Меню
Идёт набор NCT05663502

Collecting Blood and Tissue Sample Donations for Research for HIV/AIDS-Related Cancers

— Наблюдательное Anal Carcinoma Hematopoietic and Lymphoid Cell Neoplasm HIV Infection Kaposi Sarcoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Biospecimen Collection.
Кому может быть актуально
Состояния в реестре: Anal Carcinoma, Hematopoietic and Lymphoid Cell Neoplasm, HIV Infection, Kaposi Sarcoma. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Biospecimen Collection and Donation to the AIDS and Cancer Specimen Resource (ACSR): A Companion Protocol to AMC Trials

Обзор

This study collects blood and tissue samples for research of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS)-related cancers. Collecting blood and tissue samples and studying biomarkers in the laboratory may help doctors to learn how are biologic or genetic factors related to HIV and cancers that occur commonly in people living with HIV.

Подробное описание

This study is collecting blood and tissue samples (biospecimens) from people living with HIV, who are participating in an AIDS Malignancy Consortium (AMC) clinical trial. Biospecimens are also collected from people who are not living with HIV, but who have a type of cancer that is common in persons living with HIV. The National Cancer Institute created the AIDS and Cancer Specimen Resource (ACSR), a place where these tissue samples are stored, so researchers can learn more about how to treat HIV and related diseases. The AMC works with the AIDS and Cancer Specimen Resource (ACSR) to collect donated samples from people living with HIV or who have cancers that are associated with HIV for future research studies. People who do not take part in an AMC clinical trial can donate samples to the ACSR.

Individuals who agree to participate will be asked to donate blood once. Their blood will be stored in a biobank, and used for research. Individuals may also donate tissue - either from a previous procedure, or from an upcoming procedure.

Вмешательства

  • Процедура Biospecimen Collection
    Undergo blood and/or tumor tissue sample collection

Первичные конечные точки

  • Number of biospecimens collected [Срок оценки: Through study completion, anticipated to be 10 years]

Критерии участия

Критерии включения

  • Participants must be at least 18 years of age
  • Participant must be HIV- positive and have a diagnosed malignancy. If participants are HIV-negative, they must have a newly diagnosed or recurrent malignancy that has an established scientific connection (e.g., shared etiology) to an AIDS- associated malignancy such as:
  • classic Kaposi sarcoma
  • transplant-associated Kaposi sarcoma,
  • anal cancer,
  • multicentric Castleman's disease,
  • Epstein Barr Virus (EBV) -positive lymphoma
  • plasmablastic lymphoma
  • Hodgkin's lymphoma.
  • For participants that are HIV-positive, HIV infection must be documented by means of any one of the following: :
  • Documentation of HIV diagnosis in the medical record by a licensed health care provider;
  • Documentation of receipt of antiretroviral therapy (ART) by a licensed health care provider (Documentation may be a record of an ART prescription in the participant's 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. Receipt of at least two agents is required; each component agent of a multi-class combination ART regimen will be counted toward the 2-agent requirement, excepting receipt of a pre-exposure prophylaxis (PrEP) regimen alone \[e.g., Truvada\], which is exclusionary);
  • HIV ribonucleic acid (RNA) detection by a licensed HIV 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 Western blot confirmation or HIV rapid multispot antibody differentiation assay.
  • Participants with HIV infection, regardless of participation in an AMC clinical trial, must have a diagnosis of cancer, cancer or a condition that places them at a higher risk of cancer.
  • The investigator determines that the participant (or his/her legally authorized representative \[LAR\]) has the ability to provide informed consent and the participant or LAR provides written informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

США · 8 центров
  • UC San Diego Moores Cancer Center — La Jolla
  • University of California, San Francisco — San Francisco
  • George Washington University — Washington D.C.
  • University of Miami — Miami
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore
  • Mount Sinai Hospital — New York
  • Memorial Sloan Kettering Cancer Center — New York
  • Huntsman Cancer Institute, University of Utah — Salt Lake City

Идентификаторы

NCT: NCT05663502 · AMC-S005 · NCI-2021-05722 · AMC-S005 · AMC-S005 · UM1CA121947

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗