Clinical trials: Molecular Residual Disease
TNBC - Triple-Negative Breast Cancer, Minimal Residual Disease
CtDNA Based MRD Testing for NAC Monitoring in TNBC
A prospective, multicenter, observational study to evaluate the correlation of Molecular Residual Disease (MRD) detection using circulating tumor DNA guided test to pathological complete response (pCR) after neoadjuvant…
- Trial name
- B-STRONGER-I (NCT06230185)
- Where
- 14 sites in United States
- Volunteers
- 422 people
- Sponsor
- Personalis Inc.
Leukemia, Leukemia, Myeloid
Natural Killer Cell (CYNK-001) Infusions in Adults with AML
This study will find the maximum tolerated dose or the maximum planned dose of CYNK-001 which contains natural killer (NK) cells derived from human placental CD34+ cells and culture-expanded.
- Conditions
- Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Neoplasms by Histologic Type
- Trial name
- CYNK001AML01 (NCT04310592)
- Testing
- CYNK-001
- Where
- 10 sites in United States
- Volunteers
- 27 people
- Sponsor
- Celularity Incorporated
Pancreatic Cancer
Multicenter Study of Circulating Tumor DNA in Patients With Pancreatic Cancer Using a Personalized Panel
This is a multicenter, prospective, observational study to evaluate the utility of the Invitae Personalized Cancer MonitoringTM assay for patients with resectable and unresectable pancreatic cancer.
- Trial name
- ARTEMIS-PC (NCT06043921)
- Testing
- No intervention
- Where
- Japan
- Volunteers
- 150 people
- Sponsor
- Invitae Corporation
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.
Breast Cancer
EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD)
The EXActDNA-003 study will prospectively enroll participants who are planning to undergo chemotherapy for high-risk, early breast cancer, who are willing to provide tissue and blood specimens for circulating tumor DNA (ctDNA)…
- Trial name
- NCT06401421
- Testing
- ctDNA MRD test
- Where
- 58 sites in United States, Canada
- Volunteers
- 1,800 people
- Sponsor
- Exact Sciences Corporation
Colorectal Cancer
Zanzalintinib Alone or in Combination With Pembrolizumab and Berahyaluronidase Alfa in Participants With Colorectal Cancer With Molecular Residual Disease
The primary objective of this study is to evaluate the effectiveness of zanzalintinib + Pembrolizumab (+) berahyaluronidase alfa and zanzalintinib alone compared with placebo.
- Trial name
- STELLAR-316 (NCT07750158)
- Testing
- Zanzalintinib, Pembrolizumab (+) Berahyaluronidase alfa
- Where
- 13 sites in United States
- Volunteers
- 600 people
- Sponsor
- Exelixis
Muscle-Invasive Bladder Carcinoma
Clinical Performance Evaluation of the C2i-Test
The C2i-WGS-MRD Test (hereinafter referred to as C2i-Test), a personalized molecular circulating tumor DNA (ctDNA) test, is an in vitro qualitative test that uses next generation sequencing (NGS) based whole-genome sequencing…
- Trial name
- NCT05221827
- Testing
- C2i Test
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- C2i Genomics
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.
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.
Muscle Invasive Bladder Urothelial Carcinoma, Esophageal Cancer
Pan-tumor MRD Study
The purpose of this observational study is to collect clinical information, blood, and tumor tissue samples from participants diagnosed with stage I, stage II, or operable stage III cancer in select solid tumors.
- Conditions
- Muscle Invasive Bladder Urothelial Carcinoma, Esophageal Cancer, Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma, Melanoma (Skin Cancer)
- Trial name
- NCT06605404
- Testing
- blood and tissue samples
- Where
- 47 sites in United States
- Volunteers
- 1,350 people
- Sponsor
- Paradigm Health
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.