Evaluation ctDNA in Patients of Non-Small-Cell Lung Cancer Following Resection (EVOLUTION)
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ClinicalTrials.gov Identifier: NCT04238130 |
Recruitment Status : Unknown
Verified January 2020 by Si-Yu Wang, Sun Yat-sen University.
Recruitment status was: Recruiting
First Posted : January 23, 2020
Last Update Posted : February 5, 2020
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Condition or disease | Intervention/treatment |
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Non-Small Cell Lung Cancer | Diagnostic Test: Perioperative ctDNA Dynamic Monitoring |
Study Type : | Observational |
Estimated Enrollment : | 200 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Evaluation Perioperative Dynamic Changes in ctDNA From Patients of Non-Small-Cell Lung Cancer Following Resection for Relapse Prediction |
Actual Study Start Date : | December 18, 2019 |
Estimated Primary Completion Date : | December 18, 2022 |
Estimated Study Completion Date : | June 30, 2023 |
Group/Cohort | Intervention/treatment |
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Perioperative ctDNA Dynamic Monitoring Group
Samples were obtained at multiple pre-specified time points including before surgery (plasma samples),during surgery after tumor resection (tumor samples) and after surgery(plasma samples were obtained every 6 months from ctDNA positive patients at baseline in the following 2 years)
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Diagnostic Test: Perioperative ctDNA Dynamic Monitoring
To apply ctDNA dynamic monitoring in early stage NSCLC patients with driver mutations positive at baseline |
- Concordance between genomic alterations assessed by next-generation sequencing in tumor tissue and PEAC technology in circulating tumor DNA [ Time Frame: 2 years after the last patient enrolled ]PEAC (Personalized Analysis of Cancer) technology was performed to detect the driver gene mutations from plasma samples and matched tumor tissue samples were detected by NGS platform at baseline.
- ctDNA dynamic monitoring [ Time Frame: 2 years after the last patient enrolled ]PEAC technology was performed to apply ctDNA dynamic monitoring in early stage NSCLC patients with driver mutations positive at baseline
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Postoperative histopathological diagnosis of TNM stage I to III NSCLC with R0 resection;
- No adjuvant chemotherapy, radiotherapy, targeted drug therapy or biotherapy after surgery;
- Men or women of age ≥18 years and <75 years old;
- Eastern Cooperative Oncology Group (ECOG) behavior status score 0 to 1.
Exclusion Criteria:
- Patients with other cancers other than NSCLC within five years prior to this study;
- Who can not get enough tumor histological specimens (non-cytological) for analysis;
- Human immunodeficiency virus (HIV) infection;
- NSCLC mixed with patients with small cell lung cancer;
- Pregnant or lactating women;
- There is a clear history of neurological or mental disorders, including epilepsy or dementia;
- Conditions that investigators think is not suitable for inclusion.
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): NCT04238130
Contact: Si-Yu Wang, MD | +86 20 87343439 | wsysums@163.net |
China, Guangdong | |
Sun Yat-sen University Cancer Center | Recruiting |
Guangzhou, Guangdong, China, 510060 | |
Contact: Si-Yu Wang, Doctor +86 20 87343439 wsysums@163.net | |
Principal Investigator: Si-Yu Wang, Professor |
Principal Investigator: | Si-Yu Wang, MD | Sun Yat-sen University |
Responsible Party: | Si-Yu Wang, Professor, Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT04238130 |
Other Study ID Numbers: |
GASTO1058 |
First Posted: | January 23, 2020 Key Record Dates |
Last Update Posted: | February 5, 2020 |
Last Verified: | January 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Non-Small Cell Lung Cancer (NSCLC) Resectable Dynamic Monitoring PEAC |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |