Evolution of Multiple Primary Lung Cancer (Evolution)
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ClinicalTrials.gov Identifier: NCT04326751 |
Recruitment Status : Unknown
Verified March 2020 by Peking University People's Hospital.
Recruitment status was: Not yet recruiting
First Posted : March 30, 2020
Last Update Posted : March 30, 2020
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Condition or disease |
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Multiple Primary Lung Cancers Lung Cancer Non Small Cell Lung Cancer |
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 |
- 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.
- 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.
Biospecimen Retention: Samples With DNA
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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 |
Inclusion Criteria:
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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.
Exclusion Criteria:
- 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
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
Contact: Kezhong Chen, M.D. | (+86)13488752289 | mdkzchen@163.com |
Study Chair: | Jun Wang, M.D. | Peking University People's Hospital Thoracic Surgery Department |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
multiple primary lung cancer ctDNA evolution tumor heterogeneity microenvironment |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |