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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00160 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| AMC Protocol #A02 | Other Identifier | AIDS Malignancy Clinical Trials Consortium | |
| AMC-A02 | Other Identifier | AIDS Malignancy Clinical Trials Consortium | |
| AMC-A02 | Other Identifier | CTEP | |
| U01CA121947 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Memorial Sloan Kettering Cancer Center | OTHER |
| Northwestern University | OTHER |
| The Emmes Company, LLC |
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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.
PRIMARY OBJECTIVES:
I. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concept Elicitation | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Jack Burkhalter | AIDS Associated Malignancies Clinical Trials Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at San Francisco - Comprehensive Cancer Center | San Francisco | California | 94143-0875 | United States | ||
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| INDUSTRY |
| University of Arkansas | OTHER |
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| Comprehension Assessment | Other | Comprehension assessment of draft quality of life assessment |
|
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| Anal Dysplasia Clinic |
| Chicago |
| Illinois |
| 60614 |
| United States |
| Cornell Clinical Trials Unit | New York | New York | 10011 | United States |
| Laser Surgery Care | New York | New York | 10011 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Montefiore Medical Center-Einstein Campus | The Bronx | New York | 10461 | United States |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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