Trial Radar KI | ||
|---|---|---|
Die klinische Studie NCT05282095 für Zervikale Intraepitheliale Neoplasie, HPV-Infektion, Virusintegration, HSIL, hochgradige squamöse intraepitheliale Läsionen ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Effect of HPV Integration on Prognosis of Young Women With CIN2 in China 300
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT05282095 ist eine beobachtungsstudie zur Untersuchung von Zervikale Intraepitheliale Neoplasie, HPV-Infektion, Virusintegration, HSIL, hochgradige squamöse intraepitheliale Läsionen und hat den Status offene rekrutierung. Die Studie startete am 1. Juni 2022 und soll 300 Teilnehmer aufnehmen. Durchgeführt von Fujian Maternity and Child Health Hospital ist der Abschluss für 31. Mai 2026 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 19. September 2024 aktualisiert.
Kurzbeschreibung
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, Tongji Hospital affiliated to Tongji...Mehr anzeigen
Ausführliche Beschreibung
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 300 participant...Mehr anzeigen
Offizieller Titel
Effect of HPV Integration on Prognosis of Young Women With CIN2 in China: A Multi-center Cohort Study in China
Erkrankungen
Zervikale Intraepitheliale NeoplasieHPV-InfektionVirusintegrationHSIL, hochgradige squamöse intraepitheliale LäsionenPublikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:Weitere Studien-IDs
- HPVZHCIN22021
NCT-Nummer
Studienbeginn (tatsächlich)
2022-06-01
Zuletzt aktualisiert
2024-09-19
Studienende (vorauss.)
2026-05-31
Geplante Rekrutierung
300
Studientyp
Beobachtungsstudie
Status
Offene Rekrutierung
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
Women aged from 18-45 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 four, at 3th month, 6th month, 9th month and 12th month. | Nachverfolgung Participants will be followed up at baseline, 3th, 6th, 9th and 12th months with HPV viral integration tests, HPV genotyping tests, thinprep cytologic tests (TCT) for cervix and vaginal secretion tests. Colposcopies and biopsies will be performed on the participants at 6 - and 12-month follow-up. |
Hauptergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Cervical histopathology testing at baseline | Cervical histopathology was performed at baseline for all participants. | Baseline |
Cervical histopathology testing at 6-month follow-up | Cervical histopathology was performed at 6-month follow-up for all participants. | 6-month follow-up |
Cervical histopathology testing at 12-month follow-up | Cervical histopathology was performed at 12-month follow-up for all participants. | 12-month follow-up |
Human Papillomavirus (HPV) viral integration test at baseline | Human Papillomavirus (HPV) viral integration test was performed at baseline for all participants. | Baseline |
Human Papillomavirus (HPV) viral integration test at 6-month follow-up | Human Papillomavirus (HPV) viral integration test was performed at 6-month follow-up for all participants. | 6-month follow-up |
Human Papillomavirus (HPV) viral integration test at 12-month follow-up | Human Papillomavirus (HPV) viral integration test was performed at 12-month follow-up for all participants. | 12-month follow-up |
Cervical cytology testing at baseline | All participants were tested for cervical cytology at the time of baseline. | Baseline |
Cervical cytology testing at 3-month follow-up | All participants were tested for cervical cytology at 3-month follow-up. | 3-month follow-up |
Cervical cytology testing at 6-month follow-up | All participants were tested for cervical cytology at 6-month follow-up | 6-month follow-up |
Cervical cytology testing at 9-month follow-up | All participants were tested for cervical cytology at 9-month follow-up | 9-month follow-up |
Cervical cytology testing at 12-month follow-up | All participants were tested for cervical cytology at 12-month follow-up | 12-month follow-up |
16SrRNA sequencing of the vaginal secretions at baseline | All participants underwent vaginal secretion sequencing at baseline. | Baseline |
16SrRNA sequencing of the vaginal secretions at 3-month follow-up | All participants underwent vaginal secretion sequencing at 3-month follow-up. | 3-month follow-up |
16SrRNA sequencing of the vaginal secretions at 6-month follow-up | All participants underwent vaginal secretion sequencing at 6-month follow-up | 6-month follow-up |
16SrRNA sequencing of the vaginal secretions at 9-month follow-up | All participants underwent vaginal secretion sequencing at 9-month follow-up | 9-month follow-up |
16SrRNA sequencing of the vaginal secretions at 12-month follow-up | All participants underwent vaginal secretion sequencing at 12-month follow-up | 12-month follow-up |
Human Papillomavirus (HPV) genotyping tests at baseline | All participants underwent Human Papillomavirus (HPV) genotyping tests at baseline. | Baseline |
Human Papillomavirus (HPV) genotyping tests at 3-month follow-up | All participants underwent Human Papillomavirus (HPV) genotyping tests at 3-month follow-up. | 3-month follow-up |
Human Papillomavirus (HPV) genotyping tests at 9-month follow-up | All participants underwent Human Papillomavirus (HPV) genotyping tests at 9-month follow-up. | 9-month follow-up |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind, Erwachsene
Zugelassene Geschlechter
Weiblich
- Female, 18 years of age or older and 45 years of age or younger, with a desire to conceive;
- Diagnosed with HSIL (CIN2) or HSIL (CIN2-3) via cervical tissue biopsy within the past 3 months, and has not undergone cervical surgery, physical, or medication treatment;
- The lesion area under colposcopy is less than 50% of the total cervical area within the past 3 months;
- Plans for 12-month follow-up observation for CIN2, with no surgical, physical, or medication treatment if the disease does not progress;
- Understands and voluntarily agrees to participate in the 12-month follow-up of this study, and signs the informed consent form.
- Cervical status at the time of enrollment as determined by colposcopy within the past three months is Type III transformation zone;
- Pregnant or lactating;
- History of malignant reproductive tract tumors;
- History of hysterectomy, cervical surgery, or pelvic radiation therapy;
- Physical therapy to the cervix within 24 months prior to enrollment;
- The subject has a severe immune system disease that is active;
- Long-term use of contraceptives within 12 months prior to enrollment;
- Vaginal medication or irrigation within 72 hours prior to sampling (can re-enroll for sampling 3 days after cessation);
- Sexual intercourse within 24 hours prior to sampling (can re-enroll for sampling 24 hours after cessation);
- Received treatment for genital tract infections, HPV, or other STD pathogens within the past month (can re-enroll one month after cessation of treatment);
- Used antibiotics or vaginal microecological improvement products within the past month (can re-enroll one month after cessation of use);
Fujian Maternity and Child Health HospitalVerantwortliche Partei
Binhua Dong, Hauptprüfer, Principal Investigator, Fujian Maternity and Child Health Hospital
Zentrale Studienkontakte
Kontakt: Binhua Dong, +86-591-87558732, [email protected]
Kontakt: Pengming Sun, +86-591-87558732, [email protected]
20 Studienstandorte in 1 Ländern
Fujian
Fujian Maternity and Child Health Hospital, Fuzhou, Fujian, 350001, China
Binhua Dong, Kontakt, +8613599071900, [email protected]
Offene Rekrutierung
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Peifang Chen, Kontakt
Offene Rekrutierung
The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China
Lihong Chen, Kontakt
Offene Rekrutierung
Longyan First Hospital, Longyan, Fujian, China
Jinyong Wang, Kontakt
Offene Rekrutierung
The Second Hospital of Longyan, Longyan, Fujian, China
Wenrong Huang, Kontakt
Offene Rekrutierung
Ningde Municipal Hospital of Ningde Normal University, Ningde, Fujian, 352100, China
Wenfang Jin, Kontakt, +8618559336833
Offene Rekrutierung
The First Hospital of Putian City, Putian, Fujian, 351100, China
Xianqian Chen, Kontakt, +8618559336833
Offene Rekrutierung
The Affiliated Hospital of Putian University, Putian, Fujian, China
Lijun Li, Kontakt
Offene Rekrutierung
Sanming Second Hospital, Sanming, Fujian, China
Yisheng Lin, Kontakt
Offene Rekrutierung
Zhangzhou affiliated Hospital of Fujian Medical University, Zhangzhou, Fujian, 363000, China
Feifeng Shi, M.D, Kontakt, +8613960086066
Offene Rekrutierung
Gansu
Gansu Provincial Maternal and Child Health Care Hospital, Lanzhou, Gansu, China
Xunyuan Tuo, Kontakt
Offene Rekrutierung
Guangdong
Shenzhen Maternity and Child HealthCare Hospital, Shenzhen, Guangdong, China
Zheng Zheng, Kontakt
Offene Rekrutierung
Guizhou
Guiyang maternal and child health care hospital, Guiyang, Guizhou, China
Juntao Wang, Kontakt
Offene Rekrutierung
Hubei
Hubei Maternal and Child Health Care Hospital, Wuhan, Hubei, China
Hongning Cai, Kontakt
Offene Rekrutierung
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan, Hubei, China
Yan Li, Kontakt
Offene Rekrutierung
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
Wei Zhang, Kontakt
Offene Rekrutierung
Jiangxi
Jiangxi maternal and Child Health Hospital, Nanchang, Jiangxi, China
Ling Li, Kontakt
Offene Rekrutierung
Shanghai Municipality
Shanghai First Maternity and Infant Hospital, Shanghai, Shanghai Municipality, China
Xiaowen Pu, Kontakt
Offene Rekrutierung
Shanxi
Northwest Women's and Children's Hospital, Xi’an, Shanxi, China
Hongwei Tan, Kontakt
Offene Rekrutierung
Zhejiang
The First Affiliated Hospital of Ningbo University, Ningbo, Zhejiang, China
Yutao Guan, Kontakt
Offene Rekrutierung