Small Cell Lung Cancer
Conditions
Interventions
Gold Standard:Pathological diagnosis and/or clinical diagnosis (staging) results
Index test:cfDNA methylation-based model
Multi omics early screening model for small cell lung cancer
Sponsors
ShangHai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Clinically and/or pathologically diagnosed SCLC 2. 40-75 years old 3. No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, cell therapy, interventional therapy, etc. 4. Able to provide a written informed consent and willing to comply with the sampling, evaluation, and visit requirements of this study
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactating women 2. Prior diagnosis of other types of malignancies comorbidities 3. Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of = 38.0 °C) within 14 days prior to blood draw 4. Recipients of therapy in past 14 days prior to blood draw, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamine, hydrazine, arsenic trioxide 5. Recipients of organ transplant or bone marrow transplant or stem cell transplant prior to study blood draw. Recipients of blood transfusion within 30 days 6.Unsuitable to attend the study considered by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sensitivity of cfDNA methylation-based model;The specificity of cfDNA methylation-based model;The AUC of cfDNA methylation-based model; | — |
Secondary
| Measure | Time frame |
|---|---|
| The performance of models using multi-omics data;The sensitivity and specificity of predefined model in different clinical sub-groups (such as age, gender, clinical stage, etc.); | — |
Countries
China
Contacts
Public ContactCaicun Zhou
ShangHai Pulmonary Hospital
Outcome results
None listed