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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MeD-seq.
- Who it may be relevant to
- Registry conditions: Pathological Response Rate, Circulating Tumour DNA. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 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).
Primary outcome measures
- cfDNA methylation markers [Time frame: 4 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Mens DM, van Rees JM, Wilting SM, Verhoef C. 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 protocol. BMC Cancer. 2023 Dec 4;23(1):1187. doi: 10.1186/s12885-023-11671-y. PMID 38049783
Identifiers
NCT: NCT06035471 · Med-Seq Rectal