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Идёт набор NCT07675967

Clonal Hematopoiesis Chemotherapy and Radiation Effects Study

— Наблюдательное Lung Cancer (Diagnosis) Osteochondroma Spitz Nevus Solid 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
В протоколе указаны: Samples.
Кому может быть актуально
Состояния в реестре: Lung Cancer (Diagnosis), Osteochondroma, Spitz Nevus, Solid 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 goal of the Clonal Hematopoiesis Chemotherapy and Radiation Effects (CH CARE) Study is to understand how the presence or absence of clonal hematopoiesis (CH) influences outcomes in people receiving chemotherapy and radiation for solid cancers. The study will collect biospecimens and clinical information. These data will be used to define clinical and molecular features that predict the presence of high-risk clonal hematopoiesis (CH) in patients exposed to cytotoxic anti-cancer therapy. Predictive features will be utilized to identify populations of cancer patients and survivors who are at the highest risk of developing therapy-related myeloid neoplasms (t-MNs). Ultimately this study will result in the development of a novel novel risk prediction algorithm for t-MNs in patients with solid cancers and drive potential therapeutic approaches to intercept progression from CH to often fatal t-MNs.

Подробное описание

The objective of this protocol is to obtain clinical information and facilitate the collection and distribution of specimens obtained during the course of clinical care or research participation.

Blood, buccal swabs, or other body fluids may be specifically acquired for research in order to perform molecular and other types of analyses for research purposes. These materials will be collected from all eligible participants. It is expected that about 5,000 people will take part in this research study.

Вмешательства

  • Другое Samples
    Tissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types: Blood, Buccal swab (saliva) or mouthwash, Urine, Stool, Biopsy or surgical tissue (i.e., bone marrow),Bodily fluids, Other tissues

Первичные конечные точки

  • Prevalence of clonal hematopoiesis [Срок оценки: Baseline]
  • Gene distribution of clonal hematopoiesis [Срок оценки: baseline]
  • Change in clonal hematopoiesis variant allele fraction [Срок оценки: Up to 5 years; assessed at time 0, 6 months, and annually]
  • Solid malignancy progression [Срок оценки: Up to 5 years]
  • Overall survival [Срок оценки: Up to 5 years]
  • Development of hematologic toxicity [Срок оценки: Up to 5 years]
  • Development of therapy-related myeloid neoplasm (t-MN) [Срок оценки: Up to 10 years]
Вторичные конечные точки (1)
  • Development of a predictive algorithm for adverse clinical outcomes in patients with clonal hematopoiesis [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

  • Participants to be included in this study include the following:
  • Adults age >18 years
  • Diagnosed with solid malignancy (breast, ovarian, lung, gastric, colorectal, esophageal, uterine, head and neck, or sarcoma cancers)
  • Have a pending plan to receive chemotherapy or radiation for their solid malignancy (cancer).
  • Has not received cytotoxic chemotherapy or radiation for their solid cancer diagnosis in the past.

Критерии исключения

  • Individuals without plans for cytotoxic chemotherapy, radiation or PARP inhibitor exposure
  • Individuals who have received prior chemotherapy and or radiation for their current solid malignancy (cancer)
  • Individuals with any prior history of blood cancer (leukemia, myelodysplastic syndrome, lymphoma, multiple myeloma, including smoldering multiple myeloma). Persons with blood cancer precursors including clonal hematopoiesis of indeterminate potential (CHIP), clonal cytopenia of uncertain significance (CCUS), monoclonal B lymphocytosis (MBL), monoclonal gammopathy of uncertain significance (MGUS) are eligible for study 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 · 1 центр
  • Dana-Farber Cancer Institute — Boston

Публикации

  • Weeks LD, Ebert BL. Clonal Hematopoiesis as a Driver of Solid Tumors. N Engl J Med. 2025 Apr 24;392(16):1654-1656. doi: 10.1056/NEJMe2504775. No abstract available. PMID 40267434
  • Morganti S, Gibson CJ, Jin Q, Santos K, Patel A, Wilson A, Merrill M, Vincuilla J, Stokes S, Lipsyc-Sharf M, Parker T, King TA, Mittendorf EA, Curigliano G, Hughes ME, Stover DG, Tolaney SM, Weeks LD, Tayob N, Lin NU, Garber JE, Miller PG, Parsons HA. Prevalence, Dynamics, and Prognostic Role of Clonal Hematopoiesis of Indeterminate Potential in Patients With Breast Cancer. J Clin Oncol. 2024 Nov; PMID 38190580
  • Weeks LD, Ebert BL. Causes and consequences of clonal hematopoiesis. Blood. 2023 Dec 28;142(26):2235-2246. doi: 10.1182/blood.2023022222. PMID 37931207
  • Weeks LD, Niroula A, Neuberg D, Wong W, Lindsley RC, Luskin M, Berliner N, Stone RM, DeAngelo DJ, Soiffer R, Uddin MM, Griffin G, Vlasschaert C, Gibson CJ, Jaiswal S, Bick AG, Malcovati L, Natarajan P, Ebert BL. Prediction of risk for myeloid malignancy in clonal hematopoiesis. NEJM Evid. 2023 May;2(5):10.1056/evidoa2200310. doi: 10.1056/evidoa2200310. Epub 2023 Apr 25. PMID 37483562

Идентификаторы

NCT: NCT07675967 · 24-431

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗