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Status unknownNCT04326751Updated Mar 30, 2020

Evolution of Multiple Primary Lung Cancer (Evolution)

An observational study in Multiple Primary Lung Cancers, Lung Cancer and Non Small Cell Lung Cancer, sponsored by Peking University People's Hospital. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-03-30.

Sponsored by Peking University People's Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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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Conditions studied

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

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Keywords

  • multiple primary lung cancer
  • ctDNA
  • evolution
  • tumor heterogeneity
  • microenvironment
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 20 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 year

  2. 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.

    Time frame: 3 year

Secondary outcomes

  1. Correlation between ctDNA and clonal variation

    Explore the correlation between the detection rate of ctDNA and subclonal mutations of different tumor sites detected by genetic analysis.

    Time frame: 3 year

  2. Correlation between ctDNA and tumor burden

    Explore the correlation between the detection rate of ctDNA and tumor burden.

    Time frame: 3 year

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04326751
Lead sponsor
Peking University People's Hospital
Collaborators
Guangzhou Burning Rock Medical Examination Institute Co., Ltd.
Responsible party
Sponsor
First posted
Mar 30, 2020
Start date
Jan 1, 2021 (estimated)
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Mar 30, 2020

Study contacts

Kezhong Chen, M.D.
Contact
mdkzchen@163.com
(+86)13488752289
Jun Wang, M.D.
study chair · Peking University People's Hospital Thoracic Surgery Department

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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