Clinical Sensitivity Verification Study of Circulating Tumor Cells Gene Mutation Detection From Advanced NSCLC Patients

NCT04229121 | Unknown

• 1 other identifier: CTC-FM
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Verify the Coincidence rate between Circulating tumor cells (CTCs) and tumor tissue or Circulating tumor DNA (ctDNA) of advanced NSCLC patients with Driver gene mutation

Conditions

Advanced NSCLC; Circulating Tumor Cells; Circulating Tumor DNA

Outcome Measures

Primary Outcomes (2)

• Driver gene mutation frequency from CTCs of advanced NSCLC patients

  Analyze the driver gene mutation frequency in CTCs from advanced NSCLC patients with tumor tissue driver gene mutation

  6 months

• The gene mutation coincidence rate between CTCs and tumor tissue sample

  Comparison the gene mutation coincidence rate between CTCs and tumor tissue sample

  6 months

Secondary Outcomes (2)

• Driver gene mutation frequency from ctDNA of advanced NSCLC patients

  6 months

• The gene mutation coincidence rate between CTCs and ctDNA

  6 months

Study Arms (2)

Driver gene mutation-positive

Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a Driver gene mutation positive.

Other: nonintervention

Driver gene mutation-negative

Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a Driver gene mutation negative.

Other: nonintervention

Interventions

nonintervention OTHER

nonintervention

Driver gene mutation-negative; Driver gene mutation-positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Histologially or cytologically proven diagnosis of advanced NSCLC

You may qualify if:

• Female or male, 18 years of age or older
• Histologically or cytologically proven diagnosis of advanced NSCLC patients without any target therapy or chemotherapy
• Able to get tumor tissue gene (EGFR/ALK/ROS1/RET/MET skipping) testing results by Lung cancer Polymerase Chain Reaction (PCR) panel kit carried out in hospital
• Signed and dated informed consent

You may not qualify if:

• Combine with other tumor type
• The investigator judges the situation that may affect the clinical search process and results

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Related Publications (3)

• Haber DA, Velculescu VE. Blood-based analyses of cancer: circulating tumor cells and circulating tumor DNA. Cancer Discov. 2014 Jun;4(6):650-61. doi: 10.1158/2159-8290.CD-13-1014. Epub 2014 May 6.

  PMID: 24801577 BACKGROUND

• Li Y, Xu H, Su S, Ye J, Chen J, Jin X, Lin Q, Zhang D, Ye C, Chen C. Clinical validation of a highly sensitive assay to detect EGFR mutations in plasma cell-free DNA from patients with advanced lung adenocarcinoma. PLoS One. 2017 Aug 22;12(8):e0183331. doi: 10.1371/journal.pone.0183331. eCollection 2017.

  PMID: 28829813 BACKGROUND

• Krebs MG, Metcalf RL, Carter L, Brady G, Blackhall FH, Dive C. Molecular analysis of circulating tumour cells-biology and biomarkers. Nat Rev Clin Oncol. 2014 Mar;11(3):129-44. doi: 10.1038/nrclinonc.2013.253. Epub 2014 Jan 21.

  PMID: 24445517 BACKGROUND

MeSH Terms

Conditions

Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yayi He, MD,PHD

  Shanghai Pulmonary Hospital, Tongji University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yayi He, MD,PHD

CONTACT

+862165115006; 2250601@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Head of Medical Oncology

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 18, 2020
• Study Start: January 15, 2020
• Primary Completion: June 15, 2020
• Study Completion: December 15, 2020
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share