Anal DysplasiaSCAN-LITENCT06971276
Assessing the Utility of Plasma ctHPVDNA for Anal Cancer Screening
An observational study of Anal Dysplasia, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
The study is to test a liquid biopsy assay for screening and classifying anal dysplasia from blood. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anal Dysplasia
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergone screening for anal dysplasia and control patients from the general population.
Who may be able to join
- Past or current anal HPV-positive population undergone anal dysplasia screening.
- Control patients from the general population.
Who cannot join
- Not meeting inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Infectious Diseases, Mass General Hospital
Boston, Massachusetts, 02114
About this study
The study is to test a liquid biopsy assay for screening and classifying anal dysplasia from blood.
Read the detailed description
Anal squamous cell carcinoma, despite being considered as a rare cancer, has seen a steady rise in incidence over the past three decades. Recent evidence from the Anal Cancer-HSIL Outcomes Research (ANCHOR) study demonstrated benefits of treating anal high-grade squamous intraepithelial lesion (HSIL), highlighting the importance of screening anal cancers and high-grade precancers. Current anal cancer screening starts with HPV testing and/or cytology for primary screening, followed by high-resolution anoscopy (HRA) with biopsy for confirmatory diagnosis. However, the poor specificity of HPV testing and the extremely limited capacity of HRA urges the development of new screening approaches for identifying anal high-grade precancers and cancers. Blood circulating tumor HPV DNA (ctHPVDNA) is an emerging non-invasive biomarker for screening and treatment monitoring of HPV-associated cancers, but its significance in anal cases remains underexplored. Here the investigators use an ultrasensitive HPV whole genome sequencing assay to test the hypothesis that anal precancers are detectable in the blood.
- Conditions
- Anal Dysplasia
- Keywords
- HPV, Liquid biopsy, Anal cancer, Anal intraepithelial neoplasia, Early cancer detection, HPV-DeepSeek, NGS
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anal cancer | Screening patients diagnosed with anal squamous cell carcinoma (ASCC) | |
| AIN3 | Screening patients diagnosed with anal intraepithelial neoplasia 3 (AIN3) | |
| AIN2 | Screening patients diagnosed with anal intraepithelial neoplasia 2 (AIN2) | |
| AIN1 | Screening patients diagnosed with anal intraepithelial neoplasia 1 (AIN1) | |
| HPV Infection | Screening patients diagnosed with HPV infection (no lesion) | |
| Controls | Screening patients diagnosed negative for HPV and control patients from the general population. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer Developmental Stage
Anal dysplasia screening results based on tissue biopsy collected at time of the visit or clinical diagnosis when biopsy is not available.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start3 Apr 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel L. Faden, MD, Massachusetts General Hospital
- Investigators
- Daniel L. Faden, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971276
- Sponsor's protocol ID
- 18-469
- Acronym
- SCAN-LITE
- Status last verified
- Apr 2026
- First submitted
- 5 May 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Utility of Plasma ctHPVDNA for Anal Cancer Screening
- ClinicalTrials.gov ID
- NCT06971276
- Acronym / sponsor ID
- SCAN-LITE / 18-469
- Conditions
- Anal Dysplasia
- Keywords
- HPV, Liquid biopsy, Anal cancer, Anal intraepithelial neoplasia, Early cancer detection, HPV-DeepSeek, NGS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is to test a liquid biopsy assay for screening and classifying anal dysplasia from blood.
Detailed description
Anal squamous cell carcinoma, despite being considered as a rare cancer, has seen a steady rise in incidence over the past three decades. Recent evidence from the Anal Cancer-HSIL Outcomes Research (ANCHOR) study demonstrated benefits of treating anal high-grade squamous intraepithelial lesion (HSIL), highlighting the importance of screening anal cancers and high-grade precancers. Current anal cancer screening starts with HPV testing and/or cytology for primary screening, followed by high-resolution anoscopy (HRA) with biopsy for confirmatory diagnosis. However, the poor specificity of HPV testing and the extremely limited capacity of HRA urges the development of new screening approaches for identifying anal high-grade precancers and cancers. Blood circulating tumor HPV DNA (ctHPVDNA) is an emerging non-invasive biomarker for screening and treatment monitoring of HPV-associated cancers, but its significance in anal cases remains underexplored. Here the investigators use an ultrasensitive HPV whole genome sequencing assay to test the hypothesis that anal precancers are detectable in the blood.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Anal cancer | – | –Screening patients diagnosed with anal squamous cell carcinoma (ASCC) |
| AIN3 | – | –Screening patients diagnosed with anal intraepithelial neoplasia 3 (AIN3) |
| AIN2 | – | –Screening patients diagnosed with anal intraepithelial neoplasia 2 (AIN2) |
| AIN1 | – | –Screening patients diagnosed with anal intraepithelial neoplasia 1 (AIN1) |
| HPV Infection | – | –Screening patients diagnosed with HPV infection (no lesion) |
| Controls | – | –Screening patients diagnosed negative for HPV and control patients from the general population. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergone screening for anal dysplasia and control patients from the general population.
Key inclusion criteria (2 listed)
- Past or current anal HPV-positive population undergone anal dysplasia screening.
- Control patients from the general population.
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cancer Developmental Stage
Time frame: Periprocedural
Anal dysplasia screening results based on tissue biopsy collected at time of the visit or clinical diagnosis when biopsy is not available.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Anal Dysplasia
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Epidemiology of Anal Human Papillomavirus Carriage in Female Solid Organ Transplant Recipients With More Than 10 Years of Immunosuppression
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Screening Algorithms for Cervical and Anal High-Grade Squamous Intraepithelial Lesions in People With HIV in Mexico and Puerto Rico
AIDS-Related Anal Carcinoma, AIDS-Related Cervical Carcinoma
Not yet recruitingPhase 1
Use of ACU-D1 in HPV Associated Vulvar and Perianal Lesions in People With HIV
Human Papilloma Virus, Human Immunodeficiency Virus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel L. Faden, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Dysplasia, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer Developmental Stage (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.