NCT06035471

Can we Use a Simple Blood Test to Reduce Unnecessary Adverse Effects From Radiotherapy by Timely Identification of Radiotherapy-resistant Rectal Cancers? MeD-Seq Rectal Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Chemoradiation therapy (CRT) followed by surgery is currently the standard of care to treat patients with locally advanced rectal cancer (LARC). CRT reduces local recurrences, but is associated with significant damage to the surrounding healthy tissue that can severely impact quality of life. Additionally, a proportion of patients (hardly) benefit from CRT. We aim to develop a diagnostic innovation, which can enable a more selective and thereby more effective use of the available therapies for rectal cancer patients. The objective of this study is to investigate whether patients can be identified who will response to CRT prior to start of the CRT in rectal cancer and therefore avoid possible severe side effects in patients who will not reponse on CRT.

Conditions

• Pathological Response Rate, Circulating Tumour DNA

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MeD-seq	MeD-seq analyse: DNA treatment bisulfite --\> unmethylated C-nucleotide trabsformed in uracil.--\> PCR --\> next generation sequencing (NGS) --\> localization methylated nucleotides (enzym LpnPI).

Timeline

• Start date: 2023-10-01
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2023-09-13
• Last updated: 2023-09-13