Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0)

Status Completed

Clinical Trial Summary

The primary objective of this study is to assess the sensitivity for colorectal cancer (CRC) and specificity of the mt-sDNA 2.0 test.

Clinical Trial Description

Subjects 40 years of age and older scheduled for a screening colonoscopy will be enrolled. Subject will complete the mt-sDNA 2.0 test and the commercially available FIT, followed by completion of a screening colonoscopy. The results of the mt-sDNA screening test and FIT will not be provided to investigators for clinical management of the study subject. Personnel performing the colonoscopy and producing the resulting report and personnel performing histopathologial review of reports or tissue (if applicable) will remain blinded to the results of the mt-sDNA 2.0 screening test results. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04144738
Study type	Observational
Source	Exact Sciences Corporation
Contact
Status	Completed
Phase
Start date	November 15, 2019
Completion date	March 30, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05400122` - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer	Phase 1
Active, not recruiting	`NCT05551052` - CRC Detection Reliable Assessment With Blood
Completed	`NCT00098787` - Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer	Phase 2
Recruiting	`NCT06037954` - A Study of Mental Health Care in People With Cancer	N/A
Recruiting	`NCT05425940` - Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer	Phase 3
Suspended	`NCT04595604` - Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.	N/A
Completed	`NCT03414125` - Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening	N/A
Completed	`NCT02963831` - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies	Phase 1/Phase 2
Recruiting	`NCT05489211` - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)	Phase 2
Terminated	`NCT01847599` - Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib	N/A
Completed	`NCT05799976` - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure	N/A
Recruiting	`NCT03874026` - Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients	Phase 2
Active, not recruiting	`NCT03170960` - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors	Phase 1/Phase 2
Completed	`NCT03167125` - Participatory Research to Advance Colon Cancer Prevention	N/A
Completed	`NCT03181334` - The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation	N/A
Recruiting	`NCT04258137` - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study	N/A
Recruiting	`NCT05568420` - A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
Recruiting	`NCT02972541` - Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer	N/A
Completed	`NCT02876224` - Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors	Phase 1
Completed	`NCT01943500` - Collection of Blood Specimens for Circulating Tumor Cell Analysis	N/A

Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms