Rectum CancerNCT04745091
MRI Split Scar Sign as a Predictor to Complete Pathologic Response After Neoadjuvant Chemoradiation in Rectal Cancer
An observational study of Rectum Cancer, run by Alexandria University.
Trial summary
Patients with middle or low rectal cancer who receive neoadjuvant chemoradiation and achieve complete clinical response while their pelvic MRI have split scar sign are included. Patients will have total mesorectal excision and pathologic complete response will be assessed Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectum Cancer
- What is being tested?
- total mesorectal excision
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: locally advance middle and low rectal cancer
Who may be able to join
- middle and low rectal cancer
Who cannot join
- Distant metastasis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Complete Clinical Response With MRI Split Scar Sign as a Predictor to Complete Pathologic Response After Neoadjuvant Chemoradiation in Rectal Cancer
Patients with middle or low rectal cancer who receive neoadjuvant chemoradiation and achieve complete clinical response while their pelvic MRI have split scar sign are included. Patients will have total mesorectal excision and pathologic complete response will be assessed
Read the detailed description
Patients with middle or low rectal cancer who have T3-4 and/ or N+ will be included. Patients will receive neoadjuvant chemoradiation in the form of pelvic irradiation by 50.4 thousands grays together with radio sensitization by 5-FU or oxaliplatin, 8 months after completion of neoadjuvant chemoradiation patients will be assessed clinically and radiologically. Complete clinical response is diagnosed if clinically no tumor is felt or just small scar and no tumor appears in MRI. Of these patients who achieve complete clinical response we will pick up cases who have split scar sign in the pelvic MRI. Patients will have total mesorectal excision 8-11 weeks after completion of neoadjuvant chemoradiation and pathologic complete response will be assessed. Correlation will be done between preoperative clinical response and postoperative pathologic response
- Conditions
- Rectum Cancer
- Being tested
- total mesorectal excision
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total mesorectal excisionProcedure or surgery
excision of the rectum with complete excision of the mesorectum
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete pathologic response
disappearance of tumor from resected specimen
Measured: after surgical excision with follow up of an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Feb 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectum CancerStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Madbouly, Alexandria University
- Investigators
- Khaled Madbouly, MD, PhD, Principal investigator, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745091
- Sponsor's protocol ID
- 0201372
- Status last verified
- Jan 2021
- First submitted
- 30 Jan 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: no approval yet from ethical committee to share data. Not written in patients' consent yet
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Clinical Response With MRI Split Scar Sign as a Predictor to Complete Pathologic Response After Neoadjuvant Chemoradiation in Rectal Cancer
- ClinicalTrials.gov ID
- NCT04745091
- Acronym / sponsor ID
- 0201372
- Conditions
- Rectum Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 9 Feb 2021 (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.
Patients with middle or low rectal cancer who receive neoadjuvant chemoradiation and achieve complete clinical response while their pelvic MRI have split scar sign are included. Patients will have total mesorectal excision and pathologic complete response will be assessed
Detailed description
Patients with middle or low rectal cancer who have T3-4 and/ or N+ will be included. Patients will receive neoadjuvant chemoradiation in the form of pelvic irradiation by 50.4 thousands grays together with radio sensitization by 5-FU or oxaliplatin, 8 months after completion of neoadjuvant chemoradiation patients will be assessed clinically and radiologically. Complete clinical response is diagnosed if clinically no tumor is felt or just small scar and no tumor appears in MRI. Of these patients who achieve complete clinical response we will pick up cases who have split scar sign in the pelvic MRI. Patients will have total mesorectal excision 8-11 weeks after completion of neoadjuvant chemoradiation and pathologic complete response will be assessed. Correlation will be done between preoperative clinical response and postoperative pathologic response
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- locally advance middle and low rectal cancer
Key inclusion criteria (1 listed)
- middle and low rectal cancer
Key exclusion criteria (1 listed)
- Distant metastasis
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 |
|---|---|---|
| total mesorectal excisionexcision of the rectum with complete excision of the mesorectum | Procedure or surgery | – |
Primary outcome
Complete pathologic response
Time frame: after surgical excision with follow up of an average of 1 year
disappearance of tumor from resected specimen
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: Undecided. no approval yet from ethical committee to share data. Not written in patients' consent yet
Related trials for Rectum Cancer
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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. This study is not recruiting at the moment.
Khaled Madbouly, MD, PhD principal investigator
University of Alexandria
Questions about this trial
What is this clinical trial studying?
An observational study of Rectum Cancer, run by Alexandria University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khaled Madbouly, MD, PhD (+2034802375, khaled.madbouly@alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete pathologic response (time frame: after surgical excision with follow up of an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2021.