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Preventative Treatments for Anal Cancer Prevention in HIV Patients (ANCHOR Trial)

Q: 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, <a href="https://www.withpower.com/clinical-trials/texas">Texas</a>, there are 19,117 locations worldwide where these trials are taking place.

Q: 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.

Q: 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.

Phase 3

Waitlist Available

Led By Joel Palefsky, MD

Research Sponsored by AIDS Malignancy Consortium

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HIV positive with documentation of HIV-1 infection

Eastern Cooperative Oncology Group (ECOG) performance status <= 1

Timeline

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).

Awards & highlights

ANCHOR Trial 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.

Who is the study for?

This trial is for HIV-positive individuals with high-grade squamous intraepithelial lesions (HSIL) at risk of anal cancer. Participants must have a life expectancy over 5 years, acceptable organ function, and agree to use birth control. Excluded are those who've had HSIL treatment within the last 6 months or have extensive warts obscuring HSIL assessment.Check my eligibility

What is being tested?

The study compares topical/ablative treatments like fluorouracil and imiquimod, thermal ablation, laser therapy against active monitoring in preventing anal cancer among HIV patients with HSIL. After initial randomization phase completion, participants can choose treatment or follow-up.See study design

What are the potential side effects?

Potential side effects may include skin irritation from topical treatments, discomfort or pain from ablative therapies such as thermal ablation or laser therapy, and general risks associated with medical procedures like infection.

ANCHOR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am HIV positive with documented HIV-1 infection.

Select...

I am fully active and can carry on all my pre-disease activities without restriction.

Select...

I have a confirmed high-grade lesion not within a wart.

ANCHOR Trial 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).

This trial's timeline: 3 weeks for screening, Varies for treatment, and a-hrsi completion occurred at 3 time points: pre-randomization (t1), within 2-7 days (t2) and at 4 weeks of treatment/randomization (t3). for reporting.

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 more

ANCHOR 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

1994

Completed Phase 3

~8440

infrared photocoagulation therapy

2011

Completed Phase 3

~140

laser therapy

2008

Completed Phase 2

~550

imiquimod

2008

Completed Phase 3

~750

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,928,707 Total Patients Enrolled

University of California, San FranciscoOTHER

2,500 Previous Clinical Trials

15,232,025 Total Patients Enrolled

University of ArizonaOTHER

514 Previous Clinical Trials

143,825 Total Patients Enrolled

Media Library

laboratory biomarker analysis Clinical Trial Eligibility Overview. Trial Name: NCT02135419 — Phase 3

Anal Cancer Research Study Groups: Arm I (treatment), Arm II (active monitoring) (closed since SEP2021)

Anal Cancer Clinical Trial 2023: laboratory biomarker analysis Highlights & Side Effects. Trial Name: NCT02135419 — Phase 3

laboratory biomarker analysis 2023 Treatment Timeline for Medical Study. Trial Name: NCT02135419 — Phase 3

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