Anal Intraepithelial Neoplasia (AIN) in HIV-infected PatientsTECAINNCT02615860

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

A study testing Topical 85% trichloroacetic acid (TCA) and Surgical electrocautery (ECA) in people with Anal Intraepithelial Neoplasia (AIN) in HIV-infected Patients, run by University Hospital, Essen at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Anal Intraepithelial Neoplasia (AIN) in HIV-infected Patients
What is being tested?: Topical 85% trichloroacetic acid (TCA) and Surgical electrocautery (ECA)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 560 participants
Where: 1 siteGermany
Study dates: Nov 2015to 31 Dec 2021
Phase: Interventional
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
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

Universitätsklinikum Essen, Klinik für Dermatologie
Essen, Nordrheinwestfalen, 45147

Other trials in Germany

About this study

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

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.

Read the 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.

Conditions: Anal Intraepithelial Neoplasia (AIN) in HIV-infected Patients
Being tested: Topical 85% trichloroacetic acid (TCA), Surgical electrocautery (ECA)
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.
Medical subject headings: Acquired Immunodeficiency Syndrome, Anus Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Topical 85% trichloroacetic acid (TCA)Other
Also called Topical treatment with trichloroacetic acid (TCA)
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
Surgical electrocautery (ECA)Procedure or surgery
Also called Device: Electrocauter
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

Study groups in NCT02615860
Study group	Role	What they receive
Topical 85% trichloroacetic acid (TCA)	Experimental	AIN lesions are treated with trichloric acid Receives: Other: Topical 85% trichloroacetic acid (TCA)
Surgical electrocautery (ECA)	Active comparator	AIN lesions are treated with electrocautery Receives: Procedure: Surgical electrocautery (ECA)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Four weeks after the last treatment within TECAIN

Secondary outcomes (8)

Recurrence of AIN at the previously treated sites
Measured: 24 weeks after the end of TECAIN treatment
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
Measured: 4 weeks after the end of TECAIN treatment
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
Measured: Up to 16 weeks after study start
Anal HPV types, HPV multiplicity, HPV DNA load and HPV oncogene mRNA
Measured: Baseline, 4 and 24 weeks after the end of TECAIN treatment
Recurrence of AIN or new lesions
Measured: 6 months after completion of TECAIN treatment in previously treated areas
Duration of treatment phase
Measured: 24 weeks after the end of TECAIN treatment
Adverse events
Measured: During the whole study up to 36 weeks
Treatment costs
Measured: 24 weeks after the end of TECAIN treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 201531 Dec 2021

First posted26 Nov 2015 (estimated)
Study startNov 2015
Primary completion31 Mar 2020
Study completion31 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (30)Papers the sponsor has linked to this study.
Other trials for Anal Intraepithelial Neoplasia (AIN) in HIV-infected PatientsStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 560 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02615860
Sponsor's protocol ID: 01KG1425
Acronym: TECAIN
Status last verified: Nov 2022
First submitted: 19 Nov 2015
Last updated: 8 Nov 2022
Results posted: No
Data monitoring committee: Yes

Publications

Berry JM, Jay N, Cranston RD, Darragh TM, Holly EA, Welton ML, Palefsky JM. Progression of anal high-grade squamous intraepithelial lesions to invasive anal cancer among HIV-infected men who have sex with men. Int J Cancer. 2014 Mar 1;134(5):1147-55. doi: 10.1002/ijc.28431. Epub 2013 Sep 14.
PubMed 23934991
de Pokomandy A, Rouleau D, Ghattas G, Trottier H, Vezina S, Cote P, Macleod J, Allaire G, Hadjeres R, Franco EL, Coutlee F. HAART and progression to high-grade anal intraepithelial neoplasia in men who have sex with men and are infected with HIV. Clin Infect Dis. 2011 May;52(9):1174-81. doi: 10.1093/cid/cir064. Epub 2011 Mar 1.
PubMed 21364075
Fox PA, Nathan M, Francis N, Singh N, Weir J, Dixon G, Barton SE, Bower M. A double-blind, randomized controlled trial of the use of imiquimod cream for the treatment of anal canal high-grade anal intraepithelial neoplasia in HIV-positive MSM on HAART, with long-term follow-up data including the use of open-label imiquimod. AIDS. 2010 Sep 24;24(15):2331-5. doi: 10.1097/QAD.0b013e32833d466c.
PubMed 20729710
Fox PA. Treatment options for anal intraepithelial neoplasia and evidence for their effectiveness. Sex Health. 2012 Dec;9(6):587-92. doi: 10.1071/SH11157.
PubMed 22951292
Goldie SJ, Kuntz KM, Weinstein MC, Freedberg KA, Welton ML, Palefsky JM. The clinical effectiveness and cost-effectiveness of screening for anal squamous intraepithelial lesions in homosexual and bisexual HIV-positive men. JAMA. 1999 May 19;281(19):1822-9. doi: 10.1001/jama.281.19.1822.
PubMed 10340370
Heitland W, Schadlich PK, Chen X, Remy V, Moro L. Annual cost of hospitalization, inpatient rehabilitation and sick leave of anal cancer in Germany. J Med Econ. 2013;16(3):364-71. doi: 10.3111/13696998.2012.759582. Epub 2013 Jan 2.
PubMed 23253056
Hessol NA, Holly EA, Efird JT, Minkoff H, Weber KM, Darragh TM, Burk RD, Strickler HD, Greenblatt RM, Palefsky JM. Concomitant anal and cervical human papillomavirusV infections and intraepithelial neoplasia in HIV-infected and uninfected women. AIDS. 2013 Jul 17;27(11):1743-51. doi: 10.1097/QAD.0b013e3283601b09.
PubMed 23803793
Julious SA, Campbell MJ. Tutorial in biostatistics: sample sizes for parallel group clinical trials with binary data. Stat Med. 2012 Oct 30;31(24):2904-36. doi: 10.1002/sim.5381. Epub 2012 Jun 19.
PubMed 22714646
Kreuter A, Potthoff A, Brockmeyer NH, Gambichler T, Stucker M, Altmeyer P, Swoboda J, Pfister H, Wieland U; German Competence Network HIV/AIDS. Imiquimod leads to a decrease of human papillomavirus DNA and to a sustained clearance of anal intraepithelial neoplasia in HIV-infected men. J Invest Dermatol. 2008 Aug;128(8):2078-83. doi: 10.1038/jid.2008.24. Epub 2008 Feb 14.
PubMed 18273049
Kreuter A, Wieland U. Human papillomavirus-associated diseases in HIV-infected men who have sex with men. Curr Opin Infect Dis. 2009 Apr;22(2):109-14. doi: 10.1097/QCO.0b013e3283229fc8.
PubMed 19276878
Kreuter A, Potthoff A, Brockmeyer NH, Gambichler T, Swoboda J, Stucker M, Schmitt M, Pfister H, Wieland U; German Competence Network HIV/AIDS. Anal carcinoma in human immunodeficiency virus-positive men: results of a prospective study from Germany. Br J Dermatol. 2010 Jun;162(6):1269-77. doi: 10.1111/j.1365-2133.2010.09712.x. Epub 2010 Feb 22.
PubMed 20184584
Lam JM, Hoch JS, Tinmouth J, Sano M, Raboud J, Salit IE. Cost-effectiveness of screening for anal precancers in HIV-positive men. AIDS. 2011 Mar 13;25(5):635-42. doi: 10.1097/QAD.0b013e3283434594.
PubMed 21139488
Legarth R, Helleberg M, Kronborg G, Larsen CS, Pedersen G, Pedersen C, Jensen J, Nielsen LN, Gerstoft J, Obel N. Anal carcinoma in HIV-infected patients in the period 1995-2009: a Danish nationwide cohort study. Scand J Infect Dis. 2013 Jun;45(6):453-9. doi: 10.3109/00365548.2012.737476. Epub 2013 Jan 7.
PubMed 23294033
Macaya A, Munoz-Santos C, Balaguer A, Barbera MJ. Interventions for anal canal intraepithelial neoplasia. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD009244. doi: 10.1002/14651858.CD009244.pub2.
PubMed 23235673
Machalek DA, Poynten M, Jin F, Fairley CK, Farnsworth A, Garland SM, Hillman RJ, Petoumenos K, Roberts J, Tabrizi SN, Templeton DJ, Grulich AE. Anal human papillomavirus infection and associated neoplastic lesions in men who have sex with men: a systematic review and meta-analysis. Lancet Oncol. 2012 May;13(5):487-500. doi: 10.1016/S1470-2045(12)70080-3. Epub 2012 Mar 23.
PubMed 22445259

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02615860
Acronym / sponsor ID: TECAIN / 01KG1425
Conditions: 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)
Study type: Interventional
Recruitment status: Completed
Enrolment: 560 participants (actual)
Lead sponsor: University Hospital, EssenUniversity, hospital or other
Study start: Nov 2015 (actual)
Primary completion: 31 Mar 2020 (actual)
Study completion: 31 Dec 2021 (actual)
First posted: 26 Nov 2015 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Topical 85% trichloroacetic acid (TCA)	Experimental	Other: Topical 85% trichloroacetic acid (TCA)AIN lesions are treated with trichloric acid
Surgical electrocautery (ECA)	Active comparator	Procedure: Surgical electrocautery (ECA)AIN lesions are treated with electrocautery

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Topical 85% trichloroacetic acid (TCA)Also: Topical treatment with trichloroacetic acid (TCA)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	Other	Topical 85% trichloroacetic acid (TCA)
Surgical electrocautery (ECA)Also: Device: ElectrocauterIn 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	Procedure or surgery	Surgical electrocautery (ECA)

Primary outcome

Therapeutic success (success rate) defined as clinically (HRA) and histologically confirmed resolution (normal histology) or regression (from AIN2/3 to AIN1) of AIN
Time frame: Four weeks after the last treatment within TECAIN
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.

8 secondary outcomes

Recurrence of AIN at the previously treated sites
Time frame: 24 weeks after the end of TECAIN treatment
Number of interventions needed during the 12 weeks TECAIN treatment period.
Time frame: 4 weeks after the end of TECAIN treatment
Pain of the proctologic AIN treatments
Time frame: Up to 16 weeks after study start
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
Recurrence of AIN or new lesions
Time frame: 6 months after completion of TECAIN treatment in previously treated areas
Duration of treatment phase
Time frame: 24 weeks after the end of TECAIN treatment
Adverse events
Time frame: During the whole study up to 36 weeks
Treatment costs
Time frame: 24 weeks after the end of TECAIN treatment

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 8 Nov 2022.
Background: PubMed 23934991Berry JM, Jay N, Cranston RD, Darragh TM, Holly EA, Welton ML, Palefsky JM. Progression of anal high-grade squamous intraepithelial lesions to invasive anal cancer among HIV-infected men who have sex with men. Int J Cancer. 2014 Mar 1;134(5):1147-55. doi: 10.1002/ijc.28431. Epub 2013 Sep 14.
Background: PubMed 21364075de Pokomandy A, Rouleau D, Ghattas G, Trottier H, Vezina S, Cote P, Macleod J, Allaire G, Hadjeres R, Franco EL, Coutlee F. HAART and progression to high-grade anal intraepithelial neoplasia in men who have sex with men and are infected with HIV. Clin Infect Dis. 2011 May;52(9):1174-81. doi: 10.1093/cid/cir064. Epub 2011 Mar 1.
Background: PubMed 20729710Fox PA, Nathan M, Francis N, Singh N, Weir J, Dixon G, Barton SE, Bower M. A double-blind, randomized controlled trial of the use of imiquimod cream for the treatment of anal canal high-grade anal intraepithelial neoplasia in HIV-positive MSM on HAART, with long-term follow-up data including the use of open-label imiquimod. AIDS. 2010 Sep 24;24(15):2331-5. doi: 10.1097/QAD.0b013e32833d466c.
Background: PubMed 22951292Fox PA. Treatment options for anal intraepithelial neoplasia and evidence for their effectiveness. Sex Health. 2012 Dec;9(6):587-92. doi: 10.1071/SH11157.
Background: PubMed 10340370Goldie SJ, Kuntz KM, Weinstein MC, Freedberg KA, Welton ML, Palefsky JM. The clinical effectiveness and cost-effectiveness of screening for anal squamous intraepithelial lesions in homosexual and bisexual HIV-positive men. JAMA. 1999 May 19;281(19):1822-9. doi: 10.1001/jama.281.19.1822.
Background: PubMed 23253056Heitland W, Schadlich PK, Chen X, Remy V, Moro L. Annual cost of hospitalization, inpatient rehabilitation and sick leave of anal cancer in Germany. J Med Econ. 2013;16(3):364-71. doi: 10.3111/13696998.2012.759582. Epub 2013 Jan 2.
Background: PubMed 23803793Hessol NA, Holly EA, Efird JT, Minkoff H, Weber KM, Darragh TM, Burk RD, Strickler HD, Greenblatt RM, Palefsky JM. Concomitant anal and cervical human papillomavirusV infections and intraepithelial neoplasia in HIV-infected and uninfected women. AIDS. 2013 Jul 17;27(11):1743-51. doi: 10.1097/QAD.0b013e3283601b09.
Background: PubMed 22714646Julious SA, Campbell MJ. Tutorial in biostatistics: sample sizes for parallel group clinical trials with binary data. Stat Med. 2012 Oct 30;31(24):2904-36. doi: 10.1002/sim.5381. Epub 2012 Jun 19.
Background: PubMed 18273049Kreuter A, Potthoff A, Brockmeyer NH, Gambichler T, Stucker M, Altmeyer P, Swoboda J, Pfister H, Wieland U; German Competence Network HIV/AIDS. Imiquimod leads to a decrease of human papillomavirus DNA and to a sustained clearance of anal intraepithelial neoplasia in HIV-infected men. J Invest Dermatol. 2008 Aug;128(8):2078-83. doi: 10.1038/jid.2008.24. Epub 2008 Feb 14.
Background: PubMed 19276878Kreuter A, Wieland U. Human papillomavirus-associated diseases in HIV-infected men who have sex with men. Curr Opin Infect Dis. 2009 Apr;22(2):109-14. doi: 10.1097/QCO.0b013e3283229fc8.
Background: PubMed 20184584Kreuter A, Potthoff A, Brockmeyer NH, Gambichler T, Swoboda J, Stucker M, Schmitt M, Pfister H, Wieland U; German Competence Network HIV/AIDS. Anal carcinoma in human immunodeficiency virus-positive men: results of a prospective study from Germany. Br J Dermatol. 2010 Jun;162(6):1269-77. doi: 10.1111/j.1365-2133.2010.09712.x. Epub 2010 Feb 22.
Background: PubMed 21139488Lam JM, Hoch JS, Tinmouth J, Sano M, Raboud J, Salit IE. Cost-effectiveness of screening for anal precancers in HIV-positive men. AIDS. 2011 Mar 13;25(5):635-42. doi: 10.1097/QAD.0b013e3283434594.
Esser et al. DAIG-Leitlinie: Anale Dysplasien u. Analkarzinome bei HIV-Infizierten: Prävention, Diagnostik u.Link provided by the sponsor.

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 13 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 8 Nov 2022. 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 Germany. 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?

Therapeutic success (success rate) defined as clinically (HRA) and histologically confirmed resolution (normal histology) or regression (from AIN2/3 to AIN1) of AIN (time frame: Four weeks after the last treatment within TECAIN). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02615860, which also lists 30 linked publications.

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 8 Nov 2022.