Ignite Creation Date:
2025-12-18 @ 8:36 AM
Ignite Modification Date:
2025-12-18 @ 8:36 AM
Study NCT ID:
NCT05356585
Status:
None
Last Update Posted:
2024-04-12 00:00:00
First Post:
2022-04-27 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Circulating Tumor DNA to Monitor the Efficacy of Total Neoadjuvant Therapy for Rectal Cancer
Sponsor:
None
Organization:
Study Overview
Official Title:
Circulating Tumor DNA to Monitor the Efficacy of Total Neoadjuvant Therapy for Rectal Cancer
Status:
None
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor already published research that was to be obtained from this study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rectal cancer tissue samples that were collected from participants' previous biopsies will be sent to Natera for Signatera assay creation after enrollment onto the study.
One 6 mL tube of blood will be obtained at baseline prior to initiation of treatment. Blood will also be obtained in two 6 tubes at the following points: 3-4 weeks into chemoradiation therapy (CRT), after CRT, after chemotherapy, after surgery for those who undergo resection, and during surveillance 3 months after surgery or at the end of treatment for one year after completion of TNT (total neoadjuvant therapy).
The primary objective of the study is to estimate the percentage of patients with positive ctDNA at the end of TNT .
The secondary objectives of the study include:
1. Estimating the change in ctDNA after chemoradiation and chemotherapy
2. Characterize the correlation of complete response to TNT with presence or absence of ctDNA
3. Describe the recurrence rate in participants with and without ctDNA after TNT
4. Characterize the correlation of ctDNA at end of TNT with recurrence free survival at 2 years.
One 6 mL tube of blood will be obtained at baseline prior to initiation of treatment. Blood will also be obtained in two 6 tubes at the following points: 3-4 weeks into chemoradiation therapy (CRT), after CRT, after chemotherapy, after surgery for those who undergo resection, and during surveillance 3 months after surgery or at the end of treatment for one year after completion of TNT (total neoadjuvant therapy).
The primary objective of the study is to estimate the percentage of patients with positive ctDNA at the end of TNT .
The secondary objectives of the study include:
1. Estimating the change in ctDNA after chemoradiation and chemotherapy
2. Characterize the correlation of complete response to TNT with presence or absence of ctDNA
3. Describe the recurrence rate in participants with and without ctDNA after TNT
4. Characterize the correlation of ctDNA at end of TNT with recurrence free survival at 2 years.
Detailed Description:
None
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?: