Меню
Идёт набор NCT06562777

Observational Study of Sex Differences in Symptoms During Immune Checkpoint Inhibitor Treatment for People With Cancer

— Наблюдательное Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

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: Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm. 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

INvestigating Sex and Gender-Related Differences in Immunotherapy Treatment Effects (INSITE)

Обзор

This study aims to learn more about symptoms that patients experience while receiving immunotherapy for cancer.

Подробное описание

PRIMARY OBJECTIVES:

I. Characterize sex differences in patient-reported symptomatic immune-related adverse events.

II. Determine the level of discordance between clinician-assessed and patient-reported symptomatic immune-related adverse events according to patient gender.

OUTLINE: This is an observational study.

Patients complete surveys and have their medical records reviewed on study.

Вмешательства

  • Другое Non-Interventional Study
    Non-Interventional Study

Первичные конечные точки

  • Patient-reported symptoms [Срок оценки: Baseline, weekly thereafter up to 26 weeks]
  • Patient-reported QOL - Part 1 [Срок оценки: Baseline, month 3, month 6]
  • Patient-reported QOL - Part 2 [Срок оценки: Baseline, month 3, month 6]
  • Patient-reported QOL - Part 3 [Срок оценки: Baseline, month 3, month 6]
  • Clinician-assessed patient symptoms [Срок оценки: Baseline, month 3, month 6]

Критерии участия

Критерии включения

  • Age 18 years or older on date of enrollment (Confirmed by review of the date of birth as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)
  • Histologically confirmed diagnosis of cancer and plan to begin SOC immunotherapy for the treatment of cancer per FDA approval and/or National Comprehensive Cancer Network (NCCN) guidelines (Confirmed by review of cancer diagnosis and treatment plan as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)
  • Treating oncologist anticipates at least 6 consecutive months of SOC immunotherapy (Confirmed by review of the treatment plan as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)

Критерии исключения

  • Diagnosed with breast, prostate, testicular, penile, or gynecologic cancer (Confirmed by review of the cancer diagnosis as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)
  • Previously received immunotherapy (Confirmed by review of cancer treatment history as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)
  • Life expectancy of <6 months at time of enrollment per the treating oncologist (Confirmed by the professional opinion of the treating oncologist and subsequently recorded in a CRF.)
  • Concurrently receiving a non-immunotherapy treatment, including chemotherapy, biological, or targeted therapy (Confirmed by review of the treatment plan as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)
  • Concurrently receiving radiation, unless hypofractionated palliative radiation prescribed to alleviate poorly controlled symptoms (e.g. pain) (Confirmed by review of the treatment plan as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)
  • Participation in a clinical trial of experimental immunotherapy (Confirmed by review of the treatment plan as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)
  • Needs to rely on a proxy to complete patient-reported outcome instruments (Confirmed by self-report on Health History Questionnaire.)
  • Unwilling or unable to complete consent form and surveys electronically (Confirmed by successful completion of electronic consent form and baseline survey in REDCap.)

Assessment of participant eligibility is at the discretion of the Principal Investigator, Dr. Deanne Tibbitts.

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
  • OHSU Knight Cancer Institute — Portland

Идентификаторы

NCT: NCT06562777 · STUDY00025328 · NCI-2023-06611 · STUDY00025328

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗