Effect of HPV Integration on Prognosis of Young Women With CIN2 in China
Study Details
Study Description
Brief Summary
Clinically, cervical precancerous lesion is one of the important diseases that endanger the life safety and fertility of young women. Women with histopathologically confirmed CIN2 need regular HPV, cervical cytology, and colposcopic biopsy if necessary to assess the outcome and progression of the disease. In this study, we intend to visit Fujian Maternal and Child Health Hospital, Ningde Mindong Hospital, Zhangzhou Hospital and other hospitals, including 500 CIN2 participants aged 35 and below diagnosed by histopathology, and collect the remaining cervical secretions and cervical exfoliated cell samples after clinical examination, even if you do not participate in this clinical study. In clinical diagnosis, treatment and follow-up, it is also necessary to collect the above specimens for relevant medical tests. Therefore, it is of great clinical and scientific significance to explore the role of HPV integrated detection in predicting the prognosis of young women with CIN2.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This study aims to:1) determine the correlation between HPV integration and natural outcome in young CIN2 women. 2) determine the prognostic value of different HPV integration status in young women with CIN2. 3) determine the relationship between the integration status of different HPV genes in young CIN2 women and the results of vaginal flora and cervical exfoliative cytology. A prospective cohort of 500 participants under 35 years of age with histopathologically confirmed CIN2 was recruited from multiple centers, and HPV integration status, HPV infection status, cervical cytology, and vaginal flora diversity sequencing were performed at enrollment, 6 months, and 12 months. The purpose of this study was to evaluate the effect of HPV integration status and flora changes on the outcome and progression of HR-HPV persistent infection in women, and to evaluate the correlation between HPV integration status and cervical cytology results.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Women aged from 18-35 with histopathologically confirmed CIN2 In the enrollment, women whose cervical histopathological results have been diagnosed as cervical intraepithelial neoplasia (CIN2) for the last 3 months with abnormal results will be included in this study. All participants will be followed up twice, at 6th month and 12th month. |
Other: Follow up
Participants will be followed up at baseline, 6th and 12th months with HPV viral integration tests, HPV genotyping tests, thinprep cytologic tests (TCT) for cervix and vaginal secretion tests. Colposcopy and biopsy will be conducted for participants if necessary.
|
Outcome Measures
Primary Outcome Measures
- Cervical histopathology testing at baseline [Baseline]
Cervical histopathology was performed at baseline for all participants.
- Cervical histopathology testing at 6-month follow-up [6-month follow-up]
Cervical histopathology was performed at 6-month follow-up for all participants.
- Cervical histopathology testing at 12-month follow-up [12-month follow-up]
Cervical histopathology was performed at 12-month follow-up for all participants.
- Human Papillomavirus (HPV) viral integration test at baseline [Baseline]
Human Papillomavirus (HPV) viral integration test was performed at baseline for all participants.
- Human Papillomavirus (HPV) viral integration test at 6-month follow-up [6-month follow-up]
Human Papillomavirus (HPV) viral integration test was performed at 6-month follow-up for all participants.
- Human Papillomavirus (HPV) viral integration test at 12-month follow-up [12-month follow-up]
Human Papillomavirus (HPV) viral integration test was performed at 12-month follow-up for all participants.
- Cervical cytology testing at baseline [Baseline]
All participants were tested for cervical cytology at the time of baseline.
- Cervical cytology testing at 6-month follow-up [6-month follow-up]
All participants were tested for cervical cytology at 6-month follow-up
- Cervical cytology testing at 12-month follow-up [12-month follow-up]
All participants were tested for cervical cytology at 12-month follow-up
- 16SrRNA sequencing of the vaginal secretions at baseline [Baseline]
All participants underwent vaginal secretion sequencing at baseline.
- 16SrRNA sequencing of the vaginal secretions at 6-month follow-up [6-month follow-up]
All participants underwent vaginal secretion sequencing at 6-month follow-up
- 16SrRNA sequencing of the vaginal secretions at 12-month follow-up [12-month follow-up]
All participants underwent vaginal secretion sequencing at 12-month follow-up
- Human Papillomavirus (HPV) genotyping tests at baseline [Baseline]
All participants underwent Human Papillomavirus (HPV) genotyping tests at baseline.
- Human Papillomavirus (HPV) genotyping tests at 12-month follow-up [12-month follow-up]
All participants underwent Human Papillomavirus (HPV) genotyping tests at 12-month follow-up.
- Human Papillomavirus (HPV) genotyping tests at 6-month follow-up [6-month follow-up]
All participants underwent Human Papillomavirus (HPV) genotyping tests at 6-month follow-up.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women aged from 18-35 with sexual history
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Young woman with histopathologically confirmed CIN2
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No history of cervical conization or total hysterectomy, etc.
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No sexual experience, vaginal medication or drug flushing within 72 hours before sampling
Exclusion Criteria:
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Within 8 weeks after pregnancy or postpartum.
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Patients with history of genital tract tumor.
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History of HPV vaccination.
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Previous history of hysterectomy, cervical surgery, pelvic radiotherapy Historical.
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In recent one month, she has received genital tract infection, HPV or other STDs treatment related to the infection of mycoplasma.
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Use antibiotics or vaginal microecological improvement products in recent 1 month.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fujian Maternity and Child Health Hospital | Fuzhou | Fujian | China | 350001 |
| 2 | Mindong Hospital of Ningde City | Ningde | Fujian | China | 352000 |
| 3 | Ningde Municipal Hospital of Ningde Normal University | Ningde | Fujian | China | 352100 |
| 4 | The First Hospital of Putian City | Putian | Fujian | China | 351100 |
| 5 | Quanzhou First Hospital Afflicated to Fujian Medical University | Quanzhou | Fujian | China | 362000 |
| 6 | Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University | Xiamen | Fujian | China | 361000 |
| 7 | Zhangzhou affiliated Hospital of Fujian Medical University | Zhangzhou | Fujian | China | 363000 |
| 8 | The First Hospital of Fuzhou City | Fuzhou | China | ||
| 9 | Longyan First Hospital | Longyan | China | ||
| 10 | Nanping Second Hospital | Nanjing | China | ||
| 11 | Sanming Second Hospital | Sanming | China |
Sponsors and Collaborators
- Fujian Maternity and Child Health Hospital
Investigators
- Study Chair: Pengming Sun, Fujian Maternal and Child Health Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HPVZHCIN22021