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Evolution of Multiple Primary Lung Cancer (Evolution)

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ClinicalTrials.gov Identifier: NCT04326751
Recruitment Status : Not yet recruiting
First Posted : March 30, 2020
Last Update Posted : March 30, 2020
Guangzhou Burning Rock Medical Examination Institute Co., Ltd.
Information provided by (Responsible Party):
Peking University People's Hospital

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.

Condition or disease
Multiple Primary Lung Cancers Lung Cancer Non Small Cell Lung Cancer

Detailed Description:
Multiple primary lung cancer (MPLC) has become a worldwide problem due to the difficulty in diagnosis, treatment and surveillance. Although exploring tumour clonal heterogeneity and microenvironment can help understand cancer evolution and impact therapeutic outcome, study is still lacking in this field on MPLC. Circulating tumor DNA (ctDNA) are short DNA fragments, which can be obtained conveniently and non-invasively, providing comprehensive views of the tumor as were shed by tumor cells from multiple tumor regions. Therefore, we design a prospective study of patients with surgically treated MPLC, aiming to use ctDNA technique to define the evolutionary landscape of MPLC through inter-tumor and intra-tumor heterogeneity by multi-region sampling and genetic analysis. We will also explore the the microenvironment by RNA sequencing and T cell receptor sequencing. This study may help understand the genetic evolution and microenvironment of MPLC, and provide evidence for the diagnosis, treatment and surveillance of these patients.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Genetic Evolution and Microenvironment of Multiple Primary Lung Cancer
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  1. Tumor heterogeneity of multiple primary lung cancer [ Time Frame: 3 year ]
    Explore the intra-tumor and inter-tumor genetic heterogeneity by analysis of clonal and subclonal mutations detected by ctDNA.

  2. Microenvironment of multiple primary lung cancer [ Time Frame: 3 year ]
    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.

Secondary Outcome Measures :
  1. Correlation between ctDNA and clonal variation [ Time Frame: 3 year ]
    Explore the correlation between the detection rate of ctDNA and subclonal mutations of different tumor sites detected by genetic analysis.

  2. Correlation between ctDNA and tumor burden [ Time Frame: 3 year ]
    Explore the correlation between the detection rate of ctDNA and tumor burden.

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.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Histologically confirmed multiple lung cancer patients who will receive surgical therapy

Inclusion Criteria:

  • Aged 18 to 80 years

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04326751

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Contact: Kezhong Chen, M.D. (+86)13488752289 mdkzchen@163.com

Sponsors and Collaborators
Peking University People's Hospital
Guangzhou Burning Rock Medical Examination Institute Co., Ltd.
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Study Chair: Jun Wang, M.D. Peking University People's Hospital Thoracic Surgery Department
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Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT04326751    
Other Study ID Numbers: PTHO2002
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking University People's Hospital:
multiple primary lung cancer
tumor heterogeneity
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases