Pathological Response Rate, Circulating Tumour DNANCT06035471
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
An observational study of Pathological Response Rate, Circulating Tumour DNA, run by Erasmus Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pathological Response Rate, Circulating Tumour DNA
- What is being tested?
- MeD-seq
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Locally advanced rectal cancer patients scheduled for preoperative chemoradiation
Who may be able to join
- Age ≥18 years
- Histologically confirmed rectal adenocarcinoma
- Scheduled for neoadjuvant chemoradiation
- Written informed consent.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this 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.
- Being tested
- MeD-seq
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeD-seqDiagnostic test
MeD-seq analyse: DNA treatment bisulfite --> unmethylated C-nucleotide trabsformed in uracil.--> PCR --> next generation sequencing (NGS) --> localization methylated nucleotides (enzym LpnPI).
What is being measured
The primary outcome is the main question the study is designed to answer.
cfDNA methylation markers
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pathological Response Rate, Circulating Tumour DNAStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, C. Verhoef, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035471
- Sponsor's protocol ID
- Med-Seq Rectal
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 38049783
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06035471
- Acronym / sponsor ID
- Med-Seq Rectal
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Locally advanced rectal cancer patients scheduled for preoperative chemoradiation
Key inclusion criteria (4 listed)
- Age ≥18 years
- Histologically confirmed rectal adenocarcinoma
- Scheduled for neoadjuvant chemoradiation
- Written informed consent.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeD-seqMeD-seq analyse: DNA treatment bisulfite --> unmethylated C-nucleotide trabsformed in uracil.--> PCR --> next generation sequencing (NGS) --> localization methylated nucleotides (enzym LpnPI). | Diagnostic test | – |
Primary outcome
cfDNA methylation markers
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Derived from this study: PubMed 38049783Mens 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Pathological Response Rate, Circulating Tumour DNA, run by Erasmus Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Mens, MD (+31634310799, d.mens@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cfDNA methylation markers (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06035471, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.