MRI Split Scar Sign as a Predictor to Complete Pathologic... | NCT04745091

Studies
MRI Split Scar Sign as a Predictor to Complete Pathologic Response After Neoadjuvant Chemoradiation in Rectal Cancer

NCT04745091

Sponsor

Alexandria University

Status

Unknown status

Last Update Posted

Feb 9, 2021Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Rectum Cancer

Interventions

total mesorectal excision

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2021Estimated

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Jun 30, 2022Estimated

First Submitted Date

Jan 30, 2021

First Submission Date that Met QC Criteria

Feb 6, 2021

First Posted Date

Feb 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2021

Last Update Posted Date

Feb 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
total mesorectal excision	Procedure	excision of the rectum with complete excision of the mesorectum

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete pathologic response	disappearance of tumor from resected specimen	after surgical excision with follow up of an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

middle and low rectal cancer

Exclusion Criteria:

Distant metastasis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

locally advance middle and low rectal cancer

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Khaled Madbouly, MD, PhD	Contact	+2034802375		khaled.madbouly@alexmed.edu.eg

Overall Officials

Name	Affiliation	Role
Khaled Madbouly, MD, PhD	University of Alexandria	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

no approval yet from ethical committee to share data. Not written in patients' consent yet

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided