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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

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ClinicalTrials.gov Identifier: NCT06035471
Recruitment Status : Not yet recruiting
First Posted : September 13, 2023
Last Update Posted : September 13, 2023
Sponsor:
Information provided by (Responsible Party):
C. Verhoef, Erasmus Medical Center

Study Description
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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.


Condition or disease Intervention/treatment
Pathological Response Rate, Circulating Tumour DNA Diagnostic Test: MeD-seq

Study Design
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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Estimated Study Start Date : October 1, 2023
Estimated Primary Completion Date : June 1, 2026
Estimated Study Completion Date : June 1, 2027
Groups and Cohorts
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Intervention Details:
  • 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).

Outcome Measures
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Primary Outcome Measures :
  1. cfDNA methylation markers [ Time Frame: 4 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Locally advanced rectal cancer patients scheduled for preoperative chemoradiation
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06035471


Contacts
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Contact: David Mens, MD +31634310799 d.mens@erasmusmc.nl

Sponsors and Collaborators
Erasmus Medical Center
More Information
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Responsible Party: C. Verhoef, Professor, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT06035471    
Other Study ID Numbers: Med-Seq Rectal
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: September 13, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases