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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    467
  • sponsor
    Peking University People's Hospital
Updated on 1 April 2021

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.

Details
Condition Pulmonary Disease, Lung Disease, Lung Neoplasm, Lung Cancer, Bronchial Neoplasm, Lung Cancer, Lung Disease, carcinoma lung, lung carcinoma
Clinical Study IdentifierNCT04817046
SponsorPeking University People's Hospital
Last Modified on1 April 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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