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Идёт набор NCT05049538

Determine the Utility of Liquid Biopsies and Tumor Molecular Profiling in Predicting Recurrence in Endometrial Cancers

— Наблюдательное Endometrial Clear Cell Adenocarcinoma Endometrial Dedifferentiated Carcinoma Endometrial Mucinous Adenocarcinoma Endometrial Serous Adenocarcinoma

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, Liquid Biopsy, Pap Smear.
Кому может быть актуально
Состояния в реестре: Endometrial Clear Cell Adenocarcinoma, Endometrial Dedifferentiated Carcinoma, Endometrial Mucinous Adenocarcinoma, Endometrial Serous Adenocarcinoma. Базовые параметры: от 18 лет · Женщины.
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

A Pilot Investigation to Determine the Utility of Liquid Biopsies and Tumor Molecular Profiling in Predicting Recurrence in Endometrial Cancer

Обзор

This study is to find out how well liquid biopsies work as a non-invasive alternative to other methods of finding cancer cells (such as a tissue biopsy) in patients with endometrial cancer. A liquid biopsy is a blood test that may be able to find cancer cells. Collecting and storing samples of blood and tissue from patients with endometrial cancer to study in the laboratory may help doctors learn how the cells in the blood may change during treatment for uterine cancer.

Подробное описание

PRIMARY OBJECTIVES:

I. Compare TP53, FBXW7, and other mutated gene variant allele frequencies (VAF) in serial circulating cell free deoxyribonucleic acid (ccfDNA) samples obtained from patients with endometrial cancer subtypes during the primary treatment course, which may include pretreatment, post-surgical removal, post adjuvant treatment, and at time of recurrence.

II. Compare the findings from the liquid biopsy mutational analysis to next generation sequencing from the primary tumor.

EXPLORATORY OBJECTIVES:

I. To estimate the presence of malignant cells in the vagina before and after minimally invasive hysterectomy among patients with endometrial cancer.

II. Characterize the immune profile and single cell ribonucleic acid (RNA) sequencing (scRNAseq) profile of endometrial cancer subtypes.

III. Estimate time to progression (TTP), and investigate potential correlations between mutated gene variant allele frequency (VAF) ccfDNA samples and progression.

IV. Compare the efficacy of experimental ccfDNA assays to approved ccfDNA assay using the same samples.

OUTLINE:

Patients undergo collection of blood samples for liquid biopsy during pre-treatment consultation before hysterectomy, after hysterectomy but before starting any chemotherapy, and at the end of last chemotherapy cycle. Patients also undergo collection of tissue samples during hysterectomy. Patients may also undergo Pap smears before and after hysterectomy.

Вмешательства

  • Процедура Biospecimen Collection
    Undergo collection of blood and tissue samples
  • Процедура Liquid Biopsy
    Undergo liquid biopsy
  • Другое Pap Smear
    Undergo Pap smear

Первичные конечные точки

  • Proportion of circulating cell free deoxyribonucleic acid (ccfDNA) mutations [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • Women age 18 years and older
  • Histologic diagnosis of endometrial cancer
  • Candidate for primary surgical treatment or has recently had prior primary surgery
  • Willing and able to provide informed consent

Критерии исключения

Patients who have received prior treatment including chemotherapy or radiation therapy for endometrial cancer. Prior hormonal therapy for the treatment of endometrial cancer is allowed. Patients with prior primary surgery will be allowed to enroll in this trial if the patient has not received any chemotherapy or radiation at the time of enrollment. Note: patients with a history of other cancers may be enrolled after discussion with the PI if it is determined that they are at low risk for recurrence or metastasis.

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
  • M D Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT05049538 · PA19-0309 · NCI-2021-08621

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗