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The combination human 13 gene mutation Detection kit (reversible terminal termination sequencing) complements the clinical trial

The combination human 13 gene mutation Detection kit (reversible terminal termination sequencing) complements the clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000036422
Enrollment
Unknown
Registered
2020-08-23
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-09-14

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

Conditions

non-small cell lung cancer (NSCLC), colorectal cancer (CRC) , gastrointestinal stromal tumor (GIST)

Interventions

Gold Standard:Comparison methods :(1) comparison of similar kits
(2) Sequencing method
gene&#32
Detection&#32
Kit&#32
terminal&#32
termination&#32

Sponsors

Shanghai Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 100 Years

Inclusion criteria

Inclusion criteria: "In this clinical trial, patients with pathologically diagnosed non-small cell lung cancer (NSCLC) or colorectal cancer (CRC) or gastrointestinal stromal tumor (GIST) were selected as the included patients. Meanwhile, some benign tumors were selected as interference samples for detection.The patient's gender and age are not limited. Inclusion criteria for the case group (in line with 1 and 4 or in line with 2 and 4 or in line with 3 and 4): 1. Patients with pathologically diagnosed non-small cell lung cancer (NSCLC); 2. Patients with pathological diagnosis of colorectal cancer (CRC); 3. Patients diagnosed by pathology with gastrointestinal stromal tumor (GIST); 4. The proportion of tumor cells evaluated by pathology is not less than 20%. Inclusion criteria for the control group (in line with 5): 5. Benign tumor or inflammatory tissue after pathological diagnosis.

Exclusion criteria

Exclusion criteria: 1. Patients not conforming to the pathological diagnosis of non-small cell lung cancer (NSCLC) or colorectal cancer (CRC) or gastrointestinal stromal tumor (GIST); 2. The proportion of pathologically assessed tumor cells was less than 20%; 3. The preservation time of samples after collection is more than 24 months when the samples are enrolled; 4. Tissue samples cannot meet the detection requirements (such as insufficient wax samples, wax block loss, etc.); 5. Repeated sampling for the same case; 6. Out of number of cases (competitive entry); 7. Sample information is incomplete and non-standard, such as lack of traceability key information, unclear diagnostic information, etc.

Design outcomes

Primary

MeasureTime frame
Lung and gastrointestinal tumor genes;

Countries

China

Contacts

Public ContactTang Yuan

West China Hospital, Sichuan University

1202ty@163.com+86 18980601646

Outcome results

None listed

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