Идёт набор NCT06081517

Evaluating Disparities in Precision Oncology

— Наблюдательное Metastatic Cancer Advanced Cancer

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: Social Determinants of Health and toxicity questionnaires.
Кому может быть актуально: Состояния в реестре: Metastatic Cancer, Advanced Cancer. 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 →

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Официальное название

Evaluating Disparities in Precision Oncology: An Observational Trial in the Context of a Real-World Academic Practice Model

Обзор

This is a non-randomized observational trial designed to collect detailed clinical, social determinant, and genomic data from patients enrolled in molecular oncology tumor boards across four comprehensive cancer centers.

Подробное описание

This study proposes an innovative approach leveraging the molecular tumor boards across four comprehensive cancer centers, where real- world, diverse patients with metastatic cancer are seen receiving a broad scope of therapies in the context of precision medicine. The study plans to collect detailed clinical, social, and genomic data from patients to identify significant contributors of disparate survival and toxicity outcomes for patients with metastatic cancer.

Вмешательства

Поведенческое Social Determinants of Health and toxicity questionnaires
Collect detailed clinical, and social data from patients to identify significant contributors of disparate survival and toxicity outcomes.

Первичные конечные точки

Compare Overall Survival between Black patients and White patients (self-reported race) with advanced cancer [Срок оценки: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years]
Compare rate of new onset or worsening therapy- induced peripheral neuropathy (TIPN) between Black patients and White patients with advanced cancer prospectively exposed to a taxane [Срок оценки: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years]

Вторичные конечные точки (10)

Compare efficacy based on duration on therapy (DOT) between Black and White patients with advanced cancer (using self-reported race and percentage African ancestry) [Срок оценки: From baseline to end of treatment (i.e. up to 2 years)]
Assess the significance of key attributes (tumor genomics, clinical demographics, SDoH, access, and the intersection of tumor biology and drug impact) on efficacy, and survival outcomes [Срок оценки: Baseline]
Assess the significance of key attributes (clinical demographics, SDoH, host genomics and prior therapy exposures) on therapy-induced neuropathy [Срок оценки: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years]
Assess the impact of toxicity as measured by dose reductions or dose cessations attributed to TIPN from chart review measured as RDI, a function of the ratio of received to intended doses, and thus accounts for differences in drugs or time of therapy [Срок оценки: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years]
Evaluate for differences in the impact of neuropathy between Black and White cancer patients on change in patient-reported QoL [Срок оценки: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years]
Compare the rate of checkpoint inhibitor -induced immune -related adverse events (irAEs) between White and Black patients [Срок оценки: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years]
Compare the rate of cardiotoxic therapy -induced heart failure between White and Black patients [Срок оценки: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years]
Compare the rate of drug -induced hypertension between White and Black patients [Срок оценки: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years]
Compare utility of precision genomic information defined by the percentage of patients receiving results, screened for or enrolled on a genomically-directed clinical trial, and receiving a targeted therapy between White and Black patients [Срок оценки: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years]
Compare the differences in prevalence of level 1/2 actionable mutations, prior lines of therapy, receipt of a genomically matched therapy and receipt of an FDA-approved drug between Black and White patients [Срок оценки: through study completion (i.e. death, lost to follow up, or withdraw)-up to 5 years]

Критерии участия

Критерии включения

Ability to provide written informed consent and HIPAA authorization
Patients must be ≥ 18 years old at the time of consent
Patients who have or are planning to undergo molecular testing as part of their routine cancer care