Effect of HPV Integration on Prognosis of Young Women With CIN2 in China

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeUp to 45
SponsorFujian Maternity and Child Health Hospital

About this trial

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 Medical College of Huazhong University of Science \& Technology and other hospitals, including 300 CIN2 participants aged 45 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial population

≤45 years old Chinese women with cervical histopathology for CIN2.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Follow up

    Other intervention

    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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Women aged from 18-45 with histopathologically confirmed CIN21 intervention

Trial outcomes

Primary outcomes

1

Cervical histopathology testing at baseline

Cervical histopathology was performed at baseline for all participants.

Time frame
Baseline
2

Cervical histopathology testing at 6-month follow-up

Cervical histopathology was performed at 6-month follow-up for all participants.

Time frame
6-month follow-up
3

Cervical histopathology testing at 12-month follow-up

Cervical histopathology was performed at 12-month follow-up for all participants.

Time frame
12-month follow-up
4

Human Papillomavirus (HPV) viral integration test at baseline

Human Papillomavirus (HPV) viral integration test was performed at baseline for all participants.

Time frame
Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

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