Идёт набор NCT05058846

Pilot Study of Pancreatic Cancer Screening

— Наблюдательное Pancreatic Carcinoma

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: Biospecimen Collection, Magnetic Resonance Cholangiopancreatography, Magnetic Resonance Imaging, Endoscopic ultrasound.
Кому может быть актуально: Состояния в реестре: Pancreatic Carcinoma. 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
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This study investigates how often abnormal findings from routine magnetic resonance imaging occur in people with genetic mutations in BReast CAncer gene. (BRCA), ataxia telangiectasia mutated gene (ATM), or PALB2 screened for pancreatic cancer. This study may lead to a greater understanding of cancer and potentially, improvements in cancer screening and treatment.

Подробное описание

PRIMARY OBJECTIVE:

I. To determine the event rate of abnormal magnetic resonance imaging (MRI) and Endoscopic ultrasound (EUS) findings in screened study participants.

SECONDARY OBJECTIVES:

I. To determine the rates of high-grade pancreatic neoplasia precursors (intraductal papillary mucinous neoplasm (IPMN)-high-grade dysplasia (HGD)) and pancreatic intraepithelial neoplasia-3 \[PanIN-3\]) and pancreatic ductal adenocarcinoma (PDAC) among all study participants.

II. To understand rates of procedures (biopsies and surgeries) among all study participants.

EXPLORATORY OBJECTIVES:

I. To create a biorepository of all participants through the collection of saliva, blood, and tissue, combined with imaging findings and robust clinical annotation of patient health behaviors in all study participants.

II. To explore knowledge, attitudes, and anxiety related to pancreatic cancer screening at annual intervals in all study participants.

OUTLINE: Participants are assigned to 1 of 2 groups.

GROUP I: GROUP I: Participants may opt to undergo MRI/magnetic resonance cholangiopancreatography (MRCP) or alternating MRI/MRCP and EUS annually for 10 years or complete questionnaires over 10 minutes and undergo blood, saliva and tissue sample collection.

GROUP II: Participants may undergo MRI/MRCP or alternating MRI/MRCP and EUS annually for 10 years.

Вмешательства

Процедура Biospecimen Collection
Undergo blood, tissue, and saliva collection
Процедура Magnetic Resonance Cholangiopancreatography
Undergo MRCP
Процедура Magnetic Resonance Imaging
Undergo MRI
Процедура Endoscopic ultrasound
Undergo endoscopic ultrasound
Другое Questionnaires
Complete the following questionnaires: Pancreatic Cancer Knowledge Survey, Pancreatic Cancer Worry Scale, Disease Specific Perceived Risk Survey, eGene Questionnaire

Первичные конечные точки

Proportion of participants with of abnormal magnetic resonance imaging (MRI) findings [Срок оценки: Up to 10 years]

Вторичные конечные точки (4)

Overall Cancer Detection Rate [Срок оценки: Up to 10 years]
Rates of high-grade neoplastic precursors [Срок оценки: Up to 10 years]
Rates of pancreatic ductal adenocarcinoma (PDAC) [Срок оценки: Up to 10 years]
Proportion of participants who have additional medical procedures [Срок оценки: Up to 10 years]

Критерии участия

Критерии включения

Ability to provide consent and willing, and able to comply with study procedures Ability to read and speak English

GROUP I:

Documentation of pathogenic or likely pathogenic germline BRCA 1 and 2, ATM or PALB2 germline genetic mutation
No strong family history of pancreatic cancer (defined as having >= 1 first-degree or second-degree relative with a history of pancreatic cancer)
Age >= 50 years old at time of consent.

GROUP II:

Documentation of pathogenic or likely pathogenic germline BRCA 1 and 2, ATM, or PALB2 germline genetic mutation
Has strong family history of pancreatic cancer (defined as having >= 1 first-degree or second-degree relative with a history of pancreatic cancer)
Age >= 18 years old at time of consent (screening generally begins 10 years prior to the earliest pancreatic cancer in the family)