Status:
UNKNOWN
Assessment of Early-detection Based on Liquid Biopsy in Lung Cancer (ASCEND-LUNG)
Lead Sponsor:
Peking University People's Hospital
Conditions:
Lung Cancer
Eligibility:
All Genders
40-74 years
Brief Summary
The purpose of this study is to develop a lung cancer diagnosis tool using a multi-omics approach based on liquid biopsy.
Detailed Description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening process to determine eligibility of study entry. Peripheral blood, tissu...
Eligibility Criteria
Inclusion
- Signed informed consent
- Male or female, age equal to or greater than 40 years old and less than 75 years old
- Blood sample was collected before surgery for the detection of cfDNA methylation and other biomarkers
- Lung cancer patients diagnosed for the first time within 42 days before blood sampling without any anti-tumor treatment; or patients who are highly suspected of lung cancer through imaging evaluation or other routine clinical diagnosis and confirmed by tissue biopsy or surgical specimens within 42 days after blood sampling
- The subject has not received any local or systemic anti-tumor therapy before blood collection, including (not limited to) any surgery, local or systemic radiotherapy and chemotherapy, targeted therapy (including anti-angiogenesis), immunotherapy, cancer vaccines and hormone therapy, etc.
Exclusion
- Unable to obtain sufficient and qualified blood samples
- Female subjects who are pregnant or breastfeeding
- Patients who have received organ transplantation or non-autologous bone marrow or stem cell transplantation
- Patients who have received blood transfusion within 7 days before blood sampling
- Patients who have received anti-infection treatment within 14 days before blood collection
- Patients who have receiving anti-tumor drugs for other diseases within 30 days before blood collection, such as methotrexate, cyclophosphamide, mercaptopurine, chlorambucil, tamoxifen, etc.
- Patients who suffered from other malignant tumors or multiple primary tumors at the same time
- Pathological confirmed benign lesions by tissue biopsy or surgery
- Insufficient sample for a confirmed pathological diagnosis
- Lung cancer patients with ground glass nodules on CT imaging.
Key Trial Info
Start Date :
February 19 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
467 Patients enrolled
Trial Details
Trial ID
NCT04817046
Start Date
February 19 2021
End Date
December 31 2024
Last Update
March 25 2021
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044