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OpenTrials
Not Yet Recruiting

NCT Number: 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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MeD-seq

Diagnostic Test

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

Primary outcomes

  1. cfDNA methylation markers

    Time frame: 4 years

Study contacts

Contact information is provided by the study sponsor or research team.

David Mens, MD

CONTACT

[email protected]

+31634310799

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Sep 13, 2023
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.