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

NCT04817046 | Unknown

• 1 other identifier: PTHO2101
• Study Type: observational
• Target: 467
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Cancer

Keywords

Liquid Biopsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Accuracy of diagnostic models established separately from multi-omics data

  through study completion, an average of 1.5 year

• Relationship between multi-omics data

  through study completion, an average of 1.5 year

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed lung cancer patients between 40-75 years old, with solid nodule on CT imaging.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (1)

• Jin Y, Mu W, Shi Y, Qi Q, Wang W, He Y, Sun X, Yang B, Cui P, Li C, Liu F, Liu Y, Wang G, Zhao J, Zhang Y, Zhang S, Cao C, Sun C, Hong N, Cai S, Tian J, Yang F, Chen K. Development and validation of an integrated system for lung cancer screening and post-screening pulmonary nodules management: a proof-of-concept study (ASCEND-LUNG). EClinicalMedicine. 2024 Aug 3;75:102769. doi: 10.1016/j.eclinm.2024.102769. eCollection 2024 Sep.

  PMID: 39165498 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Tissue and peripheral blood will be collected. Tissue DNA and cell-free DNA will be extracted for genetic analysis.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Fan Yang, MD

  Peking University People's Hospital

  STUDY CHAIR

Central Study Contacts

Kezhong Chen, MD

CONTACT

08601088326650; chenkezhong@pkuph.edu.cn

Fan Yang, MD

CONTACT

08601088326650; yangfan@pkuph.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 25, 2021
• Study Start: February 19, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2024
• Last Updated: March 25, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)