High Grade Anal Canal Squamous Intraepithelial NeoplasiaNCT02418494
Health-Related Symptom Questionnaires in Measuring Quality of Life in HIV-Infected Participants Treated or Monitored for Anal Lesions
An observational study of High Grade Anal Canal Squamous Intraepithelial Neoplasia and HIV Infection, run by AIDS Malignancy Consortium at 6 sites in United States.
Trial summary
This research trial studies health-related symptom questionnaires in measuring quality of life in human immunodeficiency virus (HIV)-infected participants treated with or monitored for anal lesions. Collecting information and symptoms from patients diagnosed with anal lesions may help reduce the risk of anal cancer. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- High Grade Anal Canal Squamous Intraepithelial Neoplasia, HIV Infection
- What is being tested?
- Concept Elicitation and Comprehension Assessment
- How many people
- 85 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2015to May 2016
- Phase
- Observational
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants diagnosed with HSIL within the prior 6 months enrolled at Weill Cornell Medical College/New York Presbyterian Hospital, Montefiore Medical Center, and Laser Surgery Care Center
Who may be able to join
- HIV-1 infection
- Biopsy-proven anal HSIL within the prior six months
- Life expectancy of greater than 5 years
Who cannot join
- History of anal cancer
- Inability to understand a written consent form
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Anal Dysplasia Clinic
Chicago, Illinois, 60614
Cornell Clinical Trials Unit
New York, New York, 10011
Laser Surgery Care
New York, New York, 10011
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
University of California at San Francisco - Comprehensive Cancer Center
San Francisco, California, 94143-0875
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
About this study
Official title: Development of a Health-Related Symptom Index for Persons Diagnosed With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions (HSIL)
This research trial studies health-related symptom questionnaires in measuring quality of life in human immunodeficiency virus (HIV)-infected participants treated with or monitored for anal lesions. Collecting information and symptoms from patients diagnosed with anal lesions may help reduce the risk of anal cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To develop an Anal Cancer/HSIL Outcomes Research Study (ANCHOR) high-grade squamous intraepithelial lesion (HSIL) health-related quality of life (HRQoL) Index (HQI) using state-of-the-art measure development methodology that captures the most important HRQoL symptoms and concerns of those persons diagnosed with anal HSIL and either treated or untreated for anal HSIL.
OUTLINE:
Participants complete the ANCHOR HSIL HRQoL interview over 45-60 minutes, comparing the list of symptoms, concerns, or HRQOL impacts related to HSIL diagnosis and treatment. Some patients also complete a cognitive interview for up to 3 sessions.
- Being tested
- Concept Elicitation, Comprehension Assessment
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concept ElicitationOther
Also called Cognitive Interview
Complete cognitive interview to elicit relevant HSIL symptoms, compare to study index of symptoms, and rank symptoms in relation to effect on health-related quality of life
Comprehension AssessmentOther
Also called Cognitive Interview
Comprehension assessment of draft quality of life assessment
| Study group | Role | What they receive |
|---|---|---|
| Observational (ANCHOR HRQoL interview, cognitive interview) | Participants complete the ANCHOR HSIL HRQoL interview over 45-60 minutes, comparing the list of symptoms, concerns, or HRQOL impacts related to HSIL diagnosis and treatment. Some patients also undergo a cognitive interview for up to 3 sessions. Receives: Other: Concept Elicitation; Other: Comprehension Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of an HQI using state-of-the-art measure development methodology that captures the most important HRQoL symptoms and concerns of those persons diagnosed with anal HSIL and either treated or untreated for anal HSIL.
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade Anal Canal Squamous Intraepithelial NeoplasiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIDS Malignancy Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), Memorial Sloan Kettering Cancer Center, Northwestern University, The Emmes Company, LLC, University of Arkansas
- Responsible party
- Sponsor
- Investigators
- Jack Burkhalter, Principal investigator, AIDS Associated Malignancies Clinical Trials Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418494
- Sponsor's protocol ID
- AMC-A02
- Other IDs
- NCI-2015-00160, AMC Protocol #A02, AMC-A02, AMC-A02, U01CA121947
- Status last verified
- Feb 2016
- First submitted
- 13 Apr 2015
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Health-Related Symptom Index for Persons Diagnosed With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions (HSIL)
- ClinicalTrials.gov ID
- NCT02418494
- Acronym / sponsor ID
- AMC-A02
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- AIDS Malignancy ConsortiumResearch network
- Collaborators
- National Cancer Institute (NCI), Memorial Sloan Kettering Cancer Center, Northwestern University, The Emmes Company, LLC, University of Arkansas
- Study start
- Apr 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 16 Apr 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.
This research trial studies health-related symptom questionnaires in measuring quality of life in human immunodeficiency virus (HIV)-infected participants treated with or monitored for anal lesions. Collecting information and symptoms from patients diagnosed with anal lesions may help reduce the risk of anal cancer.
Detailed description
PRIMARY OBJECTIVES:
- To develop an Anal Cancer/HSIL Outcomes Research Study (ANCHOR) high-grade squamous intraepithelial lesion (HSIL) health-related quality of life (HRQoL) Index (HQI) using state-of-the-art measure development methodology that captures the most important HRQoL symptoms and concerns of those persons diagnosed with anal HSIL and either treated or untreated for anal HSIL.
OUTLINE:
Participants complete the ANCHOR HSIL HRQoL interview over 45-60 minutes, comparing the list of symptoms, concerns, or HRQOL impacts related to HSIL diagnosis and treatment. Some patients also complete a cognitive interview for up to 3 sessions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (ANCHOR HRQoL interview, cognitive interview) | – | Other: Concept Elicitation, Other: Comprehension AssessmentParticipants complete the ANCHOR HSIL HRQoL interview over 45-60 minutes, comparing the list of symptoms, concerns, or HRQOL impacts related to HSIL diagnosis and treatment. Some patients also undergo a cognitive interview for up to 3 sessions. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants diagnosed with HSIL within the prior 6 months enrolled at Weill Cornell Medical College/New York Presbyterian Hospital, Montefiore Medical Center, and Laser Surgery Care Center
Key inclusion criteria (3 listed)
- HIV-1 infection
- Biopsy-proven anal HSIL within the prior six months
- Life expectancy of greater than 5 years
Key exclusion criteria (2 listed)
- History of anal cancer
- Inability to understand a written consent form
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 |
|---|---|---|
| Concept ElicitationAlso: Cognitive InterviewComplete cognitive interview to elicit relevant HSIL symptoms, compare to study index of symptoms, and rank symptoms in relation to effect on health-related quality of life | Other | Observational (ANCHOR HRQoL interview, cognitive interview) |
| Comprehension AssessmentAlso: Cognitive InterviewComprehension assessment of draft quality of life assessment | Other | Observational (ANCHOR HRQoL interview, cognitive interview) |
Primary outcome
Development of an HQI using state-of-the-art measure development methodology that captures the most important HRQoL symptoms and concerns of those persons diagnosed with anal HSIL and either treated or untreated for anal HSIL.
Time frame: Up to 4 months
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 9 Jun 2016.
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.
Jack Burkhalter principal investigator
AIDS Associated Malignancies Clinical Trials Consortium
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Grade Anal Canal Squamous Intraepithelial Neoplasia and HIV Infection, run by AIDS Malignancy Consortium at 6 sites in United States.
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 3 inclusion and 2 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 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
Development of an HQI using state-of-the-art measure development methodology that captures the most important HRQoL symptoms and concerns of those persons diagnosed with anal HSIL and either treated or untreated for anal HSIL. (time frame: Up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2016.