Clinical trial · Interventional
Screen and Treat for Cervical Cancer Prevention
Safety and Efficacy of Two Screen-and-Treat Approaches for the Prevention of Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left University
Summary
Brief summary (as posted)
The study measures the impact of "screen-and-treat" on the prevalence of high-grade cervical intraepithelial neoplasia and cancer (CIN 2+). It is a three-arm, randomized clinical trial comparing two "screen-and-treat" approaches to delayed evaluation as a control. The primary outcome is biopsy-confirmed CIN 2+ at 6 months and significant complications within 6 months of randomization with continued follow-up to detect CIN2+ and other complications up to 36 months post-randomization.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV DNA Testing + Cryosurgery | Procedure | — | UNRESOLVED |
| VIA + Cryosurgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- HPV DNA Testing + Cryosurgery
- description
- Patients will undergo a "Screen and Treat" program utilizing HPV DNA testing of clinician-collected cervical samples, followed by cryosurgery of screen positive women.
- interventionNames
- Procedure: HPV DNA Testing + Cryosurgery
- type
- ACTIVE_COMPARATOR
- label
- VIA + Cryosurgery
- description
- Patients will undergo a "Screen and Treat" program utilizing visual inspection of the cervix with acetic acid (VIA), followed by cryosurgery of screen positive women.
- interventionNames
- Procedure: VIA + Cryosurgery
- type
- NO_INTERVENTION
- label
- Delayed Evaluation and Treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Has a cervix * Never been screened for cervical cancer * Not currently pregnant Exclusion Criteria: * Has previously had a Pap smear * Has previously undergone treatment for cervical squamous intraepithelial lesion (SIL) * Have lesions suspicious for cancer, have large acetowhite lesions extending over 70% of the cervix or into endocervical canal, are unsuitable for cryotherapy because of severe atrophy, polyps, cervix distorted, cervix cannot be adequately visualized * Is unable to cooperate with study procedures or tolerate the insertion of a speculum
References
Publications (2)
- RESULTDenny L, Kuhn L, De Souza M, Pollack AE, Dupree W, Wright TC Jr. Screen-and-treat approaches for cervical cancer prevention in low-resource settings: a randomized controlled trial. JAMA. 2005 Nov 2;294(17):2173-81. doi: 10.1001/jama.294.17.2173. PMID 16264158
- DERIVEDKuhn L, Wang C, Tsai WY, Wright TC, Denny L. Efficacy of human papillomavirus-based screen-and-treat for cervical cancer prevention among HIV-infected women. AIDS. 2010 Oct 23;24(16):2553-61. doi: 10.1097/QAD.0b013e32833e163e. PMID 20706107