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Идёт набор NCT06271291

Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts

— 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: Non-Interventional Study.
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 evaluates individuals without pancreatic cancer, but who have been determined to be at higher-than-average lifetime risk of developing pancreatic cancer to help detect pancreatic cancer or other cancers at an earlier time when they might be more easily treated and cured.

Подробное описание

PRIMARY OBJECTIVES:

I. To develop a cohort (biobank of biospecimens and data) of subjects without pancreatic cancer who are at highrisk for pancreatic cancer due to: a strong family history, a mutation in a known pancreatic cancer predisposition gene, or fukuoka worrisome or high-risk pancreatic cysts.

II. To follow the cohort subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes.

III. To make biospecimen available to PCDC-approved projects to validate potential biomarkers for performance using nested case-control prospective designs.

OUTLINE: This is an observational study.

Participants undergo blood sample collection, complete questionnaires, have their medical records reviewed and undergo pancreatic cyst fluid collection during standard of care endoscopic ultrasounds fine needle aspiration.

Вмешательства

  • Другое Non-Interventional Study
    Non-interventional study

Первичные конечные точки

  • Develop a biobank of biospecimens and data of subjects without pancreatic cancer who are at high risk for pancreatic cancer [Срок оценки: Baseline (at enrollment)]
  • Follow subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes [Срок оценки: Up to study completion, as defined in description]

Критерии участия

Критерии включения

  • PDAC FAMILY HISTORY OR PDAC RELATED GENETIC MUTATIONS:
  • Age: 50 or older, plus at least one of the following:
  • Mutation unknown or absent:
  • 2+ relatives with PDAC on same side of family where 2 affected are first degree related to each other and at least 1 affected is first degree related to subject;
  • OR 2+ affected first degree relatives \[(FDR), defined as blood related parents, siblings, or children\]
  • Known pathogenic/likely pathogenic (P/LP) mutation in at least one of the following:
  • CDKN2A/p16, Peutz-Jeghers syndrome (PJS) serine/threonine kinase 11 (STK11), Hereditary pancreatitis with confirmed protease serine 1 (PRSS1)
  • OR 1+ or second degree relative (SDR) with PDAC and a known P/LP mutation in one or more of:
  • ATM, BRCA1, BRCA2, PALB2, Lynch syndrome (MLH1, MSH2, MSH6, PMS2, EPCAM), TP53
  • HIGH-RISK OR WORRISOME PANCREATIC CYSTS:
  • 18 years of age or greater and meeting Fukuoka worrisome (FW) or Fukuoka high-risk (FHR) criteria
  • High risk stigmata:
  • Obstructive Jaundice in a patient with cystic lesion of the head of the pancreas
  • Enhancing mural nodule ≥ 5 mm
  • Main pancreatic duct ≥ 10 mm
  • Worrisome features:
  • Presence of pancreatic duct stricture, defined as focal pancreatic duct narrowing with upstream duct => 6 mm
  • Cyst ≥ 3 cm
  • Enhancing mural nodule < 5 mm
  • Thickened/Enhancing cyst wall
  • Main duct size 5-9 mm
  • Pancreatitis
  • Lymphadenopathy
  • Increased CA 19-9
  • Cyst growth rate ≥ 5 mm /2 years

Критерии исключения

  • Is unable to provide informed consent
  • Has received a non-autologous bone marrow transplant or has an active hematologic malignancy (i.e., leukemia or lymphoma)
  • Current or prior history of PDAC or total pancreatectomy
  • Is currently a prison inmate
  • Is not able to speak or read English

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 · 9 центров
  • HonorHealth Research Institute — Scottsdale
  • Piedmont Healthcare — Atlanta
  • OSF Saint Francis Medical Center — Peoria
  • The Johns Hopkins University School of Medicine — Baltimore
  • Dana-Farber Cancer Institute — Boston
  • Mayo Clinic in Rochester — Rochester
  • University of Nebraska Medical Center — Omaha
  • Oregon Health & Science University — Portland
  • … и ещё 1 центр

Идентификаторы

NCT: NCT06271291 · 23-000161 · U01CA210138 · U24CA274496

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗