Clinical trial · Observational
New Strategies to Assess Anal Cancer Risk In Women
- 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 purpose of this research is to study different strategies to identify women at highest risk for anal cancer. Primarily, investigators want to study a risk assessment called the Anal Cancer Risk Index; it gives women an overall number score based on risk factors that they may have for anal cancer, such as age, number of sexual partners, or smoking. Investigators seek to understand whether women with higher Anal Cancer Risk Index scores are more likely to have abnormal results on anal pap smears, HPV tests, or anal biopsies. The study team will collect swabs of the cervix and the anus to study different laboratory tests that could identify women at highest risk of cervical and anal cancer. These laboratory tests include an anal pap smear, tests for markers of disease and tests that detect the HPV types most likely to cause cancer. The study team would like to see which of these laboratory tests do the best job at predicting precancerous lesions in the anus and are better indicators of risk for cancer. After collecting these swabs, women will have a procedure called high resolution anoscopy where investigators look closely at the anus and biopsy any suspicious areas. Finally, the study team will look for HPV proteins and changes that HPV can make in cells to see if these tests predict anal lesions.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Immunodeficiency Virus (HIV) | — | UNRESOLVED | — |
| Human Papillomavirus (HPV) | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anal Swabs | Procedure | — | UNRESOLVED |
| Cervical Swabs | Procedure | — | UNRESOLVED |
| High Resolution Anoscopy (HRA) | Procedure | — | UNRESOLVED |
| Perianal and Digital Anorectal Exam | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Validation Study
- description
- Participants will undergo a perianal and digital anorectal exam, a high resolution anoscopy, and cervical and anal swabs to determine the best method to identify women at high risk for anal cancer.
- interventionNames
- Procedure: Perianal and Digital Anorectal Exam
- Procedure: Cervical Swabs
- Procedure: Anal Swabs
- Procedure: High Resolution Anoscopy (HRA)
Primary outcomes (2)
- measure
- Anal Cancer Risk Index Score
- timeFrame
- Day 1
- description
- Assessment of anal cancer screening, risk factors for anal cancer, and its association with HPV using AIDS Risk Reduction Model Framework, that is a three stage model, including knowledge as a prerequisite to recognize risk and to take action to change or reduce the risk. Knowledge was measured with the Knowledge of Anal cancer and HPV, that is a 44-item knowledge multiple choice survey adapted from the Hild-Mosely, et al study, substituting "cervical" with "anal". A percentage score of correct responses was calculated and range from o to 100, being 100 the maximum correct result.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Currently enrolled in the Women's HIV Interagency Study (WIHS) study * Able and willing to undergo anal cytology, anal molecular testing, and high resolution anoscopy with targeted anal biopsies Exclusion Criteria: * History of high grade anal intraepithelial neoplasia (AIN 2 or 3) * History of active anal disease requiring surgery * History of anal or cervical cancer
References
Publications (2)
- BACKGROUNDWells JS, Flowers L, Paul S, Nguyen ML, Sharma A, Holstad M. Knowledge of Anal Cancer, Anal Cancer Screening, and HPV in HIV-Positive and High-Risk HIV-Negative Women. J Cancer Educ. 2020 Jun;35(3):606-615. doi: 10.1007/s13187-019-01503-8. PMID 30850945
- BACKGROUNDLahiri CD, Nguyen ML, Mehta CC, Mosunjac M, Tadros T, Unger ER, Rajeevan MS, Richards J, Ofotokun I, Flowers L. Pilot Study of Markers for High-grade Anal Dysplasia in a Southern Cohort From the Women's Interagency Human Immunodeficiency Virus Study. Clin Infect Dis. 2020 Mar 3;70(6):1121-1128. doi: 10.1093/cid/ciz336. PMID 31058984