Rectal CancerNCT05078515
Multicenter Validation of the PREDICT Score
An observational study of Rectal Cancer, run by Mansoura University at 1 site in Egypt.
Trial summary
Even after adequate TME with grade III mesorectal grading, local recurrence remains a possible event. Several studies investigated different parameters and assessed their predictive power in regards to local recurrence after TME. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- PREDICT score
- How many people
- 262 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2008to 1 Aug 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage I-III rectal cancer who underwent surgery with curative intent
Who may be able to join
- Adult patients of either sex with non-metastatic low or middle rectal cancer who underwent elective TME with curative intent
Who cannot join
- Patients with recurrent or metastatic rectal cancer at the time of presentation
- Patients with synchronous colon cancer
- Patients with missing data on the outcome of TME.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura university hospital
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Multicenter Validation of the PREDICT Score for Prediction of Local Recurrence After Total Mesorectal Excision of Rectal Cancer
Even after adequate TME with grade III mesorectal grading, local recurrence remains a possible event. Several studies investigated different parameters and assessed their predictive power in regards to local recurrence after TME. These parameters included a variety of patient-related, tumor-related, and treatment-related factors. A recent meta-analysis reviewed the current literature for the predictors of local recurrence after TME for rectal cancer and developed a prognostic scoring system, the PREDICT score.
The present study aimed to validate the PREDICT scoring system by applying it to a prospective cohort of patients with rectal cancer who underwent curative TME in three
- Conditions
- Rectal Cancer
- Being tested
- PREDICT score
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREDICT scoreDiagnostic test
Predictive score for local recurrence after TME for rectal cancer that includes 8 parameters
| Study group | Role | What they receive |
|---|---|---|
| Patients with recurrence after TME | Patients who developed local recurrence after TME of rectal cancer Receives: Diagnostic Test: PREDICT score | |
| Patients without recurrence after TME | Patients who did not develop local recurrence after TME of rectal cancer Receives: Diagnostic Test: PREDICT score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of PREDICT score
The ability of the score to predict actual cases of recurrence after TME
Measured: 36 months after surgery
Specificity of PREDICT score
The ability of the score to predict patients who did not experience recurrence after TME
Measured: 36 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start1 Jan 2008
- Primary completion31 Dec 2018
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Emile, Mansoura University
- Investigators
- Sameh H Emile, M.D., FACS, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078515
- Sponsor's protocol ID
- Mansoura2020110
- Status last verified
- Oct 2021
- First submitted
- 2 Oct 2021
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Validation of the PREDICT Score for Prediction of Local Recurrence After Total Mesorectal Excision of Rectal Cancer
- ClinicalTrials.gov ID
- NCT05078515
- Acronym / sponsor ID
- Mansoura2020110
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 14 Oct 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.
Even after adequate TME with grade III mesorectal grading, local recurrence remains a possible event. Several studies investigated different parameters and assessed their predictive power in regards to local recurrence after TME. These parameters included a variety of patient-related, tumor-related, and treatment-related factors. A recent meta-analysis reviewed the current literature for the predictors of local recurrence after TME for rectal cancer and developed a prognostic scoring system, the PREDICT score.
The present study aimed to validate the PREDICT scoring system by applying it to a prospective cohort of patients with rectal cancer who underwent curative TME in three
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with recurrence after TME | – | Diagnostic Test: PREDICT scorePatients who developed local recurrence after TME of rectal cancer |
| Patients without recurrence after TME | – | Diagnostic Test: PREDICT scorePatients who did not develop local recurrence after TME of rectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage I-III rectal cancer who underwent surgery with curative intent
Key inclusion criteria (1 listed)
- Adult patients of either sex with non-metastatic low or middle rectal cancer who underwent elective TME with curative intent
Key exclusion criteria (3 listed)
- Patients with recurrent or metastatic rectal cancer at the time of presentation
- Patients with synchronous colon cancer
- Patients with missing data on the outcome of TME.
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 |
|---|---|---|
| PREDICT scorePredictive score for local recurrence after TME for rectal cancer that includes 8 parameters | Diagnostic test | Patients with recurrence after TME, Patients without recurrence after TME |
Primary outcome
Sensitivity of PREDICT score
Time frame: 36 months after surgery
The ability of the score to predict actual cases of recurrence after TME
Specificity of PREDICT score
Time frame: 36 months after surgery
The ability of the score to predict patients who did not experience recurrence after TME
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Sameh H Emile, M.D., FACS principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Mansoura University at 1 site in Egypt.
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 3 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: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of PREDICT score (time frame: 36 months after surgery). The study lists 2 primary outcomes in all. 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 14 Oct 2021.