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Идёт набор NCT03334708

A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma

— Наблюдательное Pancreatic Cancer Pancreatic Diseases Pancreatitis Pancreatic Cyst

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: Blood Draw, Tumor Tissue Collection, Cyst Fluid.
Кому может быть актуально
Состояния в реестре: Pancreatic Cancer, Pancreatic Diseases, Pancreatitis, Pancreatic Cyst. 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, Израиль
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

Development of Biomarkers for the Early Detection, Surveillance and Monitoring of Pancreatic Ductal Adenocarcinoma

Обзор

The purpose of this study is to develop a minimally invasive test to diagnose pancreatic cancer at early stages of disease and monitor response to treatment.

Вмешательства

  • Диагностический тест Blood Draw
    If clinically safe, up to approximately 50ml of blood will be drawn, not to exceed the following criteria: Patients and controls weighing 50kg or more * For draw amounts up to 50mL, there is no required hemoglobin threshold. * For amounts exceeding 50mL, patients who meet standard blood banking criteria (e.g., hemoglobin values within normal limits and minimum weight of 50kg) may give as much as a full unit of blood (500mL) at one time or in divided fractions over a 56 day/eight week period.
  • Диагностический тест Tumor Tissue Collection
    Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
  • Диагностический тест Cyst Fluid
    Cyst fluid will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere

Первичные конечные точки

  • Change in biomarkers to determine sensitivity and specificity of the assay to diagnose early stage pancreatic cancer [Срок оценки: 4 years]

Критерии участия

Критерии включения

Cohort 1: Advanced Pancreatic Cancer Cohort Inclusion Criteria

  • Radiological, histological or cytological confirmed diagnosis of locally advanced or metastatic pancreatic adenocarcinoma by the enrolling institution
  • Patient planning to receive systemic treatment
  • Hemoglobin > 8
  • ECOG performance status 0-2
  • A minimum age of 18 years old
  • Willing to undergo a tumor biopsy
  • Willing to provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material).

Cohort 2: Operable Pancreatic Cancer Cohort Inclusion Criteria

  • Radiological, histological or cytological confirmed diagnosis of pancreatic adenocarcinoma by the enrolling institution
  • Patient planned to undergo upfront resection
  • No pre-operative systemic therapy nor chemoradiation therapy planned
  • Hemoglobin > 8
  • ECOG performance status 0-2
  • A minimum age of 18 years old
  • Willing to undergo a tumor biopsy
  • Willing to provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material).

Cohort 3: Acute Benign Pancreatic Pathology Control Inclusion Criteria

  • Confirmed diagnosis of acute pancreatitis or other acute pancreatic pathology by the enrolling institution
  • Hemoglobin > 8
  • ECOG performance status 0-2
  • A minimum age of 18 years old

Cohort 4: Chronic Benign Pancreatic Pathology Control Inclusion Criteria

  • Confirmed diagnosis of chronic pancreatitis or other non-cystic chronic pancreatic pathology by the enrolling institution
  • Hemoglobin > 8
  • ECOG performance status 0-2
  • A minimum age of 18 years old

Cohort 5: IPMN Control Inclusion Criteria

  • Confirmed diagnosis of IPMN without high risk features by the enrolling institution
  • A minimum age of 18 years old

Cohort 6: Pancreatic Cyst Control Inclusion Criteria

  • Confirmed diagnosis of benign pancreatic cyst by the enrolling institution
  • A minimum age of 18 years old

Cohort 7: Healthy Control Inclusion Criteria

  • A minimum age of 18 years old

Критерии исключения

Cohort 1: Advanced Pancreatic Cancer Cohort Exclusion Criteria

  • Prior chemotherapy or radiation therapy for pancreatic cancer within the last 3 months in the localized setting
  • Active second malignancy, unless low grade malignancy
  • Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures

Cohort 2: Operable Pancreatic Cancer Cohort Exclusion Criteria

  • Neoadjuvant chemotherapy or radiation therapy is planned
  • Active second malignancy, unless low grade malignancy
  • Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures

Cohort 3: Acute Benign Pancreatic Pathology Control Exclusion Criteria

  • Active or prior malignancy, except prior non-melanoma skin cancer
  • Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
  • Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures

Cohort 4: Chronic Benign Pancreatic Pathology Control Exclusion Criteria

  • Active or prior malignancy, except prior non-melanoma skin cancer
  • Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
  • Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures

Cohort 5: IPMN Control Exclusion Criteria

  • IPMN with high risk features or planned resection
  • Active or prior malignancy, except prior non-melanoma skin cancer
  • Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
  • Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures

Cohort 6: Pancreatic Cyst Control Exclusion Criteria

  • Active or prior malignancy, except prior non-melanoma skin cancer
  • Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
  • Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures

Cohort 7: Healthy Control Exclusion Criteria

  • Active or prior malignancy, except prior non-melanoma skin cancer
  • Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
  • Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures

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 · 10 центров
  • Memorial Sloan Kettering Monmouth (All protocol activities) — Middletown
  • Memorial Sloan Kettering Bergen (All protocol activities) — Montvale
  • Cold Springs Harbor Laboratory (Specimen Analysis) — Cold Spring Harbor
  • Memorial Sloan Kettering Cancer Center @ Commack (All Protocol Activities) — Commack
  • Memorial Sloan Kettering Westchester (All protocol activities) — Harrison
  • New York University — New York
  • Memorial Sloan - Kettering Cancer Center — New York
  • Memorial Sloan Kettering Basking Ridge (All protocol activities) — New York
  • … и ещё 2 центра
Израиль · 3 центра
  • Sha'are Zedek Medical Center — Jerusalem
  • Weizmann Institute of Science — Rehovot
  • Sheba Medical Center — Tel Litwinsky

Идентификаторы

NCT: NCT03334708 · 17-527

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗