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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2027-06-01

Brief Summary

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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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Detailed Description

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Conditions

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Pathological Response Rate, Circulating Tumour DNA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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MeD-seq

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No