Viewing Study NCT06555731



Ignite Creation Date: 2024-10-26 @ 3:37 PM
Last Modification Date: 2024-10-26 @ 3:37 PM
Study NCT ID: NCT06555731
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-08-13

Brief Title: Ultra Rapid GEnome Sequencing
Sponsor: None
Organization: None

Study Overview

Official Title: Long-read Human Genome Sequencing in 72 Hours Ultra Rapid GEnome Sequencing
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: URGES
Brief Summary: Next-generation sequencing NGS has revolutionized the field of genomics allowing the detection of genetic abnormalities for diagnostic or therapeutic purposes Turnaround times for exome or genome sequencing results have decreased to an average of 3 to 6 months

An increasing number of diagnostic and therapeutic fields are benefiting from the advancements in ultra-rapid sequencing In some situations a shorter turnaround time may be useful for making therapeutic andor interventional management decisions

This study aims to explore the feasibility of very rapid whole-genome sequencing ultra-rapid genome sequencing URGES in 72 hours that could benefit patients with cancer or rare diseases
Detailed Description: Blood sample 5 ml
Extraction of genomic DNA from lymphocytes
Ultra-rapid genome sequencing 48 hours for a whole genome using the PromethION P2 Solo sequencer Oxford Nanopore Technologies
Bioinformatics analysis of raw high-throughput sequencing data with SeqOne platform
Medical interpretation of molecular data NGS data must be interpreted by a multidisciplinary decision-support team to determine mutation actionability and identify potential drivers

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None