Targeted Genomic Analysis of Blood and Tissue Samples From Patients With 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: Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis.
- Кому может быть актуально
- Состояния в реестре: Malignant Neoplasm. Базовые параметры: от 1 год · 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
Targeted Genomic Analysis of Human Cancers
Обзор
This research trial studies the use of targeted genomic analysis of blood and tissue samples from patients with cancer. Genomic sequencing is a laboratory method that is used to determine the entire genetic makeup of a specific organism or cell type. Genomic sequencing can be used to find changes in areas of the genome that may be important in the development of cancer. It may also help doctors improve ways to diagnose and treat patients with rare cancers with poor prognosis or lack of effective therapy.
Подробное описание
PRIMARY OBJECTIVES:
I. To obtain blood and tumor tissue for next-generation sequencing and determine the frequency of finding genomic alterations for which there are clinically available (commercially or research based) targeted therapies. Treating clinicians will be provided with relevant validated mutation data for treatment or referral of the patient to pertinent studies.
II. To collect clinical outcomes of patients with actionable mutations for which sequencing has been performed.
III. To obtain tumor genome data for data storage and future computational analysis and correlation with clinical data.
IV. To obtain tumor tissue for development of future in vitro and in vivo cancer models.
OUTLINE:
Previously collected tissue samples are analyzed for the presence of mutations via next generation sequencing. Patients may also undergo collection of blood samples for analysis of circulating cell-free deoxyribonucleic acid (DNA) and circulating tumor cells.
After completion of study, patients are followed up every 3 months for 2 years and then every 6 months for 15 years.
Вмешательства
- Другое Cytology Specimen Collection Procedure
Undergo collection of blood samples - Другое Laboratory Biomarker Analysis
Correlative studies
Первичные конечные точки
- Frequencies of individual specific mutations and combinations of mutations of related pathway genes [Срок оценки: Up to 15 years]
- Rate of actionable mutations in rare and/or poor prognosis cancers [Срок оценки: Up to 15 years]
Критерии участия
Критерии включения
- Karnofsky/Lansky performance score >= 30
- A signed written informed consent
- Evaluation in surgical/medical/radiation oncology/radiology clinic, with a history of biopsy-confirmed diagnosis of cancer of rare histology and/or poor prognosis with standard therapy; priority will be given to rare cancers with poor prognosis and lack of effective standard therapy; study principal investigator (PI) or designee will review and approve each case before enrollment
- Paraffin blocks of the patient's tumor tissue are available and accessible for analysis
Критерии исключения
- Karnofsky/Lansky performance score < 30
- Life expectancy < 3 months
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 11 центров
- Ocean Medical Center — Brick
- Bayshore Community Hospital — Holmdel
- RWJBarnabas Health - Jersey City Medical Center, Jersey City — Jersey City
- Southern Ocean County Medical Center — Manahawkin
- Morristown Medical Center — Morristown
- Jersey Shore Medical Center — Neptune City
- Rutgers Cancer Institute of New Jersey — New Brunswick
- Riverview Medical Center/Booker Cancer Center — Red Bank
- … и ещё 3 центра
Публикации
- Blaszczyk MB, Boukhar SA, Zhou Z, Berim L, Ganesan S, Riedlinger GM. Occult collision tumor of the gastroesophageal junction comprising adenocarcinomas with distinct molecular profiles. Cancer Genet. 2025 Apr;292-293:27-34. doi: 10.1016/j.cancergen.2025.01.001. Epub 2025 Jan 4. PMID 39805155
Идентификаторы
NCT: NCT02688517 · Pro2012002075 · NCI-2015-01812 · CINJ # 001209 · 001209 · P30CA072720 · Pro2012002075