- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05607186
Outcomes of Neoadjuvant Therapy for Rectal Cancer in a Tertiary Asian Institute
October 31, 2022 updated by: Singapore General Hospital
Outcomes of Neoadjuvant Therapy for Rectal Cancer in a Tertiary Asian
This is a retrospective cohort study that aims to evaluate the correlation of magnetic resonance tumour regression grade (mrTRG) and pathological TRG (pTRG) of locally advanced rectal cancer after neoadjuvant long course chemoradiotherapy as well as the prognostic value of mrTRG on survival.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
59
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with locally advanced rectal cancer were recruited from the Department of Colorectal Surgery, Singapore General Hospital
Description
Inclusion Criteria:
- Rectal cancer
- At least 1 high risk feature on MRI
- Undergo long course neoadjuvant chemoradiotherapy (LCCRT)
Exclusion Criteria:
- metastatic disease
- Patients who undergo short course radiotherapy
- Patients without a repeat MRI after completion of LCCRT
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Correlation between mrTRG and pTRG
Time Frame: Between 1 Jan 2011 to 31 Dec 2016
|
Between 1 Jan 2011 to 31 Dec 2016
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Prognostic value of mrTRG on survival outcomes of rectal cancer patients
Time Frame: Between 1 Jan 2011 to 31 Dec 2016
|
Between 1 Jan 2011 to 31 Dec 2016
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2011
Primary Completion (Actual)
December 31, 2016
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
October 31, 2022
First Submitted That Met QC Criteria
October 31, 2022
First Posted (Actual)
November 7, 2022
Study Record Updates
Last Update Posted (Actual)
November 7, 2022
Last Update Submitted That Met QC Criteria
October 31, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/2342
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.