laboratory biomarker analysis for Anal Cancer
UCLA CARE Clinic, Los Angeles, CA
Targeting 4 different conditionslaboratory biomarker analysis +6 morePhase 3Waitlist AvailableLed by Joel Palefsky, MDResearch Sponsored by AIDS Malignancy ConsortiumEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Life expectancy of greater than 5 years
Life expectancy of greater than 5 years
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upa-hrsi completion occurred at 3 time points: pre-randomization (t1), within 2-7 days (t2) and at 4 weeks of treatment/randomization (t3).
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial
No Placebo-Only Group
Study Summary
This trial is comparing two different ways to prevent anal cancer in patients with HIV and high-grade squamous intraepithelial lesions (HSIL). The first way is called topical or ablative treatment. The second way is called active monitoring. The trial is almost finished, and the data shows that the first way is better at preventing anal cancer. So all the people in the trial are being offered the first way of treatment.
Eligible Conditions
- Anal Cancer
- Squamous Intraepithelial Lesion
- Human Papillomavirus
- HIV/AIDS
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You are expected to live for at least 5 more years.
Select...
You are expected to live for at least 5 more years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ a-hrsi completion occurred at 3 time points: pre-randomization (t1), within 2-7 days (t2) and at 4 weeks of treatment/randomization (t3).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~a-hrsi completion occurred at 3 time points: pre-randomization (t1), within 2-7 days (t2) and at 4 weeks of treatment/randomization (t3).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anal Cancer Incidence
Secondary outcome measures
Change in Physical Symptom Score From Baseline (2-7 Days Post Randomization) Until 4 Weeks Post Randomization
Incidence of Adverse Events for Each Treatment
Other outcome measures
ANCHOR Study Health-Related Symptom Index (A-HRSI) Scale Responsiveness (Sensitivity to Change)
Behavioral Risk Factors for HSIL Progression to Cancer
Host Factors in HSIL Progression to Cancer
+3 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (treatment)Experimental Treatment7 Interventions
Patients are directed to receive either topical or ablative treatment at the discretion of the clinician. Patients receiving topical treatment apply imiquimod intra-anally, peri-anally or both thrice weekly for up to 16 weeks, fluorouracil twice daily for 5 days every 2 weeks for up to 16 weeks, or trichloroacetic acid every 3 weeks up to 12 weeks. Patients receiving ablative treatment using infrared photocoagulation therapy, hyfrecation/electrocautery (thermal ablation therapy), or laser therapy. Patients may undergo excision under anesthesia if the clinician believes none of the other treatment approaches will be effective. The number and timing of such treatments will be at the discretion of the investigator. Patients with persistent HSIL should continue a protocol-approved treatment or a new protocol treatment should be considered. All participants will have samples collected for laboratory biomarker analysis.
Group II: Arm II (active monitoring) (closed since SEP2021)Active Control2 Interventions
Patients undergo active monitoring with examinations for clinical observation every 6 months. Every 12 months, patients undergo biopsies of visible lesions. Patients have cytology sampling performed at every visit. All participants will have samples collected for laboratory biomarker analysis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
FDA approved
infrared photocoagulation therapy
2011
Completed Phase 3
~140
laser therapy
2008
Completed Phase 2
~520
Imiquimod
FDA approved
Find a site
Who is running the clinical trial?
AIDS Malignancy ConsortiumLead Sponsor
63 Previous Clinical Trials
5,181 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,369 Previous Clinical Trials
41,210,819 Total Patients Enrolled
University of ArkansasOTHER
471 Previous Clinical Trials
143,309 Total Patients Enrolled
University of California, San FranciscoOTHER
2,388 Previous Clinical Trials
12,253,807 Total Patients Enrolled
University of ArizonaOTHER
488 Previous Clinical Trials
141,320 Total Patients Enrolled
The Emmes Company, LLCIndustry Sponsor
139 Previous Clinical Trials
1,045,880 Total Patients Enrolled
Joel Palefsky, MDPrincipal Investigator
AIDS Malignancy Consortium8 Previous Clinical Trials
3,812 Total Patients Enrolled
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please list other examples of scientific research that have used laboratory biomarkers?
"Out of the 351 active clinical trials concerning laboratory biomarker analysis, 111 are in Phase 3. Although a large portion of these studies are based in Houston, Texas, there are 19,117 locations worldwide where these trials are taking place."
Answered by AI
What can laboratory biomarker analysis be used to predict or diagnose?
"While laboratory biomarker analysis is most commonly used to treat superficial basal cell carcinoma, it has also been effective in treating rectal carcinoma, communicable diseases, and scalp structure."
Answered by AI
Are there risks inherent to laboratory biomarker analysis?
"There is some data to support the efficacy of laboratory biomarker analysis, as well as multiple rounds of data to support its safety. Therefore, our team has given it a score of 3."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
How old are they?
18 - 65
What site did they apply to?
Grady Health System
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies