Идёт набор NCT07060716

Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring

— Наблюдательное Kidney Transplant Rejection Cell-free DNA

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: donor-derived cell-free DNA test.
Кому может быть актуально: Состояния в реестре: Kidney Transplant Rejection, Cell-free DNA. 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, Германия
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

GraftAssureDx Study: Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring

Обзор

The goal of this observational study is to learn if the donor-derived cell-free DNA (dd-cfDNA) test can assess rejection in kidney transplant recipients. Participants will have blood and urine collected at their study visit. Researchers will compare results of the GraftAssureDx to rejection detected by standard-of-care graft biopsies.

Вмешательства

Диагностический тест donor-derived cell-free DNA test
A donor-derived cell-free DNA (dd-cfDNA) test used to measure the concentration of total cell-free DNA and the fractional abundance of the dd-cfDNA.

Первичные конечные точки

Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection [Срок оценки: Samples tested after final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 18 weeks after acquisition of the samples.]
Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection [Срок оценки: Samples tested after the final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples.]
Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection [Срок оценки: Samples tested after the assay final cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples.]
Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection [Срок оценки: Samples tested after the final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples.]
Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection [Срок оценки: Samples tested after the final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples.]

Вторичные конечные точки (2)

ROC-AUC of dd-cfDNA vs. biopsy-confirmed rejection. [Срок оценки: This testing will occur from assay cutoff up to 24 weeks after acquisition of the samples.]
Correlation between GraftAssureDx results and traditional biomarkers of kidney rejection (creatinine, estimated glomerular filtration rate, blood urea nitrogen). [Срок оценки: This testing will occur from assay cutoff up to 24 weeks after acquisition of the samples.]

Критерии участия

Критерии включения

Subject is 18 years of age or older
At least 12 calendar days have elapsed since the subject received a kidney transplant.
Subject has provided legally effective informed consent
Subject agrees to comply with all study procedures

Критерии исключения

Kidney donor is an identical twin of the subject.
The subject has another previously transplanted organ in situ.
Subject has received a hematopoietic stem cell transplant.
Subject has received a bone marrow graft.
Subject has self-reported as pregnant.
In the opinion of the investigator, the subject's participation in the study would pose a risk to data integrity or to the subject's safety and welfare.

Sample Inclusion Criteria:

1\. A graft biopsy is obtained within ±1 week of blood draw.

If blood draw is obtained after biopsy, blood draw should be taken at least 2 days after an uncomplicated biopsy procedure.

Sample Exclusion Criteria:

Sample collected from someone that had an invasive graft biopsy ≤ 48 hours prior to blood draw.
Sample collected from subject that received immunosuppressive treatment for biopsy-proven acute rejection ≤ 30 days prior to blood draw
Sample collected from subject that received a blood transfusion ≤ 30 days prior to blood draw.
Sample collected from a subject that provided another sample for the study within the past 7 days.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет