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Идёт набор NCT01050504

Collecting and Studying Blood and Tissue Samples From Patients With Locally Recurrent or Metastatic Prostate or Bladder/Urothelial Cancer

— Наблюдательное Localized Renal Pelvis and Ureter Urothelial Carcinoma Malignant Solid Neoplasm Metastatic Malignant Neoplasm in the Bone Metastatic Malignant Neoplasm in the Soft Tissues

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: Localized Renal Pelvis and Ureter Urothelial Carcinoma, Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Neoplasm in the Soft Tissues. Базовые параметры: от 18 лет · Мужчины.
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

Molecular Correlates of Sensitivity and Resistance to Therapy in Genitourinary Malignancy

Обзор

This study collects and studies tissue and blood samples from patients with prostate or bladder/urothelial cancer that has recurred (come back) at or near the same place as the original (primary) tumor or has spread to other parts of the body. Studying samples of blood and tissue samples from patients with prostate or bladder/urothelial cancer in the laboratory may help doctors learn more about new biomarkers, potential drug targets, and resistance developing in response to treatment. It may also help doctors find better ways to treat the cancer.

Подробное описание

OUTLINE:

Patients undergo collection of blood and tissue samples for analysis via mutation mapping, DNA sequencing, gene expression microarray, and gene profiling.

Вмешательства

  • Другое Cytology Specimen Collection Procedure
    Correlative studies
  • Другое Laboratory Biomarker Analysis
    Correlative studies

Первичные конечные точки

  • DNA genomic sequencing [Срок оценки: Up to 6 years]
  • Gene expression profile using microarray assays [Срок оценки: Up to 6 years]
  • Mutation mapping using the OncoMap and other genotyping techniques [Срок оценки: Up to 6 years]
Вторичные конечные точки (2)
  • Expression of androgen metabolic enzymes by quantitative real time-polymerase chain reaction [Срок оценки: Up to 6 years]
  • Proteomic profile [Срок оценки: Up to 6 years]

Критерии участия

Критерии включения

  • Patients with localized and/or metastatic bladder/urothelial or prostate cancer who have disease in the primary organ, biopsy accessible bone metastases (collaborating radiologists will determine if bone metastasis is appropriate for biopsy) or soft tissue metastases are eligible; men and women without cancer are eligible to have blood or normal tissue collected if acquired as part of non-research procedures (e.g. transurethral resection of the prostate or bladder); in patients without malignancy, no additional tissue beyond that necessary for care will be procured
  • Ability to adequately understand and give informed consent
  • Local or metastatic disease to soft tissue or bone at sites accessible to biopsy with minimal risk of complications Or the ability to obtain tissue with minimal risk of complication from a surgical procedure being conducted as a part of another research study Or for standard of care purposes or patients who have archival tissue collected for research or standard of care who are willing to donate archival tissue for this study
  • Alternatively, men and women without cancer or who are at risk of developing cancer are eligible to have blood or normal tissue collected if acquired; tissue will only be acquired as part of non-research procedures (e.g. transurethral resection of the prostate or bladder; in patients without malignancy, no additional tissue beyond that necessary for care will be procured
  • Platelet count > 50,000
  • White blood cell (WBC) > 1,500
  • Hemoglobin (Hgb) > 8.0
  • International normalized ratio (INR) < 1.5
  • Partial thromboplastin time (PTT) < 45
  • No history of excessive unexplained bleeding from previous surgery

Критерии исключения

  • Patients unable to stop chronic anticoagulation with warfarin or Lovenox for less than 3 days
  • Serious or uncontrolled infection
  • Treatment with a vascular endothelial growth factor (VEGF) inhibitor (such as Avastin) within the past 28 days

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 1 центр
  • Fred Hutch/University of Washington Cancer Consortium — Seattle

Идентификаторы

NCT: NCT01050504 · 6932 · NCI-2014-01087 · 6932p · 6932 · RG1712006 · P50CA097186

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗