Evaluation of cfDNA as a Marker of Response in Rectal Cancer

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04319354
Study type	Interventional
Source	Hospital Pedro Hispano
Contact
Status	Completed
Phase	N/A
Start date	November 18, 2019
Completion date	December 30, 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04160650` - Educational Nursing Intervention Among Patients With Colorectal Cancer During Chemotherapy	N/A
Recruiting	`NCT02948348` - Study to Nivolumab Following Preoperative Chemoradiotherapy	Phase 1/Phase 2
Recruiting	`NCT01403883` - Psychological and Enterostomal Therapy Care	N/A
Recruiting	`NCT05179824` - Tempus Priority Study: A Pan-tumor Observational Study
Completed	`NCT04716010` - Developing and Evaluating Product Messaging	N/A
Completed	`NCT02641691` - Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum	Phase 2
Recruiting	`NCT03573791` - Biomarkers for Predicting Neoadjuvant Chemoradio-resistance for Middle-low Advanced Rectal Cancer
Recruiting	`NCT04456283` - Survival of Patients With a Reduction in the Number of Lymph Nodes in Rectal Cancer After Neoadjuvant Chemoradiotherapy
Recruiting	`NCT05358704` - Preoperative ChemoRadiation And FOLFOXIRI for Rectal Cancer (CRAFTER) for Rectal Cancer	Phase 2
Not yet recruiting	`NCT03910283` - Leveraging Mindsets to Improve Health & Wellbeing in Patients With Cancer	N/A
Recruiting	`NCT03896958` - The PIONEER Initiative: Precision Insights On N-of-1 Ex Vivo Effectiveness Research Based on Individual Tumor Ownership (Precision Oncology)
Recruiting	`NCT05887531` - Abdominopelvic Cancer Prehabilitation	N/A
Completed	`NCT04880772` - Clinical Trial Comparing Standard Care Versus Prehabilitation in Patients Undergoing Cancer Surgery	N/A
Completed	`NCT00271986` - Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection (LAR) for Recto-sigmoid Cancer	N/A
Recruiting	`NCT04095299` - Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy in Rectal Cancer Patients	Phase 2
Active, not recruiting	`NCT06181201` - Association Between the Composition of the Intestinal Microbiota and Tumor Response in Locally Advanced Rectal Cancer
Not yet recruiting	`NCT03607643` - A Study of the Efficacy of Cannabidiol in Patients With Multiple Myeloma, Glioblastoma Multiforme, and GI Malignancies	Phase 1/Phase 2
Terminated	`NCT04812743` - Colorectal Health Research Champions	N/A
Recruiting	`NCT03452774` - SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
Recruiting	`NCT05732389` - Immunotherapy in Patients With Early dMMR Rectal Cancer	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.