Detection Technology of Peripheral Blood ctDNA Based on CRISPR/Cas and Gold Nanoparticles
This study tests a new, fast blood test that may help detect very small traces of tumor DNA in the bloodstream. When tumor cells die, they release small pieces of DNA called circulating tumor DNA (ctDNA) into the blood. Finding these pieces can help doctors diagnose cancer, monitor how well treatment is working, and detect cancer recurrence earlier. However, ctDNA is present in very small amounts and is hard to detect with current methods. Newer techniques such as next-generation sequencing (NGS) can find ctDNA, but they are expensive, require specialized laboratories, and take days to return results. This study evaluates a new testing method called "CRISPR/Cas12a combined with gold nanoparticle detection." This method uses a gene-editing protein (Cas12a) that can recognize a specific mutation in the BRCA1 gene and a gold nanoparticle-based readout that shows results within about 30 minutes, using portable equipment.
The main purpose of this study is to find out how accurate, sensitive, and specific this new test is compared with NGS, which is considered the gold standard. The study will also check whether the portable device works consistently across different hospitals and whether the test results match patients' responses to treatment.
The study will enroll adult cancer patients treated at participating hospitals and a group of healthy volunteers. All participants will provide about 3 mL of blood (less than one teaspoon). No additional invasive procedures or extra hospital visits are required beyond routine blood draws. For cancer patients, part of the blood sample will be tested with the new method and part will be tested with standard NGS, and the two results will be compared. Healthy volunteers' blood will be used to confirm that the test does not produce false positive results.
There is no direct physical harm from the test itself, since it is performed on blood samples in the laboratory. Participants will receive the ctDNA test free of charge, and their test results may help their doctors better understand their disease.
The results of this study may help develop a rapid, low-cost, bedside test for tumor DNA, which could improve cancer diagnosis and monitoring in the future.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Xiangwen Dong
- Phone Number: +86 15515997079
- Email: dongxiangwen1234@163.com
Study Locations
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Henan
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Zhengzhou, Henan, China
- The First Affiliated Hospital of Zhengzhou University
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Contact:
- Tengfei Zhang
- Phone Number: 15093333574
- Email: fcczhangtf@zzu.edu.cn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The study population consists of two groups: (1) Cancer patients - adult patients with BRCA1-related tumors (e.g., breast, ovarian, or prostate cancer) receiving care at The First Affiliated Hospital of Zhengzhou University (lead site) and Sir Run Run Shaw Hospital, Zhejiang University (participating site), who agree to provide a peripheral blood sample; and (2) Healthy volunteers - adults without a history of cancer, recruited at the participating hospitals as the control group for specificity assessment. All participants provide written informed consent before enrollment. Participants are recruited based on the principles of voluntariness and fairness, without discrimination by race, gender, or socioeconomic status
Description
Inclusion Criteria:
- Adults (≥18 years of age) diagnosed with a malignant tumor at one of the participating hospitals
- Patients willing and able to provide written informed consent
Exclusion Criteria:
- Patients who refuse or are unable to sign the informed consent form
- Patients with severe hematologic or coagulation disorders that make blood collection infeasible
- Healthy volunteers: adults (≥18 years) with no history of cancer, willing to provide written informed consent
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: PROSPECTIVE
Cohorts and Interventions
Group / Cohort |
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Cancer patients
Patients with BRCA1-related tumors (e.g., breast, ovarian, or prostate cancer) enrolled at participating hospitals. Approximately 3 mL of EDTA-anticoagulated peripheral blood is collected from each participant. Each sample is tested by both the investigational CRISPR/Cas12a-gold nanoparticle ctDNA detection method and next-generation sequencing (NGS, the gold standard reference), and the results of the two methods are compared to evaluate diagnostic accuracy and sensitivity. |
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Healthy Volunteers
Healthy adults without a history of cancer, enrolled as the control group for specificity assessment. Approximately 3 mL of EDTA-anticoagulated peripheral blood is collected from each participant and tested by the CRISPR/Cas12a-gold nanoparticle method to determine the false positive rate. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Diagnostic accuracy of the CRISPR/Cas12a-gold nanoparticle ctDNA test compared with NGS
Time Frame: through study completion, an average of 1 year
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The agreement between the CRISPR/Cas12a-gold nanoparticle ctDNA detection method and next-generation sequencing (NGS, the gold standard reference) will be evaluated in tumor patient samples. Diagnostic accuracy is measured by the Kappa coefficient of concordance between the two methods, with Kappa ≥0.85 considered excellent agreement. Sensitivity (detection positive rate of 1 pM, 0.5 pM, and 0.1 pM target ctDNA samples; ≥95% considered qualified) and specificity (false positive rate in 50 healthy volunteer samples; ≤5% considered qualified) will also be assessed. |
through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Stability of the portable detection device across multiple centers
Time Frame: through study completion, an average of 1 year
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Inter-site consistency of the portable device will be assessed by the coefficient of variation (CV) of the same batch of standard samples tested at multiple centers; CV ≤10% is considered qualified. |
through study completion, an average of 1 year
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-KY-0225-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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