Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06644677
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Third-Generation Nanopore HPV Integration Site for Precise Prediction of Cervical Cancer Prognosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development of a Third-Generation Nanopore HPV Integration Site Detection Kit for Precise Prediction of Cervical Cancer Prognosis
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cervical cancer is a significant health threat to women with over 500000 new cases and approximately 342000 deaths worldwide annually and about 107000 new cases in China with 51000 fatalities Current screening methods include HPV testing cytology colposcopy and biopsy but none can detect HPV genome integration in persistently positive patients
Our team has analyzed over 200 cervical cell samples using third-generation nanopore technology focusing on HPV integration sites Weve developed a proprietary long-fragment capture and sequencing method reads averaging 2-5kb that identifies precise HPV insertion points and detects the complete Human-Virus-Human H-V-H viral insertion sequence We found overlaps in HPV integration genes across different stages of cervical intraepithelial neoplasia CIN and in cancer patients with recurrence and metastasis suggesting potential biomarkers for tumor progression and poor prognosis
We also analyzed HPV sequence proportions and gene insertion numbers in samples from patients before and after radical radiochemotherapy providing insights into treatment efficacy and prognosis Our study aims to use a domestic nanopore sequencing platform and probes tailored to Chinese HPV infection patterns to detect integration sites in late-stage cervical cancer and post-treatment recurrencemetastasis patients We aim to optimize our method to complete the entire detection process within eight hours expanding the technologys application in point-of-care diagnostics and decentralization
Our team has analyzed over 200 cervical cell samples using third-generation nanopore technology focusing on HPV integration sites Weve developed a proprietary long-fragment capture and sequencing method reads averaging 2-5kb that identifies precise HPV insertion points and detects the complete Human-Virus-Human H-V-H viral insertion sequence We found overlaps in HPV integration genes across different stages of cervical intraepithelial neoplasia CIN and in cancer patients with recurrence and metastasis suggesting potential biomarkers for tumor progression and poor prognosis
We also analyzed HPV sequence proportions and gene insertion numbers in samples from patients before and after radical radiochemotherapy providing insights into treatment efficacy and prognosis Our study aims to use a domestic nanopore sequencing platform and probes tailored to Chinese HPV infection patterns to detect integration sites in late-stage cervical cancer and post-treatment recurrencemetastasis patients We aim to optimize our method to complete the entire detection process within eight hours expanding the technologys application in point-of-care diagnostics and decentralization
Detailed Description:
Cervical cancer is the most common malignant tumor of the reproductive tract posing a serious threat to womens health According to data from the World Health Organization WHO there are over 500000 new cases of cervical cancer globally each year with approximately 342000 deaths In China there are about 107000 new cases annually with around 51000 patients dying from cervical cancer The market for detection is vast and continues to grow The main methods of examination after cervical cancer screening and treatment include HPV testing cytological screening colposcopy and cervical biopsy All HPV tests on the market are qualitative and semi-quantitative and there is currently no product on the market that can detect whether HPV integrates into the genome in patients with persistent HPV positivity
Our team in previous research enrolled over 200 cervical cell samples including those from patients with high-risk HPV infection without intraepithelial neoplasia cervical intraepithelial neoplasia CIN I CIN II CIN III and samples from locally advanced cervical cancer before and after radiochemotherapy at multiple time points Using third-generation nanopore technology we have completed experiments and analysis on 93 cervical cell samples Based on the probe hybridization capture principle we enriched and sequenced the integration sites of HPV viral DNA Preliminary conclusions are as follows
1 Through our self-developed experimental technology process we achieved long-fragment virus capture and sequencing average read length 2-5kb identifying HPV insertion sites and more precise genomic localization Moreover nanopore long-fragment sequencing can detect the complete Human-Virus-Human H-V-H viral insertion structure sequence
2 There is a certain proportion of overlap between the HPV insertion genes in the inflammation group CIN I CIN II CIN III groups and the HPV insertion genes in cancer patients with recurrence and metastasis which can further assist in screening for molecular markers related to tumor progression and poor prognosis
3 The proportion of HPV sequences and the number of inserted genes in patient samples before and after radical radiochemotherapy can further assess the effectiveness of treatment and prognosis providing support data for pre-treatment intervention and risk warning
The goal of this study is to collaborate with a domestically produced nanopore sequencing platform and self-designed probes targeting the characteristics of HPV infection in the Chinese population We aim to conduct insertion site detection on cohorts of late-stage cervical cancer stage IIIB and beyond and patients with recurrence and metastasis after radical cervical cancer radiochemotherapy We will further establish and optimize the long-fragment virus enrichment method and nanopore sequencing experimental process to complete the entire detection process within one working day 8 hours This will also expand the application of the technology in bedside diagnosis and decentralized directions
Our team in previous research enrolled over 200 cervical cell samples including those from patients with high-risk HPV infection without intraepithelial neoplasia cervical intraepithelial neoplasia CIN I CIN II CIN III and samples from locally advanced cervical cancer before and after radiochemotherapy at multiple time points Using third-generation nanopore technology we have completed experiments and analysis on 93 cervical cell samples Based on the probe hybridization capture principle we enriched and sequenced the integration sites of HPV viral DNA Preliminary conclusions are as follows
1 Through our self-developed experimental technology process we achieved long-fragment virus capture and sequencing average read length 2-5kb identifying HPV insertion sites and more precise genomic localization Moreover nanopore long-fragment sequencing can detect the complete Human-Virus-Human H-V-H viral insertion structure sequence
2 There is a certain proportion of overlap between the HPV insertion genes in the inflammation group CIN I CIN II CIN III groups and the HPV insertion genes in cancer patients with recurrence and metastasis which can further assist in screening for molecular markers related to tumor progression and poor prognosis
3 The proportion of HPV sequences and the number of inserted genes in patient samples before and after radical radiochemotherapy can further assess the effectiveness of treatment and prognosis providing support data for pre-treatment intervention and risk warning
The goal of this study is to collaborate with a domestically produced nanopore sequencing platform and self-designed probes targeting the characteristics of HPV infection in the Chinese population We aim to conduct insertion site detection on cohorts of late-stage cervical cancer stage IIIB and beyond and patients with recurrence and metastasis after radical cervical cancer radiochemotherapy We will further establish and optimize the long-fragment virus enrichment method and nanopore sequencing experimental process to complete the entire detection process within one working day 8 hours This will also expand the application of the technology in bedside diagnosis and decentralized directions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None