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Efficacy and Safety of TCA vs. ECA for the Treatment of AIN in HIV-positive Patients (TECAIN)

Primary Purpose

Anal Intraepithelial Neoplasia (AIN) in HIV-infected Patients

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Topical 85% trichloroacetic acid (TCA)
Surgical electrocautery (ECA)
Sponsored by
University Hospital, Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Intraepithelial Neoplasia (AIN) in HIV-infected Patients focused on measuring HIV-infection, anal cancer (AC), anal cancer prevention, anal dysplasia, anal intraepithelial neoplasia (AIN), human papillomavirus (HPV), HPV-induced anal cancer precursor lesions, electrocautery (ECA), topical trichloroacetic acid (TCA) treatment.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV positive patients
  • Legally eligible patients and age ≥ 18 years
  • Sufficient knowledge of the German language, spoken and written
  • Patient is willing and able to appear regularly to the treatment- and follow-up appointments
  • Clinically visible AIN-lesion, which was confirmed by histopathology (findings not older than 2 weeks after the date of collection and removal date no longer than 16 weeks prior to baseline)
  • Written informed consent

Exclusion Criteria:

  • Currently diagnosed anal cancer or anal cancer in anamnesis (within the last 5 years)
  • Acute life-threatening disease
  • Participation in a proctologic study within the last 30 days
  • Participation in this study at an earlier date
  • Simultaneous participation in another clinical trial, which excludes the participation in this study
  • Simultaneous topical and systemic treatments wtih medications that affect the study outcome, such as immunomodulatory substances: Interferone, imiquimod or systemic glucocorticosteroids
  • lactation
  • Pregnancy: In patients of childbearing age, a pregnancy has to be ruled out by pregnancy test or other suitable methods.
  • Women of childbearing potential without adequate contraceptive protection.
  • Contraindication for using trichloroacetic acid or electrocautery
  • Patients in whom general anesthesia in the treatment of AIN is necessary already at study start
  • Other serious intra-anal and proctologic disorders, which make additional proctologic or systemic treatments necessary, which influence the study result, such as an active Crohn's disease, which must be treated locally and systemically with immunosuppressives or an active proctitis.
  • Patients who have been vaccinated before baseline against HPV

Sites / Locations

  • Universitätsklinikum Essen, Klinik für Dermatologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Topical 85% trichloroacetic acid (TCA)

Surgical electrocautery (ECA)

Arm Description

AIN lesions are treated with trichloric acid

AIN lesions are treated with electrocautery

Outcomes

Primary Outcome Measures

Therapeutic success (success rate) defined as clinically (HRA) and histologically confirmed resolution (normal histology) or regression (from AIN2/3 to AIN1) of AIN
The primary endpoint is therapeutic success (success rate) defined as clinically (HRA) and histologically confirmed resolution (normal histology) or regression (from AIN 2/3 to AIN1) of AIN four weeks after the last treatment within TECAIN. Patients not showing up at this mandatory follow-up appointment will be counted as treatment failure. Histologically confirmed resolution/regression 4 (to 8) weeks after therapy has been the primary endpoint in the two published RCTs and in several pilot studies. Clearance of AIN after treatment is the most relevant endpoint for patients, since AIN can rapidly progress to AC in HIV+ patients.

Secondary Outcome Measures

Recurrence of AIN at the previously treated sites
Number of interventions needed during the 12 weeks TECAIN treatment period.
Additional treatments are possible after baseline, but they are not mandatory, if the lesions are cleared. So 4 weeks after each treatment the investigator checks, if the lesions are cleared and decides if he does another treatment or if the patient can progress to the follow up
Pain of the proctologic AIN treatments
Additional treatments are possible after baseline, but they are not mandatory, if the lesions are cleared. So 4 weeks after each treatment the investigator checks, if the lesions are cleared and decides if he does another treatment or if the patient can progress to the follow up
Anal HPV types, HPV multiplicity, HPV DNA load and HPV oncogene mRNA
Recurrence of AIN or new lesions
Duration of treatment phase
Adverse events
Treatment costs

Full Information

First Posted
November 19, 2015
Last Updated
November 7, 2022
Sponsor
University Hospital, Essen
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1. Study Identification

Unique Protocol Identification Number
NCT02615860
Brief Title
Efficacy and Safety of TCA vs. ECA for the Treatment of AIN in HIV-positive Patients
Acronym
TECAIN
Official Title
Efficacy and Safety of Topical Trichloroacetic Acid vs. Electrocautery for the Treatment of Anal Intraepithelial Neoplasia in HIV-positive Patients (TECAIN) - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Essen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Comparative evaluation of efficacy and safety of high-resolution anoscopy (HRA)-guided topical treatment (trichloroacetic acid, TCA) vs. surgical treatment (electrocautery, ECA) in HIV-positive patients for human papillomavirus (HPV)- induced AIN, an anal cancer precursor. The primary hypothesis is that cost-saving and simple TCA treatment is non-inferior to the current best option therapy with ECA. TCA treatment would also be possible in the normal setting of a doctor´s office without extensive specialization and without complex technical equipment.
Detailed Description
Anal human papillomavirus (HPV)-infection and HPV-induced AIN, an anal cancer precursor, are very frequent in HIV-positive patients (HIV+), especially in men who have sex with men (MSM), but also in women. Consequently, HIV+ have a strongly increased risk for anal cancer. Screening for and treatment of AIN are recommended in HIV+, although only two RCT on AIN treatment have been published. We plan a multicenter, unblinded, non-inferiority RCT that evaluates the efficacy and safety of 2 high-resolution anoscopy (HRA)-guided treatment options for AIN: topical application of trichloroacetic acid (TCA) and surgical treatment with electrocautery (ECA). ECA was the best option for intra-anal AIN in a recent randomized controlled trial (RCT). TCA, an inexpensive and established therapy for genital warts, has been evaluated for AIN only in a retrospective pilot study that showed clearance rates comparable to those found for ECA, with possibly less adverse events (AE). Our primary hypothesis is that cost-saving and simple TCA is non-inferior to ECA. 2800 HIV+ will be screened by HRA in 9 proctological centers and 560 HIV+ with histologically confirmed intra-anal AIN will be randomized (1:1) to receive up to 4 treatments with TCA or ECA within 12 weeks. The primary efficacy endpoint is clinical (HRA) and histological resolution of AIN 4 weeks after the last treatment. Secondary endpoints comprise recurrence of AIN 24 weeks after end of therapy, the number of interventions, AE, and the influence of HPV parameters such as anal HPV-types, viral load and HPV-oncogene-mRNA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Intraepithelial Neoplasia (AIN) in HIV-infected Patients
Keywords
HIV-infection, anal cancer (AC), anal cancer prevention, anal dysplasia, anal intraepithelial neoplasia (AIN), human papillomavirus (HPV), HPV-induced anal cancer precursor lesions, electrocautery (ECA), topical trichloroacetic acid (TCA) treatment.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
560 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topical 85% trichloroacetic acid (TCA)
Arm Type
Experimental
Arm Description
AIN lesions are treated with trichloric acid
Arm Title
Surgical electrocautery (ECA)
Arm Type
Active Comparator
Arm Description
AIN lesions are treated with electrocautery
Intervention Type
Other
Intervention Name(s)
Topical 85% trichloroacetic acid (TCA)
Other Intervention Name(s)
Topical treatment with trichloroacetic acid (TCA)
Intervention Description
In the experimental intervention arm, all visible lesions are treated with 85% TCA by dipping the wooden stick end of a cotton swab into a cup containing TCA. The stick end is saturated with TCA and is inserted through the anoscope and directed to the lesion under HRA guidance. TCA is applied to the lesion repeatedly until the lesion changes to a dense white colour. Each TCA application session is followed by another appointment four weeks later, where the clinician re-evaluates the lesions of the patient and determines whether a next TCA application is necessary up to a maximum of four times
Intervention Type
Procedure
Intervention Name(s)
Surgical electrocautery (ECA)
Other Intervention Name(s)
Device: Electrocauter
Intervention Description
In the control arm, HRA-guided ECA, is performed every 4 weeks up to a maximum of four times. All visible lesions are ablated at every visit. Bleeding from small vessels can be stopped by ECA. Patients undergo local anaesthesia if necessary
Primary Outcome Measure Information:
Title
Therapeutic success (success rate) defined as clinically (HRA) and histologically confirmed resolution (normal histology) or regression (from AIN2/3 to AIN1) of AIN
Description
The primary endpoint is therapeutic success (success rate) defined as clinically (HRA) and histologically confirmed resolution (normal histology) or regression (from AIN 2/3 to AIN1) of AIN four weeks after the last treatment within TECAIN. Patients not showing up at this mandatory follow-up appointment will be counted as treatment failure. Histologically confirmed resolution/regression 4 (to 8) weeks after therapy has been the primary endpoint in the two published RCTs and in several pilot studies. Clearance of AIN after treatment is the most relevant endpoint for patients, since AIN can rapidly progress to AC in HIV+ patients.
Time Frame
Four weeks after the last treatment within TECAIN
Secondary Outcome Measure Information:
Title
Recurrence of AIN at the previously treated sites
Time Frame
24 weeks after the end of TECAIN treatment
Title
Number of interventions needed during the 12 weeks TECAIN treatment period.
Description
Additional treatments are possible after baseline, but they are not mandatory, if the lesions are cleared. So 4 weeks after each treatment the investigator checks, if the lesions are cleared and decides if he does another treatment or if the patient can progress to the follow up
Time Frame
4 weeks after the end of TECAIN treatment
Title
Pain of the proctologic AIN treatments
Description
Additional treatments are possible after baseline, but they are not mandatory, if the lesions are cleared. So 4 weeks after each treatment the investigator checks, if the lesions are cleared and decides if he does another treatment or if the patient can progress to the follow up
Time Frame
Up to 16 weeks after study start
Title
Anal HPV types, HPV multiplicity, HPV DNA load and HPV oncogene mRNA
Time Frame
Baseline, 4 and 24 weeks after the end of TECAIN treatment
Title
Recurrence of AIN or new lesions
Time Frame
6 months after completion of TECAIN treatment in previously treated areas
Title
Duration of treatment phase
Time Frame
24 weeks after the end of TECAIN treatment
Title
Adverse events
Time Frame
During the whole study up to 36 weeks
Title
Treatment costs
Time Frame
24 weeks after the end of TECAIN treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV positive patients Legally eligible patients and age ≥ 18 years Sufficient knowledge of the German language, spoken and written Patient is willing and able to appear regularly to the treatment- and follow-up appointments Clinically visible AIN-lesion, which was confirmed by histopathology (findings not older than 2 weeks after the date of collection and removal date no longer than 16 weeks prior to baseline) Written informed consent Exclusion Criteria: Currently diagnosed anal cancer or anal cancer in anamnesis (within the last 5 years) Acute life-threatening disease Participation in a proctologic study within the last 30 days Participation in this study at an earlier date Simultaneous participation in another clinical trial, which excludes the participation in this study Simultaneous topical and systemic treatments wtih medications that affect the study outcome, such as immunomodulatory substances: Interferone, imiquimod or systemic glucocorticosteroids lactation Pregnancy: In patients of childbearing age, a pregnancy has to be ruled out by pregnancy test or other suitable methods. Women of childbearing potential without adequate contraceptive protection. Contraindication for using trichloroacetic acid or electrocautery Patients in whom general anesthesia in the treatment of AIN is necessary already at study start Other serious intra-anal and proctologic disorders, which make additional proctologic or systemic treatments necessary, which influence the study result, such as an active Crohn's disease, which must be treated locally and systemically with immunosuppressives or an active proctitis. Patients who have been vaccinated before baseline against HPV
Facility Information:
Facility Name
Universitätsklinikum Essen, Klinik für Dermatologie
City
Essen
State/Province
Nordrheinwestfalen
ZIP/Postal Code
45147
Country
Germany

12. IPD Sharing Statement

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http://www.awmf.org/uploads/tx_szleitlinien/055-007l_S1k_Anale_Dysplasien_Analkarzinom_HIV_infizierten_09-2013__01.pdf
Description
Esser et al. DAIG-Leitlinie: Anale Dysplasien u. Analkarzinome bei HIV-Infizierten: Prävention, Diagnostik u.

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Efficacy and Safety of TCA vs. ECA for the Treatment of AIN in HIV-positive Patients

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