Ignite Creation Date:
2024-05-06 @ 2:25 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04319354
Status:
COMPLETED
Last Update Posted:
2023-05-19
First Post:
2020-03-09
Brief Title:
Evaluation of cfDNA as a Marker of Response in Rectal Cancer
Sponsor:
Hospital Pedro Hispano
Organization:
Hospital Pedro Hispano
Study Overview
Official Title:
Evaluation of cfDNA as a Marker of Response to Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A pathological complete response pCR after surgery occurs in approximately 20 of rectal cancer patients submitted to neoadjuvant chemotherapy with apparent survival benefit This group could potentially be spared the morbidity of surgery
The diversified response to neoadjuvant chemotherapy nCRT amongst tumors suggests a complex relationship between tumor biology and response possibly due to a number of genetic or molecular pathways that might regulate chemoradiosensitivity
Accumulating evidence indicated that circulating cell-free nucleic acids can be a promising biomarker of response in liquid biopsy for rectal cancer The concentration of baseline plasma cell-free DNA cfDNA appears significantly higher in responders compared to non-responders
The objective of this study is to investigate the potential role of cfDNA as a marker of pCR or partial response to nCRT as well as a marker of outcomes overall survival and disease-free survival
The investigators are conducting a prospective observational cohort non-randomized study of consecutive patients with locally advanced rectal cancer submitted to nCRT followed by surgical excision 6-12 weeks later Patients are assigned to groups according to their pathological response to nCRT A total of 20 patients with complete pathological response 50 partial response and 50 non-responders will be selected over a year and followed for another year Participants will be observed and examined during the entire course of treatment and the follow-up period
Serial analysis of cfDNA through liquid biopsies will be performed in consecutive patients at specific time points pre-nCRT post-nCRT and postoperative week 1 incorporating analysis of concentration dimension of DNA fragments of mutation frequency CIN APC p53 MSI KRAS BRAF EGFR cKIT and next-generation sequencing of tumour biopsy and surgical specimens
This study will serve as the feasibility of a larger comparative study
The diversified response to neoadjuvant chemotherapy nCRT amongst tumors suggests a complex relationship between tumor biology and response possibly due to a number of genetic or molecular pathways that might regulate chemoradiosensitivity
Accumulating evidence indicated that circulating cell-free nucleic acids can be a promising biomarker of response in liquid biopsy for rectal cancer The concentration of baseline plasma cell-free DNA cfDNA appears significantly higher in responders compared to non-responders
The objective of this study is to investigate the potential role of cfDNA as a marker of pCR or partial response to nCRT as well as a marker of outcomes overall survival and disease-free survival
The investigators are conducting a prospective observational cohort non-randomized study of consecutive patients with locally advanced rectal cancer submitted to nCRT followed by surgical excision 6-12 weeks later Patients are assigned to groups according to their pathological response to nCRT A total of 20 patients with complete pathological response 50 partial response and 50 non-responders will be selected over a year and followed for another year Participants will be observed and examined during the entire course of treatment and the follow-up period
Serial analysis of cfDNA through liquid biopsies will be performed in consecutive patients at specific time points pre-nCRT post-nCRT and postoperative week 1 incorporating analysis of concentration dimension of DNA fragments of mutation frequency CIN APC p53 MSI KRAS BRAF EGFR cKIT and next-generation sequencing of tumour biopsy and surgical specimens
This study will serve as the feasibility of a larger comparative study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None