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Clinical Trial of Human Circulating Tumor DNA Multi-gene Mutation Detection Kit (Reversible Terminal Termination Sequencing)

Clinical Trial of Human Circulating Tumor DNA Multi-gene Mutation Detection Kit (Reversible Terminal Termination Sequencing)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200055965
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:Kit information to be evaluated: (1) Product name: Human Circulating Tumor DNA Multi-gene Mutation Combined Detection Kit (reversible terminal Termination sequencing)
(2) Packing specification: 24pcs/box
(3) Storage conditions: Kit 1 was stored at -25~-15?, Kit 2 at -85~-70?, Kit 3 at 2-8 ?, kit 4 at 10-30 ?

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