RecurrenceNCT05221684
Lymph Node Ratio as a Predictor for Outcome in Rectal Cancer
An observational study of Recurrence, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aims to evaluate the value of the LNR as a prognostic indicator in patients with rectal cancer who offered total mesorectal excision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrence
- What is being tested?
- Lymph node harvesting
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Jun 2020to 31 Dec 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with rectal cancer TNM stage I-III Who underwent surgery with curative intent
Who may be able to join
- rectal cancer of TNM stage I-III
- underwent radical resection with curative intent
Who cannot join
- synchronous colon cancer
- synchronous gastrointestinal cancer
- underwent palliative resection
- presented with intestinal obstruction
- those lost to follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lymph Node Ratio as a Predictor for Outcome in Rectal Cancer: a Retrospective Cohort
This study aims to evaluate the value of the LNR as a prognostic indicator in patients with rectal cancer who offered total mesorectal excision.
Read the detailed description
Patients and methods Study design and setting This is a retrospective review of prospectively collected and maintained database of patients with CRC admitted in the Oncology Center of Mansoura University (OCMU), the Colorectal Surgery Unit of Mansoura University Hospitals, and the Department of General Surgery of Alexandria University.
Selection criteria Patients of either gender aged 18 years or above who presented with rectal cancer of any stage will be included in the study. We will exclude patients with patients younger than 18 years; patients with synchronous colon cancer; synchronous liver, pulmonary or bones metastasis; or synchronous gastrointestinal cancer; or patients who were lost to follow-up.
Study endpoints The primary endpoint of the study is to assess the value of lymph node ratio (LNR) on the oncological outcomes.
- Conditions
- Recurrence
- Being tested
- Lymph node harvesting
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymph node harvestingProcedure or surgery
Lymph node harvesting after radical resection for rectal cancer with curative intent
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymph node value
Value in prediction of oncological outcomes
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start9 Jun 2020
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RecurrenceStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa shalaby, MD, MSc, PhD, Mansoura University
- Investigators
- Mostafa Shalaby, Principal investigator, Mansoura Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221684
- Sponsor's protocol ID
- LN ratio in rectal cancer
- Status last verified
- Jan 2022
- First submitted
- 23 Jan 2022
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymph Node Ratio as a Predictor for Outcome in Rectal Cancer: a Retrospective Cohort
- ClinicalTrials.gov ID
- NCT05221684
- Acronym / sponsor ID
- LN ratio in rectal cancer
- Conditions
- Recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 3 Feb 2022 (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.
This study aims to evaluate the value of the LNR as a prognostic indicator in patients with rectal cancer who offered total mesorectal excision.
Detailed description
Patients and methods Study design and setting This is a retrospective review of prospectively collected and maintained database of patients with CRC admitted in the Oncology Center of Mansoura University (OCMU), the Colorectal Surgery Unit of Mansoura University Hospitals, and the Department of General Surgery of Alexandria University.
Selection criteria Patients of either gender aged 18 years or above who presented with rectal cancer of any stage will be included in the study. We will exclude patients with patients younger than 18 years; patients with synchronous colon cancer; synchronous liver, pulmonary or bones metastasis; or synchronous gastrointestinal cancer; or patients who were lost to follow-up.
Study endpoints The primary endpoint of the study is to assess the value of lymph node ratio (LNR) on the oncological outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with rectal cancer TNM stage I-III Who underwent surgery with curative intent
Key inclusion criteria (2 listed)
- rectal cancer of TNM stage I-III
- underwent radical resection with curative intent
Key exclusion criteria (5 listed)
- synchronous colon cancer
- synchronous gastrointestinal cancer
- underwent palliative resection
- presented with intestinal obstruction
- those lost to follow-up.
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 |
|---|---|---|
| Lymph node harvestingLymph node harvesting after radical resection for rectal cancer with curative intent | Procedure or surgery | – |
Primary outcome
Lymph node value
Time frame: one year
Value in prediction of oncological outcomes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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.
Mostafa Shalaby principal investigator
Mansoura Faculty of Medicine
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 Recurrence, 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 2 inclusion and 5 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 3 Feb 2022. 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?
Results are not available in the source record.
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?
Lymph node value (time frame: one 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 3 Feb 2022; AzTrials last refreshed its copy on 4 Nov 2026.