NCT07034248

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

Not yet recruiting Last updated 18 July 2025

What this trial tests

trial testing Electrochemical biosensor in Electrochemically Sensing Prob in 240 participants. Not yet recruiting.

Timeline

20 July 2025

Primary endpoint
31 July 2030

31 July 2030

Quick facts

Lead sponsor	Chang Gung Memorial Hospital
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	240
Start date	20 July 2025
Primary completion	31 July 2030
Estimated completion	31 July 2030

Drugs / interventions tested

• Electrochemical biosensor

Conditions studied

• Electrochemically Sensing Prob — all drugs for Electrochemically Sensing Prob →
• Breast Cancer Diagnosis — all drugs for Breast Cancer Diagnosis →

Sponsor

Chang Gung Memorial Hospital

Who can join

Adults 18 to 90, any sex, with Electrochemically Sensing Prob or Breast Cancer Diagnosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advances in the Application of Graphene and Its Derivatives in Drug Delivery Systems.
   Jin C, Zheng H, Chen J. · · 2025 · cited 2× · PMID 41011116 · DOI 10.3390/ph18091245
2. Recent advances in gold nanoparticle-based targeted photodynamic and photothermal cancer therapy.
   Obalola AA, Abrahamse H, Dhilip Kumar SS. · · 2025 · cited 1× · PMID 41159015 · DOI 10.1039/d5na00767d
3. Concept of 2D van der Waals Nanohybrids for Key Biomedical Applications.
   Rejinold NS, Choy JH. · · 2026 · PMID 42039853 · DOI 10.2147/ijn.s559240
4. Reimagining Brain Drug Delivery: Mechanistic and Translational Advances in Carbon Nanotube Nanomedicine.
   Gupta R, Kumar R, Kumar N, Singh P. · · 2026 · PMID 41873211 · DOI 10.1002/jat.70154