NCI Cervical Cancer 'Last Mile' Initiative 'Self-collection for HPV Testing to Improve Cervical Cancer Prevention
- Conditions
- HPV (Human Papillomavirus)-Associated
- Registration Number
- NCT06676150
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
To look at the results from a sample collected for human papillomavirus (HPV) testing similar or the same as the results from the cervical sample collected by a doctor.
- Detailed Description
Primary Objectives:
To evaulate clinical accuracy (including clinical sensitivity, clinical specificity, false positive rate, and false negative rate) for detection of cervical precancer/cancer and agreement/concordance (including positive percent agreement and negative percent agreement) on SC versus CC Samples for the following HPV genotype detections and groupings:
* Any HR HPV genotype
* HPV16
* Other individual HR HPV and/or assay-specific channels/pooled genotypes
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 500
- Willingness and ability to provide a documented informed consent.
- Is 25 years of older.
- Has an intact cervix.
- Has had a referral for colposcpoy and/or cervical excisional procedure in which routine cervical cancer screening has included HPV testing (HPV primary screeing, co-testing, or ASC-US cytology triage) or abnormal cytology performed within the past 12 months preceding the referral visit.
- Willing and able to undergo colposcopy, and if clinically indicated for SOC purposes, a biopsy, endocervical curettage, and/or cervical excisional procedure, as applicable.
Exclusion Criteria
An individiual meeting the following criteria will be ineligible for participation in the study:
- Is pregnant when presenting for the referal visit or gave birth within the past three months.
- Has known history of excisional or ablative therapy to the cervix (e.g., LEEP, cone biopsy, cervical laser surgery, cryotherpay, thermal ablation) in the last 12 months prior to the referral visit.
- Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records.
- Known medical conditions that, in the opinion of the investigator, prelude study participation.
- Previous participation in the SHIP Trial. Participation is defined as completing the self-collection.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival Through study completion; an average of 1 year. Progression Free Survival
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States