Clinical trial · Interventional
The Self-Sampling Pilot Study
Self-Sampling to Optimize Anal Lesion Outcomes (SOLO) Pilot
- 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)
The investigators will test the cytological performance of a nylon-flocked swab at two insertion depths in the anus, 3 cm and 5 cm, to determine which insertion depth is better at collecting cells from the squamocolumnar junction (SCJ), an anatomic site that is particularly vulnerable to carcinogenic transformation. The investigators hypothesize that the 5 cm insertion will result in a higher quality specimen with cells from the SCJ. However, the deeper swab insertion may affect end user acceptability without increasing adequacy or quality.
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 |
|---|---|---|---|
| Squamous Cell Carcinoma of the Anus | Anal Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inserting a swab 5 cm into the anus during self-sampling | Other | — | UNRESOLVED |
| Self-sampling with a swab by inserting the swab 3 cm into the anus. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention arm
- description
- Individuals in the intervention arm will self-sample with a swab and insert the swab 5 cm into the anus.
- interventionNames
- Other: Inserting a swab 5 cm into the anus during self-sampling
- type
- ACTIVE_COMPARATOR
- label
- Control arm
- description
- Individuals in the control arm will self-sample with a swab and insert the swab 3 cm into the anus.
- interventionNames
- Other: Self-sampling with a swab by inserting the swab 3 cm into the anus.
Primary outcomes (1)
- measure
- Presence of Squamocolumnar Cells
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged ≥ 35 years. 2. Must be either: 1. A sexual minority man, or 2. A woman who has a different identity than the sex she was born with. 3. Resides in the Milwaukee metropolitan area. 4. Speak and understand English. 5. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: 1\. Presence of any contraindicating severe anal disease or condition, e.g., anal stenosis.
References
Publications (0)
Data not yet available