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Идёт набор NCT06651580

Biospecimen Collection to Identify Gene Mutations for High Risk Pancreatic Cancer in Pediatric Patients, INSPPIRE 2 Study

— Наблюдательное Chronic Pancreatitis Exocrine Pancreas Carcinoma Recurrent Acute Pancreatitis

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, Quality-of-Life Assessment, Questionnaire Administration.
Кому может быть актуально
Состояния в реестре: Chronic Pancreatitis, Exocrine Pancreas Carcinoma, Recurrent Acute Pancreatitis. Базовые параметры: до 17 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, Австралия, Канада, 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

Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPPIRE 2)

Обзор

This clinical trial collects blood, saliva, urine, or stool samples to help identify possible genetic mutations that may increase a person's chance at developing pancreatic cancer. Finding genetic markers among pediatric patients with acute recurrent pancreatitis and chronic pancreatitis may help identify patients who are at risk of pancreatic cancer.

Подробное описание

PRIMARY OBJECTIVE:

I. To comprehensively characterize the pediatric population with acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP) and determine predictors of early onset CP and its sequelae.

OUTLINE:

Patients complete quality-of-life (QoL) assessment and complete questionnaires for over 2 hours every 12 months for 4 years. Patients also undergo collection of blood and/or saliva (if blood samples are not available), urine, or stool at baseline or follow-up (if inadequate samples collected or missed at baseline).

After completion of the study, patients are followed up every 12 months.

Вмешательства

  • Процедура Biospecimen Collection
    Undergo collection of blood, saliva, urine or stool samples
  • Другое Quality-of-Life Assessment
    Complete QoL assessment
  • Другое Questionnaire Administration
    Complete questionnaire

Первичные конечные точки

  • Characterize the pediatric population with acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP) [Срок оценки: Up to 4 years]
  • Risk factors that predispose children to CP sequelae and high disease burden [Срок оценки: Up to 4 years]

Критерии участия

Критерии включения

  • All subjects/parents must sign an informed consent and/or assent indicating that they are aware of the investigational nature of this study
  • Subjects/parents must have signed an authorization for the release of their or their child's protected health information
  • All children must be under 18 years of age at the time of enrollment
  • All children providing samples should fit the ARP or CP inclusion criteria defined below:
  • Acute pancreatitis (AP): AP is defined as requiring 2 of the following:
  • Abdominal pain compatible with AP
  • Serum amylase and/or lipase values >= 3 times upper limits of normal
  • Imaging findings of AP, such as gland enlargement, acute inflammatory changes, and fluid collections
  • ARP is defined as: At least 2 episodes of acute pancreatitis with complete resolution of pain and a >= 1 month pain-free interval between episodes
  • Chronic Pancreatitis:
  • Children with at least:
  • One irreversible structural change in the pancreas with or without abdominal pain +/- exocrine pancreatic insufficiency +/- diabetes
  • Irreversible structural changes:
  • Ductal calculi, dilated side branches, parenchymal calcifications found in any imaging (abdominal ultrasound \[abd US\], magnetic resonance imaging/magnetic resonance cholangiopancreatography \[MRI/MRCP\], computerized tomography \[CT\], endoscopic retrograde cholangiopancreatography \[ERCP\], endoscopic US \[EUS\])
  • Ductal obstruction or stricture/dilatation/irregularities that are persistent (for >= 2 months) on any imaging
  • Parenchymal atrophy, irregular contour, accentuated lobular architecture, cavities alone are not diagnostic findings for CP
  • Surgical or pancreatic biopsy specimen demonstrating histopathologic features compatible with CP (acinar atrophy, fibrosis, protein plugs, infiltration with lymphocytes, plasma cells, macrophages)

Критерии исключения

  • Subjects must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the subject's ability to tolerate study interventions

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 · 22 центра
  • Children's Hospital Los Angeles — Los Angeles
  • Cedars Sinai Medical Center — Los Angeles
  • UCSF Benioff Children's Hospital Oakland — Oakland
  • Stanford Cancer Institute Palo Alto — Palo Alto
  • University of Colorado — Denver
  • Emory University Hospital/Winship Cancer Institute — Atlanta
  • Riley Hospital for Children — Indianapolis
  • University of Iowa/Holden Comprehensive Cancer Center — Iowa City
  • … и ещё 14 центров
Канада · 2 центра
  • Hospital for Sick Children — Toronto
  • The Montreal Children's Hospital of the MUHC — Montreal
Австралия · 1 центр
  • Sydney Children's Hospital — Randwick
Израиль · 1 центр
  • Hadassah University Hospital — Jerusalem

Идентификаторы

NCT: NCT06651580 · 2020-1057 · NCI-2021-04028 · 2020-1057 · P30CA016672

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗