Beat Childhood Cancer Specimen Banking and Data Registry

Официальное название

Specimen Banking With Clinical and Genomic Data Registry With the Establishment of Tumor Models for Pediatric Cancers

Обзор

This is an observational data registry study of pediatric cancer patients at participating Beat Childhood Cancer Consortium sites involving specimen banking and data collection.

Подробное описание

This observational registry and banking study is being performed on a large cohort of subjects who have received molecular testing to better understand the relationship between genomic and molecular information and clinical outcomes, and to enable timely and informed treatment decisions by physicians for their cancers. We hypothesize that large gene panels, sequencing (DNA/RNA), and epigenetics of tumors can identify molecular aberrations that can be leveraged to offer more effective treatment. Findings may highlight additional areas of research required to better understand the molecular underpinnings of the relationship between molecular abnormalities and disease. Banked specimens and the creation of tumor cell lines and xenograft models will facilitate further advancement of this research.

Вмешательства

• Другое No intervention- registry only
  No intervention- registry only

Первичные конечные точки

• Create a data registry of clinical and molecular/genomic data [Срок оценки: 10 Years]
• Determine number and types of genomic alterations within tumor types/subtypes [Срок оценки: 10 Years]
• Evaluate the rate of actionable genomic alternations [Срок оценки: 10 Years]
• Evaluate the correlation of baseline genomic alterations with clinical outcome. [Срок оценки: 10 Years]
• Identify biomarkers that predict risk of adverse outcomes that occur following pediatric cancer therapy. [Срок оценки: 10 Years]

Вторичные конечные точки (4)

• Bank additional specimens available for future research projects [Срок оценки: 10 Years]
• Develop cell line and xenograft models of pediatric cancers for future research [Срок оценки: 10 Years]
• Identify biomarkers that predict risks of disease states in subject controls that did not receive cancer therapy. [Срок оценки: 10 Years]
• Identify biomarkers that may predict risk of disease dependent on sex, race, ethnicity, or the presence of comorbidities. [Срок оценки: 10 Years]

Критерии участия

Критерии включения

• No age restrictions
• Subjects that fit into one of the following categories:

• Subjects with suspected or confirmed cancers of childhood, adolescence, or young adulthood.
• Survivors of a cancer of childhood, adolescence, or young adulthood (> 6 months off last therapy for cancer)
• Subjects with a disease-matched condition
• Healthy volunteers- including any participants with medical conditions that are not disease-matched.
• Written informed consent in accordance with institutional and FDA guidelines must be obtained from all subjects (or subjects' legal representative).

Критерии исключения

• Subject or his/her legally authorized representative (where applicable) did not consent for specimen banking and data collection for this study.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 18 центров

• Arkansas Children's Hospital — Little Rock
• Rady Children's Hospital — San Diego
• Connecticut Children's Hospital — Hartford
• Nicklaus Children's Miami — Miami
• Arnold Palmer Hospital for Children — Orlando
• St. Joseph's Children's Hospital — Tampa
• University of Iowa — Iowa City
• Norton Children's Research Institute/Affiliated with University of Louisville School of Me — Louisville
• … и ещё 10 центров

Идентификаторы

NCT: NCT04715178 · BCC-BIO-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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