Clinical trials: sponsored by Natera, Inc.
NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Cancer)
A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced / Metastatic Solid Tumors.
This is a multicenter, open-label, randomized (1:1) trial designed to evaluate whether ctDNA-guided interruption of immune-checkpoint inhibitor (ICI) therapy provides comparable survival to standard of care (SoC) continuous ICI…
- Conditions
- NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Carcinoma), NSCLC
- Trial name
- SIGNAL-IO 301 (NCT07689812)
- Testing
- Signatera Genome ultra-sensitive ctDNA blood test
- Volunteers
- 920 people
- Sponsor
- Natera, Inc.
Breast Neoplasms, Carcinoma, Ductal, Breast
Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of ctDNA-guided initiation of CDK4/6 inhibitor therapy using the Signatera™ Designed on Genome test (referred to as "Signatera Genome") in participants with…
- Conditions
- Breast Neoplasms, Carcinoma, Ductal, Breast, Receptors, Estrogen (for ER-positive Requirement)
- Trial name
- SIGNAL-ER 101 (NCT07214532)
- Testing
- ctDNA-Guided Treatment Strategy
- Where
- 49 sites in United States
- Volunteers
- 725 people
- Sponsor
- Natera, Inc.
Vanishing Twin, Trisomy 21
Verification of Risk Assignment for Whole Chromosome Using SNP-based NIPT in Vanishing Twin Pregnancies
The purpose of this study is to collect blood samples from women carrying a vanishing twin pregnancy to further develop Natera's non-invasive prenatal screening test to provide information about possible chromosomal conditions…
- Conditions
- Vanishing Twin, Trisomy 21, Trisomy 13, Trisomy 18
- Trial name
- VANISH (NCT05004337)
- Where
- 21 sites in United States
- Volunteers
- 136 people
- Sponsor
- Natera, Inc.
Non-Muscle Invasive Bladder Cancer, NMIBC
Sample Collection for Ongoing Research and Product Evaluation Study - Non-muscle Invasive Bladder Cancer (SCORE-NMIBC)
The SCORE-NMIBC study is a prospective, multi-center, study designed to collect data and biological samples from participants diagnosed with non-muscle Invasive Bladder Cancer (NMIBC).
- Conditions
- Non-Muscle Invasive Bladder Cancer, NMIBC, High-risk Non-Muscle Invasive Bladder Cancer
- Trial name
- SCORE-NMIBC (NCT07763197)
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Natera, Inc.
Non-Hodgkin Lymphoma, T-Cell Lymphoma
Sample Collection for Ongoing Research and Product Evaluation Study - Non-Hodgkin Lymphoma (SCORE-NHL)
The SCORE-NHL study is a prospective, multi-center, study designed to collect data and biological samples from participants diagnosed with aggressive Stage I to IV non-Hodgkin Lymphoma (NHL).
- Conditions
- Non-Hodgkin Lymphoma, T-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, High-Grade B-Cell Lymphoma
- Trial name
- SCORE-NHL (NCT07750886)
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Natera, Inc.
Kidney Transplant, Immunosuppresion
Immunosuppression Optimization Using The Prospera Assay In Kidney Transplant Recipients (IMPAKT)
IMPAKT is a research study that looks at whether a blood test called Prospera™ can help doctors better adjust anti-rejection medications, compared to the usual way doctors manage these medications without using this test.
- Trial name
- IMPAKT (NCT07718633)
- Testing
- Prospera Immunosuppression Optimization
- Volunteers
- 750 people
- Sponsor
- Natera, Inc.
Endometrial Cancer
Signatera Assessment in Early-Stage Endometrial Cancer
The goal of this clinical trial is to assess if circulating tumor DNA can guide adjuvant selection in high-intermediate risk early-stage endometrial cancer.
- Trial name
- SIGNAL-EMC 101 (NCT07339384)
- Testing
- Signatera Genome ultra-sensitive ctDNA blood test
- Where
- 12 sites in United States
- Volunteers
- 1,010 people
- Sponsor
- Natera, Inc.
Gastric-Esophageal Cancer
Signatera-Guided De-escalation of Adjuvant Therapy in Resectable Stage II-IVa Gastric/Gastric-Esophageal Cancer
The goal of this clinical trial is to assess if circulating tumor DNA, as assessed by Signatera tumor-informed MRD assay, can guide de-escalation of adjuvant therapy in patients with resectable Stage II-IVa…
- Trial name
- SIGNAL GEC-101 (NCT07565857)
- Testing
- Signatera Genome ultra-sensitive ctDNA blood test
- Volunteers
- 1,000 people
- Sponsor
- Natera, Inc.
Single Gene NIPT
EXpanding Prenatal Cell Free DNA Screening Across moNogenic Disorders (EXPAND)
The purpose of this research is to develop and validate a single gene Non-Invasive Prenatal Test. The development of this investigational single-gene noninvasive prenatal testing (sgNIPT) for conditions such as cystic fibrosis…
- Trial name
- EXPAND (NCT06808880)
- Testing
- Single-gene Noninvasive Prenatal Testing (sgNIPT)
- Where
- 18 sites in United States
- Volunteers
- 4,000 people
- Sponsor
- Natera, Inc.
Heart Transplant Failure and Rejection
A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy
This is an open label Comparative Effectiveness Research (CER) study in which patients will be randomized at the site level to Prospera surveillance or EMB surveillance in a 2:1 ratio (Prospera to EMB) at each site.
- Trial name
- ACES-EMB (NCT06414603)
- Testing
- The Prospera™ Test
- Where
- 16 sites in United States
- Volunteers
- 250 people
- Sponsor
- Natera, Inc.
Breast Cancer, Lung Cancer
Sample Collection for Ongoing Research and Product Evaluation Study
The SCORE study is a prospective, multi-site clinical trial designed to collect blood and tissue samples, along with relevant clinical data, from participants diagnosed with various solid tumors.
- Conditions
- Breast Cancer, Lung Cancer, Muscle Invasive Bladder Cancer, Rectal Cancer
- Trial name
- SCORE (NCT07318051)
- Where
- United States
- Volunteers
- 9,600 people
- Sponsor
- Natera, Inc.
Colo-rectal Cancer
Evaluation of the Natera Colorectal Cancer Screening Test in an Average Risk Population (FIND-CRC)
The FIND-CRC study is a prospective collection of samples and data from participants who are at average risk of developing colorectal cancer (CRC).
- Trial name
- FIND-CRC (NCT07046585)
- Where
- United States
- Volunteers
- 25,000 people, healthy volunteers welcome
- Sponsor
- Natera, Inc.
Lung Transplant Rejection
LAMBDA 002 (Lung Registry) Study
The LAMBDA 002 registry study is an observational, longitudinal, multi-center study observing patients undergoing lung transplant.
- Trial name
- NCT05170425
- Testing
- Prospera
- Where
- 11 sites in United States
- Volunteers
- 154 people
- Sponsor
- Natera, Inc.
Heart Transplant Rejection
Prospera Test Evaluation in Cardiac Transplant (ProTECT)
The ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant for whom Prospera testing is part of routine clinical care, who are enrolled within 60 days of heart…
- Trial name
- ProTECT (NCT05205551)
- Where
- United States
- Volunteers
- 411 people
- Sponsor
- Natera, Inc.
Transplant Rejection, Allograft Rejection
Study for the Prediction of Active Rejection in Organs Using Donor-derived Cell-free DNA Detection
This is a multi-center prospective study designed to collect blood samples from transplant patients in order to improve Natera's method for determining allograft rejection status using the donor-derived cell-free DNA analysis…
- Conditions
- Transplant Rejection, Allograft Rejection, Complications
- Trial name
- SPARO (NCT03984747)
- Where
- 4 sites in United States
- Volunteers
- 110 people
- Sponsor
- Natera, Inc.
Colorectal Cancer Screening
Prospective Collection of Samples to Enable the Development of Natera Screening Assay for Early Cancer Detection
The PROCEED-CRC study will prospectively collect blood samples from participants who are at average risk of colorectal cancer (CRC). Samples will be used for research use and the development of a blood-based CRC screening test.
- Trial name
- PROCEED-CRC (NCT06620627)
- Where
- United States
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Natera, Inc.
Heart Transplant
Development of Non-invasive Cell-free DNA to Supplant Invasive Biopsy in Heart Transplantation
This is a prospective, multicenter observational, unblinded, longitudinal cohort study. Subjects will be enrolled into the study prior to or at the time of heart transplantation.
- Trial name
- DEFINE-HT (NCT05309382)
- Testing
- Prospera
- Where
- 9 sites in United States
- Volunteers
- 147 people
- Sponsor
- Natera, Inc.
Twin to Twin Transfusion Syndrome, Pregnancy Complications
Clinical Utility of the Addition of a SNP-based NIPT Zygosity Determination in Twin Pregnancy Management.
The ZTWINS registry study is an observational, prospective, multi-center study observing women carrying a twin pregnancy who receive snp-based non-invasive prenatal screening and zygosity assessment as part of their medical care.
- Conditions
- Twin to Twin Transfusion Syndrome, Pregnancy Complications, Multiple Gestation; Maternal Care
- Trial name
- ZTWINS (NCT05312814)
- Where
- 8 sites in United States
- Volunteers
- 137 people
- Sponsor
- Natera, Inc.
Colorectal Cancer, Melanoma
BESPOKE Study of ctDNA Guided Immunotherapy
This is a prospective data collection study of patients with advanced solid tumors who will receive standard of care immunotherapy (IO) and will be monitored with SIGNATERA™ testing.
- Conditions
- Colorectal Cancer, Melanoma, Non-small Cell Lung Cancer
- Trial name
- NCT04761783
- Where
- United States
- Volunteers
- 290 people
- Sponsor
- Natera, Inc.
Kidney Transplant Rejection
The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)
The ProActive registry is a longitudinal, multi-center study with a prospective arm observing clinical care for patients receiving physician ordered Prospera, an allograft rejection test, and a historical control arm collecting…
- Trial name
- ProActive (NCT04091984)
- Testing
- Prospera
- Where
- 55 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- Natera, Inc.