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Набор скоро начнётся NCT07605702

The Canopy Cancer Collective Clinical Registry Protocol

— Наблюдательное Gastrointestinal Neoplasms Pancreatic Cancer Colorectal Cancer GI Cancers

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Gastrointestinal Neoplasms, Pancreatic Cancer, Colorectal Cancer, GI Cancers. 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

The Canopy Cancer Collective Clinical Registry Protocol Non-Interventional Data and Sample Collection Registry Protocol Number of study sites 15 Study Design - Observational, registry Primary Objective To systematically collect and store comprehensive data on gastrointestinal cancer patients, encompassing both their past medical history and future clinical experiences, to address specific future research questions related to these malignancies, to establish and share best practices, and to support quality improvement initiatives focused on enhancing patient care and outcomes. Secondary Objective(s) 1. Leverage the collective to increase access to molecular profile and biomarker (ctDNA) matched clinical trials across the treatment trajectory. 2\. Use real world data and patient reported outcomes to improve patient care throughout the treatment trajectory. Research Procedure(s) Collection of clinical and outcome data and cataloging and facilitating access to physical biological specimens and their associated data for future research purposes. Drugs/Devices used on Study None Study Population Patients with diagnosis of gastrointestinal (GI) cancers who seek care at one of the canopy centers and/or their affiliates Sample Size Up to 30000 patients in the prospective component Up to 70000 subjects will be enrolled on the retrospective component Study Duration for Individual Participants Anticipated to be at least 1 year Study Specific Abbreviations AE: Adverse Event CEC: Clinical Events Committee CT: Computed Tomography iCCA: Intrahepatic cholangiocarcinoma MRI: Magnetic Resonance Imaging OS: Overall Survival PFS: Progression Free Survival

Первичные конечные точки

  • Number of participants enrolled in registry [Срок оценки: Up to 120 months]
Вторичные конечные точки (8)
  • Objective Response Rate (ORR) [Срок оценки: From start of therapy, up to 2 years on average.]
  • Progression-Free Survival (PFS) [Срок оценки: From start of therapy to disease progression or death, up to 2 years on average.]
  • Time to Selection of Next Therapy [Срок оценки: From start of therapy to start of subsequent therapy, up to 2 years on average]
  • Molecular Testing Rate [Срок оценки: Through patient follow-up, up to 2 years on average.]
  • Clinical Trial Offer / Enrollment Rate [Срок оценки: Through patient follow-up, up to 2 years on average.]
  • Targeted Therapy Utilization [Срок оценки: Through patient follow-up, up to 2 years on average.]
  • Overall Survival (OS) [Срок оценки: Through patient follow-up, up to 2 years on average.]
  • Patient-Reported Outcomes (PROMs/PREMs) [Срок оценки: Through patient follow-up, up to 2 years on average.]

Критерии участия

Критерии включения

Retrospective Cohort:

  • Must have reached the age of majority in the jurisdiction where enrolled (18 years; Alabama/Nebraska 19; Puerto Rico 21).
  • Must have histologically proven GI cancer seen at the site within the 20 years preceding activation, and are:
  • Deceased, or
  • Lost to follow-up ( >1 year lapse in contact since last visit).

Prospective Cohort:

  • Must have reached the age of majority in the jurisdiction where enrolled (18 years; Alabama/Nebraska 19; Puerto Rico 21).
  • Must have histologically proven Gastrointestinal (GI) cancer.
  • Patient or legally authorized representative capable of understanding and willing to provide signed informed consent (assent if applicable).
  • Patient/Legally Authorized Representative (LAR) agrees to collection of clinical data and information available on archival tissue and subsequent excess specimens obtained as part of standard-of-care.

Критерии исключения

Retrospective Cohort:

1\. Cases in which patient's medical chart denotes restricted use of health information.

Prospective Cohort:

1\. Prisoners will not be approached for participation.

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 · 10 центров
  • UC San Diego Health — San Diego
  • Moffitt Cancer Center — Tampa
  • Sidney Kimmel Comprehensive Cancer Center — Baltimore
  • Roswell Park Comprehensive Cancer Center — Buffalo
  • Northwell Health — Lake Success
  • Mt. Sinai — New York
  • Cleveland Clinic — Cleveland
  • UT Southwestern Medical Center — Dallas
  • … и ещё 2 центра

Идентификаторы

NCT: NCT07605702 · CCC001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗