Non-small cell lung cancer/colorectal cancer/gastrointestinal stromal tumor/stomach cancer/glioma/thyroid cancer/breast cancer/ovarian cancer/melanoma/cholangiocarcinoma/urothelial carcinoma/prostate
Conditions
Interventions
Gold Standard:Reference methods: 1. Total exome sequencing (WES) 2. Multiple fluorescence PCR capillary electrophoresis (PCR-STR)
Comparison method: comparison of similar kits
Index test:Information of reagents to be examined: (1) Product name: Human solid Tumor Multi-gene Mutation Combined Detection Kit (high-throughput sequencing method)
(2) Packing specification: 48 test/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
Peking Union Medical College Hospita
Eligibility
Sex/Gender
All
Age
No minimum to 100 Years
Inclusion criteria
Inclusion criteria: 1. Accuracy research test: Single tumor tissue sample group 1) Tumor tissue samples from patients with non-small cell lung cancer, colorectal cancer, gastrointestinal stromal tumor, gastric cancer, glioma, thyroid cancer, breast cancer, ovarian cancer, melanoma, cholangiocarcinoma, urothelial carcinoma and prostate cancer were confirmed by pathological diagnosis. 2) The proportion of tumor tissue samples assessed by pathology was not less than 20%. Tumor tissue paired with paracancer sample Group 1) Tumor tissue samples and paracancer tissue samples from patients with solid tumors confirmed by pathological diagnosis, including but not limited to non-small cell lung cancer, colorectal cancer, gastrointestinal stromal tumor, gastric cancer, glioma, thyroid cancer, breast cancer, ovarian cancer, melanoma, cholangiocarcinoma, urothelial carcinoma and prostate cancer. 2) The paired tumor tissue samples were from patients with the same tumor; 3) The proportion of matched tumor tissue samples was not less than 20% after pathological evaluation. 4) The proportion of tumor tissue in paired paracancer tissue samples assessed by pathology should be 0%. Tumor tissue paired with peripheral blood sample group 1)Tumor tissue samples and peripheral blood samples from patients with solid tumors confirmed by pathological diagnosis, including but not limited to non-small cell lung cancer, colorectal cancer, gastrointestinal stromal tumor, gastric cancer, glioma, thyroid cancer, breast cancer, ovarian cancer, melanoma, cholangiocarcinoma, urothelial carcinoma and prostate cancer. 2) The paired tumor tissue samples were from patients with the same tumor; 3)The proportion of matched tumor tissue samples was not less than 20% after pathological evaluation. 4) No less than 1mL matching peripheral blood samples; 5) If paired peripheral blood samples are not collected retrospectively, subjects' informed consent shall be signed to collect peripheral blood (if applicable); Interference group (accord with ??? or ???) 1) Tumor tissue samples and paratumoral tissue samples or normal tissue samples of patients with benign lesions confirmed by pathological diagnosis; 2) Tumor tissue samples and paracancer tissue samples or normal tissue samples of patients with small cell lung cancer confirmed by pathological diagnosis; 3) The proportion of tumor tissue was not less than 20% after pathological evaluation. 4) The proportion of tumor cells in paired tumor/paracancer tissue or normal tissue samples assessed by pathology was 0%; 2. Clinical validation tests for accompanying diagnostic purposes: 1) Tumor tissue samples from patients with non-small cell lung cancer, colorectal cancer, breast cancer and melanoma confirmed by pathological diagnosis; 2) The proportion of tumor tissue samples assessed by pathology was not less than 20%.
Exclusion criteria
Exclusion criteria: 1. Accuracy research test: 1) The collection time of samples is not clear or the samples cannot be traced; 2) Samples that do not meet the requirements for sample collection and preservation; 3) The collected samples cannot meet the detection requirements (such as insufficient tissue wax samples, tissue wax loss, etc.); Insufficient residual blood sample etc.); 4) Repeated inclusion of the same type of samples from the same case; 5) the number of cases exceeding the total sample size (each center competed for inclusion); 6) Samples that cannot be traced due to lack of sample information or related records; 7) The sample label information is inconsistent with the system data. 2. Clinical validation tests for accompanying diagnostic purposes: 1) The collection time of samples is not clear or the samples cannot be traced; 2) Samples that do not meet the requirements for sample collection and preservation; 3) The collected samples cannot meet the detection requirements (such as insufficient tissue wax samples, tissue wax loss, etc.); 4) Repeated inclusion of the same type of samples from the same case; 5) The number of cases exceeding the total sample size (each center competed for inclusion); 6) Samples that cannot be traced due to lack of sample information or related records; 7) The sample label information is inconsistent with the system data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-small cell lung cancer/colorectal cancer/gastrointestinal stromal tumor/stomach cancer/glioma/thyroid cancer/breast cancer/ovarian cancer/melanoma/cholangiocarcinoma/urothelial carcinoma/prostate cancer/other malignant solid tumor genes; | — |
Countries
China
Contacts
Public ContactTang Yuan
West China Hospital,Sichuan University
Outcome results
None listed