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

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

Tracking Information

• First Submitted Date: September 6, 2023
• First Posted Date: September 13, 2023
• Last Update Posted Date: September 13, 2023
• Estimated Study Start Date: October 1, 2023
• Estimated Primary Completion Date: June 1, 2026 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 6, 2023): cfDNA methylation markers [ Time Frame: 4 years ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief 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
• 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

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Locally advanced rectal cancer patients scheduled for preoperative chemoradiation
• Condition: Pathological Response Rate, Circulating Tumour DNA

Intervention

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).

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: September 6, 2023): 75
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 1, 2027
• Estimated Primary Completion Date: June 1, 2026 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06035471
• Other Study ID Numbers: Med-Seq Rectal
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: C. Verhoef, Erasmus Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Erasmus Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Erasmus Medical Center
• Verification Date: September 2023