Evolution of Multiple Primary Lung Cancer (Evolution)

• ClinicalTrials.gov Identifier: NCT04326751
• Recruitment Status: Unknown
• First Posted: March 30, 2020
• Last Update Posted: March 30, 2020
• Sponsor: Peking University People's Hospital
• Collaborator: Guangzhou Burning Rock Medical Examination Institute Co., Ltd.
• Information provided by (Responsible Party): Peking University People's Hospital

Tracking Information

• First Submitted Date: March 26, 2020
• First Posted Date: March 30, 2020
• Last Update Posted Date: March 30, 2020
• Estimated Study Start Date: January 1, 2021
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 26, 2020)

• 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.
• 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: March 26, 2020)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evolution of Multiple Primary Lung Cancer (Evolution)
• Official Title: The Genetic Evolution and Microenvironment of Multiple Primary Lung Cancer
• 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.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

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.

• Sampling Method: Non-Probability Sample
• Study Population: Histologically confirmed multiple lung cancer patients who will receive surgical therapy

Condition

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

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 26, 2020): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2023
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04326751
• Other Study ID Numbers: PTHO2002
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Peking University People's Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Peking University People's Hospital
• Original Study Sponsor: Same as current
• Collaborators: Guangzhou Burning Rock Medical Examination Institute Co., Ltd.

Investigators

• Study Chair: Jun Wang, M.D.; Peking University People's Hospital Thoracic Surgery Department

• PRS Account: Peking University People's Hospital
• Verification Date: March 2020