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Идёт набор NCT06606028

Tumor-Informed ctDNA Testing for MRD Following Treatment of Squamous Cell Carcinoma

— Наблюдательное Squamous Cell Carcinoma of Head and Neck Squamous Cell Carcinoma Head and Neck Cancer (HNSCC) Squamous Cell Carcinoma of Skin Cutaneous Squamous Cell Carcinoma (CSCC)

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, Tumor Tissue Collection, Medical Record Review.
Кому может быть актуально
Состояния в реестре: Squamous Cell Carcinoma of Head and Neck, Squamous Cell Carcinoma Head and Neck Cancer (HNSCC), Squamous Cell Carcinoma of Skin, Cutaneous Squamous Cell Carcinoma (CSCC). 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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Официальное название

Tumor-informed ctDNA Testing for Minimal Residual Disease Monitoring Following Curative-intent Treatment of Squamous Cell Carcinoma of the Head and Neck.

Обзор

This is a single-center, non-interventional, observational study that evaluates the correlation of circulating tumor DNA (ctDNA) testing to cancer relapse for participants with squamous cell carcinomas (HNC) of the head and neck mucosa and skin after curative-intent primary radiation or surgery.

Подробное описание

PRIMARY OBJECTIVE:

I. To determine the rates of detectable ctDNA within two years of participants treated with curative-intent surgery or radiation-based treatment for HNC.

SECONDARY OBJECTIVES:

1. To describe the prevalence of detectable ctDNA at initial diagnosis in participants with HNC. 2. To describe the association of quantitative ctDNA levels with time-to-event outcomes (overall survival (OS), disease-free survival (DFS), and time to recurrence (TTR)). 3. To describe the association of quantitative ctDNA levels with follow-up imaging tumor volume.

OUTLINE:

Participants will have tissue samples collected at screening and blood samples collected for analysis before, during, and after non-investigational, standard of care treatment for cancer for up to 2 years

Вмешательства

  • Процедура Blood Specimen Collection
    Approximately 20 mL of peripheral blood (10 mL per tube, x 3 Streck tubes) will be drawn at each time point
  • Процедура Tumor Tissue Collection
    Formalin-fixed paraffin embedded tumor tissue samples (tissue blocks of 12 x 10 millimeter (mm) unstained slides) derived from biopsy or surgical resection will be collected at screening
  • Другое Medical Record Review
    Medical records will be reviewed to collect standard of care p16 staining by immunohistochemistry and/or high-risk human papillomavirus (HPV) DNA or RNA testing that is performed as part of standard of care

Первичные конечные точки

  • Cumulative incidence rate of ctDNA [Срок оценки: Up to 2 years]
Вторичные конечные точки (5)
  • Proportion of participants at diagnosis with a positive (non-zero) ctDNA result. [Срок оценки: Up to 2 years]
  • Association of association of quantitative ctDNA levels with overall survival (OS) [Срок оценки: Up to 2 years]
  • Association of association of quantitative ctDNA levels with disease-free survival (DFS) [Срок оценки: Up to 2 years]
  • Association of association of quantitative ctDNA levels with time to recurrence (TTR) [Срок оценки: Up to 2 years]
  • Association of quantitative ctDNA levels with follow-up imaging tumor volume. [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

  • Participants must have histologically or cytologically confirmed squamous cell carcinoma of the head and neck mucosa and skin.
  • Participants must be age >=18 years.
  • Participants must be planning to receive curative-intent surgery or radiation-based treatment as part of standard of care treatment.
  • Participants must have the ability to understand and the willingness to sign a written informed consent document.

Критерии исключения

1\. Contraindication to phlebotomy for removal of 20 mL of peripheral blood each time point (up to 300 mL total over 15 time points).

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: NCT06606028 · 232010 · NCI-2024-07739

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗