Other Clinical Trial - Clinical Performance Evaluation of the C2i-Test

Status Terminated

Clinical Trial Summary

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 (WGS) data for detecting molecular residual disease (MRD) in patients diagnosed with muscle-invasive bladder cancer (MIBC) and histopathologically classified as stage II-IIIA. The C2i-Test is a single site assay performed in the C2i Genomics' CLIA-certified laboratory. This is a prospective non-interventional study to collect definitive evidence of the safety and effectiveness of C2i-Test for the intended use, in a statistically justified number of subjects.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Muscle-Invasive Bladder Carcinoma
Urinary Bladder Neoplasms

Clinical Trial Details

NCT number	NCT05221827
Study type	Observational
Source	C2i Genomics
Contact
Status	Terminated
Phase
Start date	February 24, 2022
Completion date	July 27, 2022

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05097404` - Clinical Utility of VI-RADS in Diagnosis of MIBC
Recruiting	`NCT05483868` - A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer	Phase 1
Not yet recruiting	`NCT04966130` - Effect of Urinary Indwelling Time on Early Continence After Robot-assisted Radical Cystectomy With Orthotopic Ileal Neobladder.
Active, not recruiting	`NCT04610671` - Study of CG0070 Combined With Nivolumab in Cisplatin Ineligible Patients With MIBC	Phase 1
Recruiting	`NCT06341400` - RC48 Combined With Toripalimab as Neoadjuvant Therapy for Cisplatin Ineligible MIBC Patients	Phase 1/Phase 2
Recruiting	`NCT06190197` - Prophylactic Antibiotics in Cystectomy With Diversion	Early Phase 1
Recruiting	`NCT05203913` - Cisplatin, Nab-paclitaxel, Nivolumab With Radiotherapy After Resection of Non-Metastatic Muscle Invasive Bladder Cancer	Phase 2
Recruiting	`NCT05790850` - Pre-Habilitation With Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)	N/A
Recruiting	`NCT05833867` - Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Muscle Invasive Bladder Cancer	Phase 1
Recruiting	`NCT05295992` - Conventionally Fractionated Adaptive Radiation Therapy of Bladder Cancer an Individualized Approach	N/A
Recruiting	`NCT06215976` - The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer	Phase 4
Recruiting	`NCT05028660` - AURORAX-0093A: Glycosaminoglycan Profiling for Prognostication of Muscle-invasive Bladder Cancer - a Pilot Study
Not yet recruiting	`NCT06417190` - Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology	Phase 2
Not yet recruiting	`NCT04909775` - Chemotherapy Combined With Tislelizumab as Bladder Sparing Option for Patients With Muscle Invasive Bladder Cancer	Phase 2
Recruiting	`NCT04876313` - An Open Label, Single-arm, Phase 2 Study of Neoadjuvant Nivolumab and Nab-paclitaxel Before Radical Cystectomy for Patients With Muscle-invasive Bladder Cancer (NURE-Combo)	Phase 2
Not yet recruiting	`NCT04686149` - a Genome-based Platform to Predict Patients That Can Achieve Bladder Preservation in Muscle Invasive Bladder Cancer Patients
Active, not recruiting	`NCT05630131` - ctDNA in Subjects With Muscle-invasive Bladder Cancer Treated With Trimodality Therapy
Recruiting	`NCT06170177` - Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy
Recruiting	`NCT06257017` - Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma: A Pilot Randomized Controlled Trial	Phase 2
Recruiting	`NCT05767528` - Clinical Study of Neoadjuvant Therapy Outcome Prediction of Muscle-invasive Bladder Cancer Based on PTC Drug Sensitivity Detection