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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Xiangwen Dong
- Telefonní číslo: +86 15515997079
- E-mail: dongxiangwen1234@163.com
Studijní místa
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Henan
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Zhengzhou, Henan, Čína
- The First Affiliated Hospital of Zhengzhou University
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Kontakt:
- Tengfei Zhang
- Telefonní číslo: 15093333574
- E-mail: fcczhangtf@zzu.edu.cn
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
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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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Diagnostic accuracy of the CRISPR/Cas12a-gold nanoparticle ctDNA test compared with NGS
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Stability of the portable detection device across multiple centers
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2026-KY-0225-003
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