MRI Split Scar Sign as a Predictor to Complete Pathologic Response After Neoadjuvant Chemoradiation in Rectal Cancer
Complete Clinical Response With MRI Split Scar Sign as a Predictor to Complete Pathologic Response After Neoadjuvant Chemoradiation in Rectal Cancer
1 other identifier
observational
20
0 countries
N/A
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2021
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedFirst Posted
Study publicly available on registry
February 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedFebruary 9, 2021
January 1, 2021
11 months
January 30, 2021
February 6, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Complete pathologic response
disappearance of tumor from resected specimen
after surgical excision with follow up of an average of 1 year
Interventions
excision of the rectum with complete excision of the mesorectum
Eligibility Criteria
locally advance middle and low rectal cancer
You may qualify if:
- middle and low rectal cancer
You may not qualify if:
- Distant metastasis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
rectal cancer specimens
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Khaled Madbouly, MD, PhD
University of Alexandria
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Surgery
Study Record Dates
First Submitted
January 30, 2021
First Posted
February 9, 2021
Study Start
February 1, 2021
Primary Completion
December 31, 2021
Study Completion
June 30, 2022
Last Updated
February 9, 2021
Record last verified: 2021-01