Electrochemical Biosensor Based on Lectin-functionalized Nitrogen, Sulfur-doped Graphene Quantum Dot Decorated Gold Nanoparticles for Breast Cancer Diagnosis: From Academic Research to Clinical Translation
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observational
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Brief Summary
In this research, considering benefits of the nitrogen, sulfur-doped graphene quantum dot (NSGQDs) and 3-dimensional gold nanoparticle (AuNP), we used these materials for the construction of a novel electrochemical biosensor to apply the synergy contributions on the enhancement of the potential in clinical and cancer diagnostic applications. The synthesis of a novel nanocomposite through the integration of NSGQDs with AuNP yields a hybrid material (NSGQDs/AuNP) that combines the advantages of both its organic and inorganic properties, potentially revealing unique characteristics to enhance the electrochemical behaviors, which establishes a robust foundation for constructing a label-free electrochemical biosensor. This pioneering biosensor was then conjugated with PhaL (NSGQDs/AuNP/PhaL) through the amide bond between the COOH group of NSGQDs and the NH2 group of PhaL, which has the potential for the ultra-sensitive detection of cancer markers, featuring heightened electrochemical and sensing capabilities that make substantial contributions to the field of cancer detection. The detection principle of breast cancer is based on the change in impedance of NSGQDs/AuNP/PhaL after the addition of breast cancer cell, which can inhibit the electron transfer after the formation of breast cancer cell bioconjugate with NSGQDs/AuNP/PhaL. NSGQDs/AuNP/PhaL are used as the bi-functional probe to amplify the electrochemical activity as well as to link cancer cell. The developed novel NSGQDs/AuNP/PhaL biosensor show high sensitivity and good stability for quantitative determination of breast cancer cell in a linear range of 5 - 2500 cell mL-1 with limit of detection (LOD) of 6 cancer cell mL-1, which exhibits a great potential in clinical and cancer diagnostic applications. The superior sensitivity of the developed impedimetric immunosensor is mainly attributed to the remarkable electro-conductivity of NSGQDs/AuNP, which can accelerate the electron transfer process between NSGQDs/AuNP/PhaL and electrolyte. This achievement paves the way for the development of a lectin-based sensing probe as a robust platform for the ultrasensitive and selective detection of MCF-7 and other cancer cell lines. Such advancements hold significant promise for facilitating early diagnosis and therapy of diseases, particularly in the context of breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2025
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2025
CompletedFirst Posted
Study publicly available on registry
June 24, 2025
CompletedStudy Start
First participant enrolled
July 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2030
July 18, 2025
March 1, 2025
5 years
June 15, 2025
July 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sensitivity and selectivity on electrochemical biosensor
The detection principle of breast cancer is based on the change in impedance of NSGQDs@AuNP after the addition of breast cancer cell, which can inhibit the electron transfer after the formation of breast cancer cell bioconjugate on the NSGQDs/AuNP surface. NSGQDs and NSGQDs/AuNP are fabricated by the hydrothermal pyrolysis and reduction methods, respectively. NSGQDs/AuNP are used as the bi-functional probe to amplify the electrochemical activity as well as to link cancer cell. The developed novel NSGQDs@AuNP nanocomposites show high sensitivity and good stability for quantitative determination of breast cancer cell in a linear range of 5 - 2500 cell mL-1 with limit of detection (LOD) of 6 cell mL-1
From enrollment to the following 3 years
Study Arms (2)
control
healthy donors
experimental
breast cancer participants
Interventions
considering benefits of the nitrogen, sulfur-doped graphene quantum dot (NSGQDs) and 3-dimensional gold nanoparticle (AuNP), we used these materials for the construction of a novel electrochemical biosensor to apply the synergy contributions on the enhancement of the potential in clinical and cancer diagnostic applications. The synthesis of a novel nanocomposite through the integration of NSGQDs with AuNP yields a hybrid material (NSGQDs/AuNP) that combines the advantages of both its organic and inorganic properties, potentially revealing unique characteristics to enhance the electrochemical behaviors, which establishes a robust foundation for constructing a label-free electrochemical biosensor. This pioneering biosensor was then conjugated with PhaL (NSGQDs/AuNP/PhaL) through the amide bond between the COOH group of NSGQDs and the NH2 group of PhaL, which has the potential for the ultra-sensitive detection of cancer markers, featuring heightened electrochemical and sensing capabilitie
Eligibility Criteria
The study will be conducted in two branch hospitals of Chang Gung Memorial Hospital, Taiwan including Linkou and Tucheng. Healthy and breast cancer participants.
You may qualify if:
- age 18-90
- health participants: without cancer over 5 years
- cancer participants: diagnosis of breast cancer
- cancer participants: agree to receive treatment in Chang Gung hospital
You may not qualify if:
- mental disease
- Physician's assessment not suitable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
CHIA-HSUN Hsieh, M.D PhD
Chang Gung Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2025
First Posted
June 24, 2025
Study Start
July 20, 2025
Primary Completion (Estimated)
July 31, 2030
Study Completion (Estimated)
July 31, 2030
Last Updated
July 18, 2025
Record last verified: 2025-03