Testing new device for detecting cancer of cervix a part of female genital tract
- Conditions
- Health Condition 1: N72- Inflammatory disease of cervix uteri
- Registration Number
- CTRI/2024/01/061297
- Lead Sponsor
- Datta Meghe Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Between 25 and 65 years age
2.Irrespective of marital status, with a history of sexual cohabitation,
3.Complaints of vaginal and blood mixed discharge, foul-smell in discharge, postcoital bleeding, postmenopausal bleeding, Intermenstrual bleeding, lower abdominal pain
4.showing lesion on cervix after visual inspection with acetic acid application and
5.Abnormal Pap smear report: Atypical squamous cells of undetermined significance (ASCUS), atypical squamous cells, cannot exclude HSIL (ASC-H), low-grade intraepithelial lesion (LSIL), high-grade intraepithelial, lesion (HSIL) and cancerous (Ca) on Pap test WAS considered as positive.
1. Lactating and pregnant women
2 Active vaginal bleeding
3. Frank growth on cervix
4. Post-hysterectomy patients
5. Those who are not sexually active
6. Women who have undergone prior treatment for cervical intraepithelial neoplasia (CIN) and cervical cancer.
•Women below 25 years old and above the age of 65 years
•Individuals with previous history of any systemic malignancies or any other major systemic terminal disease
•Individuals who will refuse to participate or give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method primary outcome will measure the level of agreement and ? (kappa) statistic between both devices. The agreement on colposcopy findings between the two methods will be determined using Cohen’s Kappa coefficient.Timepoint: at 4 weeks
- Secondary Outcome Measures
Name Time Method our secondary outcome measure will be level of agreement between 2 devices in terms of its performanceTimepoint: at baseline