Condition category
Cancer
Date applied
15/07/2015
Date assigned
15/07/2015
Last edited
24/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information

Type

Public

Primary contact

Miss Jennifer Child

ORCID ID

http://orcid.org/0000-0001-5115-8164

Contact details

Homerton University Hospital
Homerton Row
London
E9 6SR
United Kingdom

Additional identifiers

EudraCT number

2015-002806-36

ClinicalTrials.gov number

Protocol/serial number

19230

Study information

Scientific title

A randomised controlled trial to study the effectiveness of Laser ablation versus Observation to Prevent Anal Cancer in men who have sex with men with human immunodeficiency virus infection who have high-grade anal intraepithelial neoplasia (AIN 2 and/or AIN 3) disease

Acronym

LOPAC

Study hypothesis

The LOPAC study will endeavor to answer the question if active treatment of high-grade AIN disease may prevent progression to anal cancer. This is the primary objective of the LOPAC trial.

On 28/09/2015 the overall trial end date was changed from 17/12/2021 to 30/09/2021.

Ethics approval

NRES Committee London – London Bridge, 02/07/2015, ref: 15/LO/0942

Study design

Randomised; Interventional and Observational; Design type: Diagnosis, Prevention, Screening, Treatment, Cohort study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Topic: Cancer; Subtopic: Colorectal Cancer; Disease: Anus

Intervention

The treatment being tested is laser ablation. This involves burning the skin/other similar lining using laser where anal precancer was identified and involves a local burn. Patients in the treatment arm will receive up to four courses of laser treatment during the trial period, performed by one of the clinicians at Homerton University Hospital NHS Foundation Trust.
Follow Up Length: 72 month(s); Study Entry : Single Randomisation only

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Incidence of anal cancer in treatment arm compared to observation arm through the trial period; Timepoint(s): Over course of trial = 72 months

Secondary outcome measures

For all enrolled participants:
1. The rates of AIN 2 and/or AIN 3 detected in the population enrolled into the study.; Timepoint(s): Over the course of trial = 72 months
2. Risk factors for AIN 2 and/or AIN 3 and knowledge about HPV and anal cancer in participants with AIN2 and/or AIN3, compared to those who screened negative for AIN2 and/or AIN3 disease.; Timepoint(s): Over the course of the trial = 72 months
For all randomised participants:
3. Proportion of clearance/regression/progression of high-grade AIN lesions in the treatment arm, compared to the observation arm.; Timepoint(s): Over the course of the trial = 72 months
4. Incidence of metachronous (new) lesions and the rate of recurrence of high-grade AIN disease after clearance in the treatment arm, compared to the observation arm.; Timepoint(s): Over the course of the trial = 72 months
5. Difference, if any, by quadrants of high-grade AIN disease in the treatment arm, compared to the observation arm as measured by the proportion of disease clearance/regression/progression.; Timepoint(s): Over the course of the trial = 72 months
6. Number of treatment episodes/treatment duration needed to clear high-grade AIN lesions, by quadrants of disease in the treatment arm. ; Timepoint(s): Over the course of the trial = 72 months
7. Proportion free of high-risk HPV types in the treatment arm, compared to the observation arm, at the end of the study. ; Timepoint(s): At end of trial = at 72 months
8. Incidence of anal cancer in the treatment arm compared to the observation arm stratified by HPV 16 detection. ; Timepoint(s): Over the course of the trial = 72 months
9. Health-related quality of life, as measured by Area Under the Curve for EQ-5D, in the treatment c compared to the observation arm at each visit post-randomisation. ; Timepoint(s): Over the course of the trial = 72 months
10. Health-related quality of life, as measured by Area Under the Curve for EQ-5D, in the treatment arm only, 1 month post-laser ablation; Timepoint(s): Over the course of the trial = 72 months
11. Total cost of each anal cancer case prevented (including equipment costs and clinic visits). ; Timepoint(s): Over the course of the trial = 72 months
12. A model of AIN grading, progression, regression and clearance as a result of laser ablative treatment. ; Timepoint(s): Over the course of the trial = 72 months
For all trial participants:
13. Anal cancer rates up to 40 years after enrolment in the screened, treated and surveillance patient groups (through a future ethically approved study). ; Timepoint(s): Up to 40 years after enrolment (as part of a future ethically-approved study)

Overall trial start date

01/10/2014

Overall trial end date

30/09/2021

Reason abandoned

Eligibility

Participant inclusion criteria

1. HIV ­ positive men who have sex with men (MSM) over 18 years of age (HIV status confirmed by patient’s HIV unit)
2. CD4 cell count of 350cells/µl or greater within twelve months of randomisation; if CD4 count is less than 350cells/µl the patient must be on highly active antiretroviral treatment for at least three months, confirmed by patient’s HIV unit
3. Not currently enrolled in any other intervention study about AIN or anal cancer
4. Willing to attend Homerton University Hospital NHS Foundation Trust for all treatment and follow up appointments if allocated to treatment arm of the study
5. Physical and mental capacity to give informed consent
6. Necessary level of verbal and/or reading comprehension of English to give informed consent

Only patients with histologically proven AIN2 and/or AIN 3 disease within the previous four months will be eligible for randomisation for the second part of the trial

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

Planned Sample Size: 3500; UK Sample Size: 3500; Description: We are screening about 3,500 participants. Those without high-grade anal precancer disease will not be asked to attend again. All participants found to have histology-proven high-grade precancer will be invited to continue into the second part of the trial. 660 participants with high-grade AIN disease from the 3,500 enrolled patients will be randomised 1:1 into the treatment and observation arms (N= 330 in each arm).

Participant exclusion criteria

1. Previous laser or other ablative treatment for AIN/warts in both the anal and perianal regions (cryotherapy if NOT an exclusion critera; if they previously had ablative treatment for external AIN disease/warts and now present with untreated anal canal disease they will be eligible; and similarly, if they had previous anal canal ablative treatment for AIN disease/warts and now present with untreated external disease, they will be eligible to participate in the trial)
2. Any other topical or surgical treatment for AIN 2 and/or AIN 3 or anal/perianal warts in the previous six months
3. Previous or current diagnosis of anal cancer or under investigation for anal cancer
4. Unable or unwilling to attend treatment and follow­up visits at the Homerton hospital (if randomised to treatment arm) or follow up visits at their recruiting site (if randomised to observation arm)

Recruitment start date

04/12/2015

Recruitment end date

02/01/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Homerton Hospital Anal Neoplasia Service (HANS)
Homerton University Hospital NHS Foundation Trust Clifden Centre Homerton Row
London
E9 6SR
United Kingdom

Trial participating centre

Bloomsbury Clinic, Mortimer Market Centre
London
WC1E 6JB
United Kingdom

Sponsor information

Organisation

Homerton Hospital Anal Neoplasia Service (HANS)

Sponsor details

Homerton University Hospital NHS Foundation Trust
Clifden Centre
Homerton Row
London
E9 6SR
United Kingdom
-
christine.inwang@homerton.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.homerton.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/11/2016: Internal review.