Assessment of Early-detection Based on Liquid Biopsy in Lung Cancer (ASCEND-LUNG)

Lung Cancer Clinical Trial

Official title:

Detection of Early-stage Lung Cancer Based on Liquid Biopsy of Peripheral Blood: a Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04817046
• Other study ID #: PTHO2101
• Status: Recruiting
• Start date: February 19, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2021
• Source: Peking University People's Hospital
• Contact: Kezhong Chen, MD
• Phone: 08601088326650
• Email: chenkezhong[@]pkuph.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to develop a lung cancer diagnosis tool using a multi-omics approach based on liquid biopsy.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 467
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of the multi-omics early-stage lung cancer diagnosis model	Sensitivity and specificity of the multi-omics early-stage lung cancer diagnosis model	through study completion, an average of 1.5 year
Secondary	Accuracy of diagnostic models established separately from multi-omics data	Sensitivity and specificity models established separately from multi-omics data	through study completion, an average of 1.5 year
Secondary	Relationship between multi-omics data	Explore the relationship of features extracted from multi-omics data	through study completion, an average of 1.5 year