Clinical trial NCT04817046: Assessment of Early-detection Based on Liquid Biopsy in Lung Cancer (ASCEND-LUNG)
Official title: Detection of Early-stage Lung Cancer Based on Liquid Biopsy of Peripheral Blood: a Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: Liquid Biopsy
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 467
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed lung cancer patients between 40-75 years old, with solid nodule on CT imaging.

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, tissue sample and imaging examinations of eligible patients will be collected for further analysis. Data collected will be used to develop a multi-omics lung cancer diagnosis model.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Accuracy of the multi-omics early-stage lung cancer diagnosis model
timeFrame: through study completion, an average of 1.5 year
Secondary outcomes:
measure: Accuracy of diagnostic models established separately from multi-omics data
timeFrame: through study completion, an average of 1.5 year
measure: Relationship between multi-omics data
timeFrame: through study completion, an average of 1.5 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Fan Yang, MD
role: STUDY_CHAIR
References: