Меню
Идёт набор NCT03937453

A Pancreatic Cancer Screening Study in Individuals With New-Onset or Deteriorating Diabetes Mellitus

— Наблюдательное Pancreatic Cancer Pancreatic Neoplasms Diabetes Mellitus

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: MRI/MRCP.
Кому может быть актуально
Состояния в реестре: Pancreatic Cancer, Pancreatic Neoplasms, Diabetes Mellitus. Базовые параметры: от 50 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A PAncreatic Cancer Screening Study in Individuals With New-Onset or DeteriOrating Diabetes MEllitus (PANDOME Study)

Обзор

The main goal of this study is to explore the relationship between new-onset diabetes mellitus/deteriorating diabetes and a subsequent diagnosis of pancreatic cancer. Magnetic Resonance Imaging and Magnetic cholangiopancreatography (MRI/MRCP) will be utilized to screen for early stage pancreatic cancer or precursor lesions. Participants will be asked to donate a blood sample at specific intervals for the creation of a bio-bank necessary for the development of a blood based screening test for pancreatic cancer.

Подробное описание

Individuals over 50 years of age who have developed new-onset diabetes mellitus (diagnosed within the past 12 months) or deteriorating diabetes will be recruited through the offices of primary care physicians and endocrinologists. Those meeting initial criteria will meet with a research APRN and will undergo a secondary screen to determine eligibility. Individuals enrolled in the study will undergo a five-minute psychological survey and donation of a blood sample for bio-bank analysis every 6 months for 3 years. MRI will be performed at baseline. Any abnormalities on MRI will be reviewed by a multi-disciplinary tumor board and discussed with the participant. Additional MRI will be performed on case-by-case basis

Вмешательства

  • Диагностический тест MRI/MRCP
    An MRI/MRCP with IV gadolinium contrast with high resolution imaging of the pancreas will be performed at baseline. Further imaging upon recommendation by study committee

Первичные конечные точки

  • Early Stage Pancreatic Cancer or Precursor Lesions [Срок оценки: Through study completion, up to 3 years]
Вторичные конечные точки (2)
  • Relative Risk of Pancreatic Cancer Among Individuals with New-Onset Diabetes [Срок оценки: Through study completion, up to 3 years]
  • Relative Risk of Pancreatic Cancer Among Individuals with Detiorating diabetes [Срок оценки: Through study completion, up to 3 years]

Критерии участия

Критерии включения

  • Age of at least 50 years.
  • DM of Confirmed Duration: DM diagnosed within the past 12 months AND documentation of prior normal FPG, OGTT or HbA1c levels within the past 2 years. Requirement for HbA1c ≥ 6.5% OR
  • DM of Unconfirmed Duration: DM diagnosed within the past 12 months BUT no prior record of normal FPG, HbA1c or OGTT within the past 2 years. Requirement for HbA1c ≥ 7.0% OR
  • Transition from pre-Diabetes to Diabetes Mellitus within the past 12 months characterized by a change in the HbA1c of ≥ 0.5% OR
  • DM With Only One FDR: DM diagnosed within the past 12 months that is of Confirmed or Unconfirmed Duration, in an individual with 1 FDR. Requirement for HbA1c ≥ 6.5%. OR
  • Deteriorating Diabetes: DM with >2% spike in HbA1c within past 6 months confirmed with repeat testing and NOT associated with weight gain and diabetes medication non-compliance
  • ECOG Performance Status of 0-1.
  • No known contraindications to MRI examination or gadolinium contrast.
  • Willing to undergo MRI and screening for metal implants or metal injury.
  • Ability to provide informed consent.
  • Willing to return to study site for all study assessments.

Критерии исключения

  • Prior history of pancreatic cancer.
  • Presence of metastatic cancer or cancer requiring adjuvant chemotherapy within the past 5 years.
  • Received chemotherapy within the past 6 months. (Hormonal therapy is allowable if the disease free interval is at least 5 years).
  • Hereditary pancreatitis.
  • Use of high dose glucocorticoid steroids (at least 20 mg daily of prednisone) within 3 months of diabetes diagnosis or elevation of HbA1c. Lower doses of steroid use as a cause of glucocorticoid-induced diabetes will be made on a case-by-case basis.
  • Contraindication to MRI examination or gadolinium contrast.
  • Pregnant or nursing women.
  • Co-morbid illnesses or other concurrent disease which, in the judgment of the clinicians obtaining informed consent, would make the participant inappropriate for entry into 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 · 2 центра
  • Yale University — New Haven
  • Nuvance Health — Norwalk

Идентификаторы

NCT: NCT03937453 · 18-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗