4) Tissue is accessible and sufficient matching paraffin-embedded tumor tissue samples (FFPE) can be obtained at the same time as blood samples (such as samples taken at treatment baseline or samples taken after first-line targeted therapy resistance), and the proportion of tumor cells assessed by pathology is not less than 20%.

Exclusion criteria

Exclusion criteria: 1. The samples are contaminated or suspiciously contaminated, or there is a lot of hemolysis and lipemia in the samples; 2. Patients who have received allogeneic blood transfusion or other treatments that may introduce foreign DNA within 3 months; 3. Plasma was not separated from peripheral blood samples within the specified time; 4. Tissue samples cannot meet testing requirements (such as insufficient tissue samples, lost wax blocks, etc.); 5. Repeated sampling from the same case; 6. Exceeding number of cases (competing for inclusion); 7. The basic information of the sample is incomplete (including but not limited to the tracing ID number of the subject, pathological diagnosis/clinical diagnosis and clinical stage), and is not standardized, such as lack of key tracing information and unclear diagnostic information, etc.

Design outcomes

Primary

MeasureTime frame
Advanced non-small cell lung cancer gene;

Countries

China

Contacts

Public ContactTang Yuan, Lu You

West China Hospital, Sichuan University

1202ty@163.com+86 18980601646, +86 28 85423571

Outcome results

None listed

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