Clinical Trials Logo

Clinical Trial Summary

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 chemotherapy (NAC) in stage I-III triple negative breast cancer (TNBC). Results from this study aim to improve MRD detection and disease outcomes for future patients.


Clinical Trial Description

NeXT Personal CTA (Clinical Trial Assay) is a patient-specific, tumor-informed device which allows for detection of MRD from cfDNA. By using next generation sequencing technology, whole genome sequencing (WGS) is conducted from DNA derived from patient tumor and normal samples. A tumor informed personalized panel is then constructed that uses only a selection of DNA targets from the WGS by applying bioinformatic filters. The targeted personalized panel is then sequenced using NGS and DNA derived from cfDNA from plasma samples. The data from the cfDNA NGS are then further analyzed using bioinformatics filters to report the MRD status. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06230185
Study type Observational
Source Personalis Inc.
Contact Ruth Stone
Phone 518 669 9232
Email restone@criteriuminc.com
Status Recruiting
Phase
Start date November 9, 2023
Completion date December 31, 2025

See also
  Status Clinical Trial Phase
Terminated NCT04044560 - Blinatumomab for MRD in Pre-B ALL Patients Following Stem Cell Transplant Phase 2
Recruiting NCT05959720 - Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil
Recruiting NCT03665480 - The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML Phase 2/Phase 3
Active, not recruiting NCT02458014 - Blinatumomab in Treating Patients With B-cell Acute Lymphoblastic Leukemia With Minimal Residual Disease Phase 2
Active, not recruiting NCT03233854 - CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells With or Without NKTR-255 in Adults With Recurrent or Refractory B Cell Malignancies Phase 1
Active, not recruiting NCT04853017 - A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors Phase 1
Not yet recruiting NCT06358430 - Dose Escalation and Expansion Study of TROP2 CAR Engineered IL-15- Transduced Cord Blood-derived NK Cells in Combination With Cetuximab in Patient With Colorectal Cancer (CRC) With Minimal Residual Disease (MRD) Phase 1
Not yet recruiting NCT05603156 - A Study of Olverembatinib Combined With Inotuzumab Ozogamicin in the Treatment ph+ ALL With MRD Persistent Positive N/A
Withdrawn NCT03699384 - Safety and Clinical Activity Study of Combination Azacitidine and Avelumab in Patients With Acute Myeloid Leukemia (AML) and Minimal Residual Disease (MRD) Phase 1/Phase 2
Recruiting NCT05601830 - Natural Killer(NK) Cell Therapy for AML Minimal Residual Disease Phase 1
Recruiting NCT06066905 - A Study of Chidamide With AZA in MRD Positive AML After Transplant N/A
Terminated NCT03272633 - Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies Early Phase 1
Recruiting NCT03241940 - Phase I Dose Escalation Study of CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies Phase 1
Completed NCT03096782 - Umbilical Cord Blood Transplant With Added Sugar and Chemotherapy and Radiation Therapy in Treating Patients With Leukemia or Lymphoma Phase 2
Completed NCT05093192 - Mobilising Tumour and Immune Cells Via Exercise in Chronic Lymphocytic Leukaemia N/A
Recruiting NCT02400827 - Contamination of Ovarian Tissue by RT-PCR in Participants With Solid Tumors N/A
Recruiting NCT02400970 - Contamination of Testicle Tissue by RT-PCR in Participants With Solid Tumors N/A
Active, not recruiting NCT01894477 - Treo/Flu/TBI With Donor Stem Cell Transplant for Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Phase 2
Active, not recruiting NCT04920188 - Development and Application of a Novel Digital Array PCR for Acute Myeloid Leukemia (AML)
Completed NCT02714790 - Prognostic Role of Minimal Residual Disease in Acute Myeloid Leukemia N/A