NCT07034248

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

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
51mo left

Started Jul 2025

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Jul 2025Jul 2030

First Submitted

Initial submission to the registry

June 15, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
26 days until next milestone

Study Start

First participant enrolled

July 20, 2025

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2030

Last Updated

July 18, 2025

Status Verified

March 1, 2025

Enrollment Period

5 years

First QC Date

June 15, 2025

Last Update Submit

July 15, 2025

Conditions

Keywords

Electrochemically sensing probsulfur-doped graphene quantum dotsbreast cancer diagnosis

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

Other: Electrochemical biosensor

experimental

breast cancer participants

Other: Electrochemical biosensor

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

controlexperimental

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • CHIA-HSUN Hsieh, M.D PhD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chia-Hsun Hsieh, PhD

CONTACT

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