Non-small Cell Lung Cancer With Central Nervous System Metastasis

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06026735
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 58.6
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Cerebrospinal fluid was obtained from the cerebrospinal cavity of non-small cell lung cancer patients with central nervous system metastasis, blood was obtained from veins, and metastatic lung cancer tumor tissue was obtained from surgically resected brain tumors or meningeal tumors. Then comprehensively analyze the exosomes contained in the aforementioned samples, and compare and analyze the clinical data of the patients, so as to explore whether the cancer cell-related substances contained in the cerebrospinal fluid, blood and tumor tissue can be used to predict lung cancer metastasis and Bioindicators of treatment effect.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer With Central Nervous System Metastasis	Other: lung cancer with brain /leptomeningeal metastasis

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Comprehensive Profiling of Promising Biomarkers in Exosomes From Non-small Cell Lung Cancer With Central Nervous System Metastasis
• Actual Study Start Date: Jan 13, 2023
• Anticipated Primary Completion Date: Dec 1, 2027
• Anticipated Study Completion Date: Dec 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
lung cancer with brain metastasis	Other: lung cancer with brain /leptomeningeal metastasis; Cerebrospinal fluid was obtained from the cerebrospinal cavity of non-small cell lung cancer patients with central nervous system metastasis, blood was obtained from veins, and metastatic lung cancer tumor tissue was obtained from surgically resected brain tumors or meningeal tumors. Then comprehensively analyze the exosomes contained in the aforementioned samples, and compare and analyze the clinical data of the patients, so as to explore whether the cancer cell-related substances contained in the cerebrospinal fluid, blood and tumor tissue can be used to predict lung cancer metastasis and Bioindicators of treatment effect.
lung cancer with leptomeningeal metastasis	Other: lung cancer with brain /leptomeningeal metastasis; Cerebrospinal fluid was obtained from the cerebrospinal cavity of non-small cell lung cancer patients with central nervous system metastasis, blood was obtained from veins, and metastatic lung cancer tumor tissue was obtained from surgically resected brain tumors or meningeal tumors. Then comprehensively analyze the exosomes contained in the aforementioned samples, and compare and analyze the clinical data of the patients, so as to explore whether the cancer cell-related substances contained in the cerebrospinal fluid, blood and tumor tissue can be used to predict lung cancer metastasis and Bioindicators of treatment effect.

Outcome Measures

Primary Outcome Measures

1. predict lung cancer metastasis and Bioindicators of treatment effect [follow 3 years]

   Cerebrospinal fluid was obtained from the cerebrospinal cavity of non-small cell lung cancer patients with central nervous system metastasis, blood was obtained from veins, and metastatic lung cancer tumor tissue was obtained from surgically resected brain tumors or meningeal tumors. Then comprehensively analyze the exosomes contained in the aforementioned samples, and compare and analyze the clinical data of the patients, so as to explore whether the cancer cell-related substances contained in the cerebrospinal fluid, blood and tumor tissue can be used to predict lung cancer metastasis and Bioindicators of treatment effect.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. Non-small cell lung cancer patients diagnosed with brain metastases or meningeal metastases on brain computed tomography (CT) or magnetic resonance (MRI) images.

1. Patients with non-small cell lung cancer who are about to undergo surgical brain surgery, such as brain tumor resection, lumbar abdominal drainage, Euclidean storage, or ventriculoperitoneal drainage.

Exclusion Criteria:

• 1. Non-small cell lung cancer patients without brain metastases or meningeal metastases.

1. Physical condition does not allow surgical removal of the tumor.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan	100

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT06026735
• Other Study ID Numbers: 202209032RINB
• First Posted: Sep 7, 2023
• Last Update Posted: Sep 7, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Neoplasm Metastasis

Study Results

No Results Posted as of Sep 7, 2023