Clinical trial NCT04326751: Evolution of Multiple Primary Lung Cancer (Evolution)
Official title: The Genetic Evolution and Microenvironment of Multiple Primary Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Primary Lung Cancers
Lung Cancer
Non Small Cell Lung Cancer
Keywords: multiple primary lung cancer
ctDNA
evolution
tumor heterogeneity
microenvironment
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Guangzhou Burning Rock Medical Examination Institute Co., Ltd.
First posted: 2020-03-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Histologically confirmed multiple lung cancer patients who will receive surgical therapy

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tumor heterogeneity of multiple primary lung cancer
timeFrame: 3 year
measure: Microenvironment of multiple primary lung cancer
timeFrame: 3 year
Secondary outcomes:
measure: Correlation between ctDNA and clonal variation
timeFrame: 3 year
measure: Correlation between ctDNA and tumor burden
timeFrame: 3 year
Other outcomes:
Locations:
Study officials:
affiliation: Peking University People's Hospital Thoracic Surgery Department
name: Jun Wang, M.D.
role: STUDY_CHAIR
References: