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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

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06035471
Enrollment
75
Registered
2023-09-13
Start date
2023-10-01
Completion date
2027-06-01
Last updated
2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pathological Response Rate, Circulating Tumour DNA

Brief 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.

Interventions

DIAGNOSTIC_TESTMeD-seq

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

Sponsors

Erasmus Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥18 years * Histologically confirmed rectal adenocarcinoma * Scheduled for neoadjuvant chemoradiation * Written informed consent.

Exclusion criteria

* Scheduled to another neoadjuvant schedule that comprises systemic chemotherapy or short-course radiation * Not able to read or understand Dutch language or mentally not capable.

Design outcomes

Primary

MeasureTime frame
cfDNA methylation markers4 years

Contacts

Primary ContactDavid Mens, MD
d.mens@erasmusmc.nl+31634310799

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026