Testing a blood test for anal cancer screening
Assessing the Utility of Plasma ctHPVDNA for Anal Cancer Screening
This study is testing a blood test to see if it can help find early signs of anal cancer in people who have HPV and those without any known issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 101 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts Eye and Ear Infirmary Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06971276 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a liquid biopsy assay that detects circulating tumor HPV DNA (ctHPVDNA) in blood samples for screening and classifying anal dysplasia. Given the rising incidence of anal squamous cell carcinoma, the study seeks to improve current screening methods, which rely heavily on HPV testing and high-resolution anoscopy. By utilizing an ultrasensitive HPV whole genome sequencing assay, the researchers hypothesize that anal precancers can be identified through blood tests, potentially offering a non-invasive alternative for early detection. The study includes both HPV-positive individuals who have undergone anal dysplasia screening and control patients from the general population.
Who should consider this trial
Good fit: Ideal candidates include individuals with a history of anal HPV infection who have undergone anal dysplasia screening.
Not a fit: Patients who do not have a history of anal HPV infection or have not undergone anal dysplasia screening may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate detection of anal precancers and cancers, improving patient outcomes.
How similar studies have performed: While the use of ctHPVDNA for other HPV-associated cancers has shown promise, its application specifically for anal cancer screening is relatively novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Past or current anal HPV-positive population undergone anal dysplasia screening. * Control patients from the general population. Exclusion Criteria: * Not meeting inclusion criteria.
Where this trial is running
Boston, Massachusetts
- Department of Infectious Diseases, Mass General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Daniel L. Faden, M.D. — Massachusetts General Hospital
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.