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Идёт набор NCT04739072

Minimal Residual Disease Assessment in Patients With Colorectal Cancer, the MiRDA-C Study

— Наблюдательное Colorectal Adenocarcinoma Stage I Colorectal Cancer AJCC v8 Stage II Colorectal Cancer AJCC v8 Stage IIA Colorectal Cancer AJCC v8

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: Biospecimen Collection, Electronic Health Record Review.
Кому может быть актуально
Состояния в реестре: Colorectal Adenocarcinoma, Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage IIA Colorectal Cancer AJCC v8. 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

Minimal Residual Disease Assessment in Colorectal Cancer (MiRDA-C)

Обзор

This study investigates if circulating tumor DNA (ctDNA) and other tumor-related molecules/chemicals released in the blood can help doctors predict if colorectal cancer may come back or spread. Tumors shed DNA and other cancer related chemicals into the blood that can be identified and studied further to provide information about the cancer. Information gathered from this study may help researchers better understand if ctDNA found in the blood can predict whether colorectal cancer may come back or spread.

Подробное описание

PRIMARY OBJECTIVES:

I. Demonstrate ability to monitor cancer-specific deoxyribonucleic acid (DNA), ribonucleic acid (RNA), and proteomic alterations from plasma.

II. Improve detection of recurrences post completion of curative therapies through monitoring of plasma cancer-specific DNA, RNA and proteomic alterations.

SECONDARY OBJECTIVES:

I. Qualitative and quantitative changes in cancer-specific plasma alterations during neoadjuvant, adjuvant therapies and surveillance.

II. Disease free survival (DFS) of patients with detectable cancer-specific plasma alterations.

III. Overall survival (OS) of patients with detectable cancer-specific plasma alterations.

EXPLORATORY OBJECTIVES:

I. Optimal combination of cancer-specific plasma DNA, RNA and / or proteomic alterations for early detection of recurrences.

II. Sensitivity, specificity, positive predictive and negative predictive values of cancer-specific plasma alterations in detecting recurrences.

III. Correlation between cancer-specific alterations in plasma and tissue and either with outcomes including DFS \& OS.

IV. Nature and frequency of detection of incidental non-colorectal cancer related DNA, RNA and / or proteomic alterations.

OUTLINE:

Patients undergo collection of blood samples at baseline, during each neoadjuvant therapy treatment, prior to surgical resection, and up to 4 times per year for up to 5 years. Patients also undergo collection of tissue sample at time of surgical resection. Patients' medical records may also be reviewed.

Вмешательства

  • Процедура Biospecimen Collection
    Undergo collection of blood and tissue samples
  • Другое Electronic Health Record Review
    Review of medical records

Первичные конечные точки

  • Analysis of deoxyribonucleic (DNA), ribonucleic acid (RNA), and proteomic alterations from plasma [Срок оценки: Up to 5 years]
  • Detection of recurrences post completion of curative therapies [Срок оценки: Up to 5 years]
Вторичные конечные точки (3)
  • Changes in cancer-specific plasma alterations during neoadjuvant, adjuvant therapies and surveillance [Срок оценки: Baseline up to 5 years]
  • Disease free survival (DFS) [Срок оценки: Up to 5 years]
  • Overall survival (OS) [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

  • Age ≥ 18 years.
  • Histological/cytological confirmation of colorectal adenocarcinoma.
  • Patients with any stage colorectal adenocarcinoma deemed potentially eligible for curative intent treatment. Patients with stages II-IV colorectal cancer post-R0 resection may also be enrolled onto the protocol any time before or up to 3 months post-surgery and prior to initiating adjuvant therapy.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Willing to pursue standard of care surveillance post completion of curative therapies.
  • Willing to provide blood samples for correlative research.

Критерии исключения

  • Known active malignancies other than colorectal adenocarcinoma that may interfere with detection and / or interpretation of circulating plasma markers. Patients with known clonal hematopoiesis of indeterminate potential are eligible.
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

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
  • Banner - MD Anderson Cancer Center — Gilbert
  • Baptist- MD Anderson Cancer Center — Jacksonville
  • The Queen's Medical Center — Honolulu
  • St. Luke's Cancer Institute — Boise
  • Cooper Hospital UNIV MED CTR. — Camden
  • UT Southwestern/Simmons Cancer Center-Dallas — Dallas
  • Houston Methodist Cancer Center — Houston
  • M D Anderson Cancer Center — Houston
  • … и ещё 2 центра

Идентификаторы

NCT: NCT04739072 · PA18-1171 · NCI-2020-10034 · PA18-1171

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗