Clinical trial · Interventional
Post Colposcopy Management of ASC-US and LSIL Pap Tests
Post Colposcopy Management of ASC-US and LSIL Pap Tests (PALS Trial): Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
There is weak evidence supporting optimal follow-up of women with ASC-US or LSIL cytology found to have low grade disease or normal findings at initial colposcopy. Surveillance options include continued colposcopy, discharge with Pap testing, or HPV testing at 12 months. The investigators performed a pilot randomized controlled trial (RCT) comparing these 3 follow-up policies. Study objectives are to determine the feasibility of an RCT and to compare the incidence of \>/=HSIL in each of the arms by intention to treat principle.
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 Screening | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colposcopy | Procedure | — | UNRESOLVED |
| HPV test | Diagnostic Test | — | UNRESOLVED |
| Pap test | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Colposcopy arm
- description
- Patients received colposcopy as per standard of care
- interventionNames
- Procedure: Colposcopy
- type
- EXPERIMENTAL
- label
- Pap arm
- description
- Patients received a Pap test only
- interventionNames
- Other: Pap test
- type
- EXPERIMENTAL
- label
- HPV arm
- description
- Patients received an HPV test only
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * One previous routine screening Pap test showing ASC-US, HPV positive * Two previous consecutive routine screening Pap tests showing ASC-US or LSIL Exclusion Criteria: * previous hysterectomy * pregnant or considering pregnancy in the next 18 months * had a previous excisional or ablative procedure of the cervix * younger than 18.
References
Publications (0)
Data not yet available