Использование инструмента скрининга для описания бремени рака, связанного с ВИЧ, и характеристик пациентов в AMC
Использование инструмента скрининга для описания бремени рака, связанного с ВИЧ, и характеристик пациентов в консорциуме по изучению злокачественных новообразований СПИДа Испытание Консорциума по злокачественным новообразованиям при СПИДе (AMC)
This study is being done to understand how many people with HIV (PWH) present for cancer care across the AIDS Malignancy Consortium in the United States and if there are reasons that some PWH choose to participate, or not in cancer clinical trials. Optional quality of life surveys will be used to learn more about how HIV and cancer and HIV and cancer treatment affect people.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Primary Objective: To estimate the number of cancers in people with HIV (PWH) who present for care at domestic AMC sites
Secondary Objectives: To characterize participants that are eligible but not enrolled onto AMC clinical trials to understand site-specific and trial-specific accrual barriers
Exploratory Objectives: 1. To standardize and expand the quantity and quality of sociodemographic and cancer diagnostic and treatment characteristics collected for PWH receiving care at domestic AMC sites. 2. To describe cancer patient health-related QOL for PWH at domestic AMC sites using validated tools: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30] and Supportive Care Needs Survey Short Form 34 [SCNS-SF34]
Outline: Participants identified via screening of electronic medical records or institutional databases. All eligible participants attend one visit for the collection of broad demographic and clinical data. Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit. Data collection at study visits will occur via survey procedures and/or medical record review.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
-
-
-
San Juan, Пуэрто-Рико, 00921
- University of Puerto Rico
-
-
-
-
California
-
La Jolla, California, Соединенные Штаты, 92903
- Moores UCSD Cancer Center
-
-
District of Columbia
-
Washington D.C., District of Columbia, Соединенные Штаты, 20037
- George Washington University Cancer Center
-
-
Florida
-
Miami, Florida, Соединенные Штаты, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
-
Tampa, Florida, Соединенные Штаты, 33612
- Moffitt Cancer Center
-
-
Illinois
-
Chicago, Illinois, Соединенные Штаты, 60612
- University of Illinois at Chicago
-
-
Maryland
-
Baltimore, Maryland, Соединенные Штаты, 21231
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
-
Missouri
-
St Louis, Missouri, Соединенные Штаты, 63110
- Washington University School of Medicine
-
-
New York
-
New York, New York, Соединенные Штаты, 10029
- Mount Sinai Hospital
-
New York, New York, Соединенные Штаты, 10010
- Weill Cornell Medicine - Cornell Clinical Trials Unit
-
The Bronx, New York, Соединенные Штаты, 10467
- Montefiore Medical Center
-
-
Ohio
-
Columbus, Ohio, Соединенные Штаты, 43210
- The Ohio State University
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Соединенные Штаты, 19106
- Abramson Cancer Center at Pennsylvania Hospital
-
-
Texas
-
Houston, Texas, Соединенные Штаты, 77030
- MD Anderson Cancer Center
-
-
Utah
-
Salt Lake City, Utah, Соединенные Штаты, 84112
- Huntsman Cancer Institute - University of Utah
-
-
Washington
-
Seattle, Washington, Соединенные Штаты, 98101
- Virginia Mason Medical Center
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Participants with a dual diagnosis of both cancer (current or diagnosed within 5 years) and underlying HIV infection, who present for care at AMC domestic sites.
Описание
Inclusion Criteria:
-
Participant can understand and is willing to sign a written informed consent document.
-
HIV positive. Documentation of HIV-1 infection by means of any one of the following:
- Documentation of an HIV diagnosis in the medical record by a licensed health care provider;
- Documentation of receipt of antiretroviral therapy (ART) (i.e., at least two different medications that do not constitute a prescription for pre-exposure prophylaxis [PrEP]) by a licensed health care provider. Documentation may be a record of an ART prescription in the medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name;
- HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating >1000 RNA copies/mL;
- Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay.
Note: The term "licensed" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally (e.g., U.S. FDA).
WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay, or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), a Western blot, or a plasma HIV-1 RNA viral load.
-
Patient was diagnosed with or treated for cancer within the last 5 years. Participants will qualify under one of three categories:
- New, primary or recurrent diagnosis -Considering or currently receiving cancer treatment
- Metastatic or locally advanced cancer - This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
- Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
-
Age ≥ 18 years.
-
Participant presents to an AMC domestic clinical trial site for either clinical care or research.
Exclusion Criteria:
- Participants who do not fulfill the criteria as listed above are ineligible.
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: PROSPECTIVE
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
New, primary or recurrent disease
Considering or currently receiving cancer treatment |
Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review. Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review. |
|
Metastic or locally advanced cancer
This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies. |
Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review. Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review. |
|
Prior cancer
Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy. |
Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Number of Cancers in People With HIV (PWH) Who Present for Care at Domestic AMC Sites
Временное ограничение: Enrollment
|
For each cancer group listed below, the number of new and existing cases per month will be estimated. The distribution of cancer types will be computed as percentages and compared to the cancer type distribution in the HIV/AIDS Cancer Match (HACM) Study:
|
Enrollment
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percentage of Participants Eligible for AMC Trials Who Are Successfully Enrolled
Временное ограничение: Baseline
|
This will be calculated by the number of participants enrolled who meet site-based AMC trial eligibility compared to the number of eligible participants at each site who meet site-based AMC trial eligibility. |
Baseline
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Describe the Cancer Diagnostics of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
Временное ограничение: Baseline
|
The distribution of participant cancer diagnosis variable will be summarized. |
Baseline
|
|
Describe the Gender Distribution of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
Временное ограничение: Baseline
|
The distribution of participant gender variable will be summarized. |
Baseline
|
|
Describe the Age Distribution of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
Временное ограничение: Baseline and 12 weeks
|
The distribution of participant characteristics will be summarized. Continuous variables [e.g. age, height, weight] will be summarized as mean (std) if they are normally distributed, otherwise they will be summarized as median (IQR). Categorical variables [e.g. tobacco use, ART medications, comorbidities] will be summarized as frequency (%). |
Baseline and 12 weeks
|
|
Describe the Treatment Characteristics of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
Временное ограничение: Baseline
|
The distribution of participant cancer treatment at enrollment will be summarized. |
Baseline
|
|
Planned Cancer Therapy for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment
Временное ограничение: 12 weeks
|
The frequency of planned cancer treatment regimens (at baseline) successfully initiated will be summarized. |
12 weeks
|
|
Describe the Health-related QOL of Cancer Patients With HIV at Domestic AMC Sites Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]
Временное ограничение: Baseline
|
EORTC QLQ-C30 subscale and overall scores will be used to describe participant symptom and health-related quality of life burden. Baseline EORTC QLQ-C30 scores will be compared according to cancer group. The EORTC QLQ-C30 is a 30-item core cancer specific questionnaire measuring QOL in cancer patients. It incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and single items assessing additional symptoms and perceived financial impact of the disease. Most questions use a 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions use a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=higher response level. |
Baseline
|
|
Describe the Supportive Care Needs of Cancer Patients With HIV at Domestic AMC Sites Using Supportive Care Needs Survey Short Form 34 [SCNS-SF34]
Временное ограничение: Baseline
|
Supportive Care Needs Survey Short Form 34 [SCNS-SF34] scores will be used to categorize participants based on the degree to which their needs are met. Baseline SCNS-SF34 scores will be compared according to cancer group. The SCNS-SF34 is a 34-item questionnaire measuring the supportive care need and level of need for people diagnosed with cancer in the last month. It incorporates the underlying domains: physical and daily living, psychological, sexuality and health system, information and patient support. All the questions use 5-point scale (1 'Not applicable' to 5 'High need); with a higher score indicating a higher level of need. |
Baseline
|
|
Change of Quality of Life at 12 Weeks From Baseline for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]
Временное ограничение: Baseline and 12 weeks
|
EORTC QLQ-C30 will be summarized, both overall and at the ~12-week follow-up, according to participant characteristics and cancer groups. Overall change in QOL will be compared with paired tests and change according to groups will be compared using t-tests, ANOVA, or nonparametric tests. The EORTC QLQ-C30 is a 30-item core cancer specific questionnaire measuring QOL in cancer patients. It incorporates five functional scales (physical, role,cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms and perceived financial impact of the disease. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=higher response level. |
Baseline and 12 weeks
|
|
Change of Needs From Baseline for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment Using Supportive Care Needs Short Survey Form 34 [SCNS-SF34]
Временное ограничение: Baseline and 12 weeks
|
Supportive Care Needs Short Survey Form 34 [SCNS-SF34] scores will be summarized, both overall and at the ~12-week follow-up, according to participant characteristics and cancer groups. Overall change in scores will be compared with paired tests and change according to groups will be compared using t-tests, ANOVA, or nonparametric tests. The SCNS-SF34 is a 34-item questionnaire measuring the supportive care need and level of need for people diagnosed with cancer in the last month. It incorporates the underlying domains: physical and daily living, psychological, sexuality and health system, information and patient support. All the questions use 5-point scale (1 'Not applicable' to 5 'High need). Scores are averaged, and transformed to 0-100 scale;, with a higher score indicating a higher level of need. |
Baseline and 12 weeks
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Учебный стул: Anna E Coghill, PhD, MPH, AIDS Malignancy Consortium
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Инфекции, передающиеся через кровь
- Урогенитальные заболевания
- Генитальные заболевания
- Урогенитальные новообразования
- Новообразования по локализации
- Женские урогенитальные заболевания
- Женские мочеполовые заболевания и осложнения беременности
- Кишечные заболевания
- Заболевания иммунной системы
- Инфекции
- РНК-вирусные инфекции
- Вирусные заболевания
- Новообразования по гистологическому типу
- Желудочно-кишечные новообразования
- Новообразования пищеварительной системы
- Заболевания пищеварительной системы
- Желудочно-кишечные заболевания
- Колоректальные новообразования
- Новообразования кишечника
- Заболевания прямой кишки
- Заболевания матки
- Заболевания половых органов, Женский
- Передающиеся заболевания
- Заболевания, передающиеся половым путем, вирусные
- Заболевания, передающиеся половым путем
- Лентивирусные инфекции
- Ретровирусные инфекции
- Синдромы иммунологического дефицита
- ДНК-вирусные инфекции
- Генитальные Новообразования, Женщины
- Лимфатические заболевания
- Лимфопролиферативные заболевания
- Иммунопролиферативные заболевания
- Лимфома, неходжкинская
- Медленные вирусные заболевания
- Заболевания шейки матки
- Лимфома, В-клеточная
- Новообразования матки
- Саркома
- Новообразования соединительной и мягкой ткани
- Герпесвирусные инфекции
- Новообразования, сосудистая ткань
- Заболевания ануса
- Новообразования прямой кишки
- Гемики и лимфатические заболевания
- Новообразования
- ВИЧ-инфекции
- Лимфома
- Синдром приобретенного иммунодефицита
- Новообразования шейки матки
- Саркома Капоши
- Новообразования ануса
- Лимфома, связанная со СПИДом
- Саркома Капоши, связанная со СПИДом
Другие идентификационные номера исследования
- AMC-115
- UM1CA121947 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .