Fatigue and Molecular Mechanisms in Cancer Patients Receiving CCRT
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: Blood Specimen Collection, Stool Specimen Collection, Quality of Life (QOL) Questionnaires.
- Кому может быть актуально
- Состояния в реестре: Cancer, Thoracic Cancer, Gynecologic Cancer, Head and Neck Cancer. 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 →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
An Evaluation of Changes in the Relationships Between Fatigue and Molecular Mechanisms in Cancer Patients Receiving Curative-Intent Combined Chemotherapy and Radiation Therapy (CCRT)
Обзор
Cancer-related fatigue (CRF) is a significant problem for cancer patients. This prospective, basic science, observational study will evaluate for changes in CRF associated with molecular characteristics prior to, during, and at the completion of non-investigational, standard-of-care, combined chemotherapy and radiation therapy (CCRT) and to develop and assess predictive models for CRF severity.
Подробное описание
Primary Objective For mean, morning and evening CRF:
Aim 1. Evaluate for associations between phenotypic characteristics and initial levels and the trajectories of CRF.
Aim 2. Evaluate for associations between changes in CRF severity and changes in gene expression levels prior to the initiation and at the end of CCRT.
Aim 3. Evaluate for associations between changes in CRF severity and changes in circulating free cytokine levels prior to the initiation and at the end of CCRT.
Aim 4. Develop and assess predictive models for CRF severity midway, at the end of, and at least six months post-CCRT using demographic, clinical, and molecular characteristics collected prior the initiation of CCRT.
Secondary Objectives For the commonly co-occurring symptom of chemotherapy-induced peripheral neuropathy (CIPN):
Secondary Aim 5. Evaluate for associations between phenotypic characteristics and initial levels and the trajectories of CIPN.
Secondary Aim 6. Evaluate for associations between changes in CIPN severity and changes in gene expression levels prior to the initiation and at the end of CCRT.
Secondary Aim 7. Evaluate for associations between changes in CIPN severity and changes in circulating free cytokine levels prior to the initiation and at the end of CCRT.
Secondary Aim 8. Develop and assess predictive models for CIPN severity midway, at the end of, and at least six months post-CCRT using demographic, clinical, and molecular characteristics collected prior the initiation of CCRT.
Exploratory Aim 1 - Evaluate the feasibility of the protocol for the collection of stool samples.
Exploratory Aim 2 - Evaluate the feasibility of processing and storing stool samples.
Exploratory Aim 3 - Evaluate the feasibility of processing and storing performing blood samples and performing Cytometry by time of flight (CyTOF) assays.
Вмешательства
- Процедура Blood Specimen Collection
Blood samples will be obtained throughout the course of the study - Другое Stool Specimen Collection
Stool samples will be obtained throughout the course of the study - Другое Quality of Life (QOL) Questionnaires
Surveys will be given throughout the course of the study.
Первичные конечные точки
- Measure associations between changes in cancer-related fatigue (CRF) and changes in gene expression over time [Срок оценки: Up to 34 weeks]
- Measure associations between changes in CRF and changes in cytokine levels over time [Срок оценки: Up to 34 weeks]
- Measure associations between changes in CRF and changes in gene expression over time [Срок оценки: Up to 34 weeks]
- Evaluate the predictive utility of gene expression and cytokine data [Срок оценки: Up to 34 weeks]
Вторичные конечные точки (5)
- Evaluate for associations between changes in chemotherapy-induced peripheral neuropathy (CIPN) and changes in gene expression [Срок оценки: Up to 34 weeks]
- Evaluate for associations between changes in CIPN and changes in cytokine levels [Срок оценки: Up to 34 weeks]
- Evaluate the predictive utility of gene expression and severity of CIPN [Срок оценки: Up to 34 weeks]
- Evaluate the predictive utility of cytokine levels and severity of CIPN [Срок оценки: Up to 34 weeks]
- Evaluate the predictive model of severity of CIPN [Срок оценки: Up to 34 weeks]
Критерии участия
Критерии включения
- Participants have not received any prior treatment (i.e., cancer systemic therapies or radiation therapy) in the month except surgery or inductive Chemotherapy (CTX).
- Participants receiving >= 15 fractions.
- Participants is male or female and is >18 years of age on the day of signing the informed consent.
- Ability to understand a written informed consent document.
- Able and willing to complete all of the study questionnaires and provide blood and stool samples prior to, midway, and following the completion of treatment.
- Willing to have medical records reviewed for clinical information.
- Able to read, write and understand English or Spanish.
Критерии исключения
- Contraindication to phlebotomy for removal of approximately 50 mL of peripheral blood within 6 week period (Institutional Review Board (IRB) limit).
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
- University of California, San Francisco — San Francisco
Идентификаторы
NCT: NCT06633224 · 239814 · R37CA233774 · NCI-2024-08455