Evolution of Multiple Primary Lung Cancer (Evolution)

NCT04326751 | Unknown

• 1 other identifier: PTHO2002
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate the evolutionary genomic landscape, explore the genetic tumor heterogeneity and microenvironment of multiple primary lung cancer (MPLC) by using tissue genetic analysis and circulating tumor DNA detection, in order to provide robust evidence for the diagnosis, treatment, and surveillance of MPLC.

Conditions

Multiple Primary Lung Cancers; Lung Cancer; Non Small Cell Lung Cancer

Keywords

multiple primary lung cancer; ctDNA; evolution; tumor heterogeneity; microenvironment

Outcome Measures

Primary Outcomes (2)

• Tumor heterogeneity of multiple primary lung cancer

  Explore the intra-tumor and inter-tumor genetic heterogeneity by analysis of clonal and subclonal mutations detected by ctDNA.

  3 year

• Microenvironment of multiple primary lung cancer

  Using RNA sequencing and T cell receptor (TCR) sequencing to evaluate the microenvironment of each lesion of multiple primary lung cancer, including T cell receptpr clonality ,diversity , evenness, and richness.

  3 year

Secondary Outcomes (2)

• Correlation between ctDNA and clonal variation

  3 year

• Correlation between ctDNA and tumor burden

  3 year

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Histologically confirmed multiple lung cancer patients who will receive surgical therapy

You may qualify if:

• Aged 18 to 80 years
• Patients who are clinically diagnosed multiple lung cancers, and undergo surgical treatment.
• No history of any malignancy in recent 5 years.
• No chemotherapy, radiotherapy or targeted therapy will be performed before surgery.
• Surgical removal of at least 2 tumors confirmed to be lung cancer postoperatively by pathologic evaluation.

You may not qualify if:

• All lesions present as pure ground-glass opacities (GGOs) on CT scans.
• Patients who do not undergo R0 resection (including tumors located bilaterally but only unilaterally resected).
• Unqualified blood samples.
• Unable to comply with the study procedure

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Guangzhou Burning Rock Medical Examination Institute Co., Ltd.: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Fresh tumor tissue and blood samples were collected from each patient. Time for blood sample collection: 1) Preoperation. 2) The 1st to 3rd day of postoperation.

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Jun Wang, M.D.

  Peking University People's Hospital Thoracic Surgery Department

  STUDY CHAIR

Central Study Contacts

Kezhong Chen, M.D.

CONTACT

(+86)13488752289; mdkzchen@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 30, 2020
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 30, 2020

Record last verified: 2020-03