Clinical trials: sponsored by Natera, Inc.
Early and Locally Advanced Breast Cancer
ABCSG 61 / TEODOR : Neoadjuvant TrEatment Optimization Driven by Circulating Tumor DNA and endOcrine Responsiveness
The goal of this performance study is to learn if treatment with neoadjuvant endocrine therapy compared to chemotherapy has comparable efficacy, but better quality of life outcomes in endocrine responsive participants with early…
- Trial name
- TEODOR (NCT07084558)
- Testing
- blood sample for Signatera (TM) test, biopsy for Ki-67 assessment, FFPE tumor sample for Signatera (TM) test (archived)
- Where
- 14 sites in Austria
- Volunteers
- 350 people
- Sponsor
- Austrian Breast & Colorectal Cancer Study Group
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.
Colorectal Cancer
Personalizing Chemotherapy Selection After Surgery for Patients With Stage III Colorectal Cancer Using a Blood Test
CIRCULATE-III is an international, multicenter, open-label, randomized phase III trial designed to use ctDNA as a selection criterion for intensification or de-escalation of adjuvant chemotherapy.
- Trial name
- CIRCULATEIII (NCT07340567)
- Testing
- Capecitabine, Oxaliplatin, Folfirinox
- Where
- 5 sites in France, Sweden
- Volunteers
- 2,450 people
- Sponsor
- UNICANCER
Metastatic Invasive Breast Cancer
Rising ctDNA to Tailor Endocrine Therapy Switch in Patients With ER+/HER2- Metastatic Breast Cancer.
Rationale: In patients with metastatic breast cancer, fragments of tumor DNA called "circulating tumor DNA" or "ctDNA" can be detected in the blood.
- Trial name
- TAILORswitch (NCT07717450)
- Testing
- Tumor assessment, Completion of Quality-of-life questionnaires, ECG
- Volunteers
- 370 people
- Sponsor
- UNICANCER
Metastatic Breast Cancer, HER2-positive Breast Cancer
Decreasing Treatment for Metastatic HER2-Positive Breast Cancer With Undectable Cancer Levels in Blood Tests.
Heroes is a multicentre, national, non-randomized, open-label, phase 2 study. The goal of this clinical trial is to evaluate the feasibility of therapeutic de-escalation in HER2-positive metastatic breast cancer with disease…
- Trial name
- HEROES (NCT06450314)
- Testing
- Discontinuation of the anti-HER2 maintenance therapy, Monitoring with signatera test
- Where
- France
- Volunteers
- 170 people
- Sponsor
- UNICANCER
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.
Germ Cell Cancer Metastatic
Circulating Tumor DNA in Stage I, II, and III Germ-Cell Tumors
This study will evaluate the utility of ctDNA detection in patients with high-risk stage I, stage II, and stage III germ cell tumor disease to develop a tool for post-treatment cancer cell detection.
- Trial name
- NCT07401316
- Testing
- Whole blood for ctDNA
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Indiana University
Cancer of the Rectum
The Surveillance Nonoperative Watch & Wait (SNOWW) Rectal Cancer Trial.
The primary objectives of this study are to determine if the inclusion of ctDNA testing in the evaluation and management of stages 2 and 3 rectal cancers will allow clinicians to improve their selection of patients for wait and…
- Trial name
- SNOWW (NCT07292285)
- Sponsor
- University of Colorado, Denver
Kidney Transplant Rejection
Trifecta-Kidney cfDNA-MMDx Study
Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood, and the Molecular Microscope® (MMDx) Diagnostic System results in indication biopsies.
- Trial name
- NCT04239703
- Testing
- MMDx, Prospera, HLA antibody
- Where
- 31 sites in United States, Australia and 8 more
- Volunteers
- 300 people
- Sponsor
- University of Alberta
Colon Adenocarcinoma, Colorectal Cancer
Study of ctDNA Guided Change in Tx for Refractory Minimal Residual Disease in Colon Adenocarcinomas
This is a phase 1b, prospective, single arm, non-randomized, open-label clinical trial determining the efficacy of adjuvant trifluridine and tipiracil (TAS-102) in combination with irinotecan in patients with ctDNA positive colon…
- Trial name
- NCT04920032
- Testing
- TAS-102, Irinotecan, Standard Treatment
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- University of California, Irvine
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.
Rectal Adenocarcinoma
Adaptive Radiation for Locally Advanced Rectal Adenocarcinoma
The purpose of the study is to determine the feasibility of using magnetic resonance imaging (MRI)-guided adaptive chemoradiation therapy to improve response to treatment.
- Trial name
- NCT05108428
- Testing
- Capecitabine, Radiation Therapy, FOLFOX regimen
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
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.
Urothelial Carcinoma
Circulating Tumor DNA Response In Urothelial Cancer
The purpose of this clinical trial is to evaluate the effectiveness of pembrolizumab monotherapy following 24 weeks of frontline pembrolizumab \& Enfortumab Vedotin (PEV) in patients with metastatic urothelial cancer (mUC).
- Trial name
- NCT07183319
- Testing
- Pembrolizumab & Enfortumab Vedotin (PEV), Pembrolizumab
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Oklahoma
Carcinoma, Hepatocellular, Liver Cell Carcinoma
Tislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular Carcinoma
The investigators hypothesize that the addition of Tislelizumab after definitive local therapy for locally advanced inoperable Hepatocellular carcinoma (HCC) will synergize with local therapy as well as treat micro metastatic…
- Trial name
- NCT05366829
- Testing
- Tislelizumab
- Where
- 2 sites in United States
- Volunteers
- 35 people
- Sponsor
- Rutgers, The State University of New Jersey
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.