Colon CancerNCT04260139
Lymph Node Yield in Colon Cancer Resection Specimens
An observational study of Colon Cancer and Lymph Node Metastases, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, we aimed to develop a predictive model of lymph node yield in a series of colon cancer resection specimens with detailed anatomic and surgical technique data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Lymph Node Metastases
- What is being tested?
- Calculation of metric variables on the colectomy specimens.
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 1 Oct 2020
- 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: The pathology specimens from colon neoplasm resections will be prepared so that the lymph nodes will be separated according to their anatomic relationship to the vascular pedicles and to the tumor. Prior to dissection, the specimen will be measured from all colonic tumor patients.
Who may be able to join
- The surgical patients with a histologic diagnosis of colonic neoplasm, Colectomy of any type, including the right hemicolectomy, the left hemicolectomy, the sigmoid resection, segmental colon resection
Who cannot join
- rectal or rectosigmoid cancer colectomy beyond the inclusion criteria for colectomies patients younger than 18 previous colon resection emergency colon resection familial adenomatous polyposis or ulcerative colitis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bagcılar Training and Research Hospital
Istanbul
About this study
Official title: Macroscopic Evaluation of Colon Cancer Resection Specimens to Predict Metastatic Lymph Node Yield
In this study, we aimed to develop a predictive model of lymph node yield in a series of colon cancer resection specimens with detailed anatomic and surgical technique data.
Read the detailed description
Lymph node yield in colon resection specimens has been associated with the accuracy of staging and cancer outcomes. It has been proposed that the more central the mesenteric vascular ligation, the greater the nodal yield. However, the optimal number of harvested nodes is still a matter of debate. We prospectively evaluated the relation between specimen properties such as lenght, area, tumor location and pedicle length to the number of harvested nodes and rate of node positivity.
- Conditions
- Colon Cancer, Lymph Node Metastases
- Being tested
- Calculation of metric variables on the colectomy specimens.
- Keywords
- ileocolic pedicle, colon cancer, Staging
- Medical subject headings
- Colonic Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calculation of metric variables on the colectomy specimens.Procedure or surgery
Calculation of metric variables on the colectomy specimens including Lengths as mm
- Proximal colon,
- Ileum in cases with right hemicolectomy only,
- Proximal border,
- Tumor,
- Distal border,
- Total specimen,
- Vascular pedicle, the longitudinal distance between the nearest bowel wall and the end of ligated major vascular pedicle depending on the tumor's localization, 2. Colonic mesenteric area as mm2.
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymph Node Yield in Colon Cancer Resection Specimens
Count of lymph node
Measured: September 2019- November 2020
Lymph Node Yield in Colon Cancer Resection Specimens
Involvement of lymph node
Measured: September 2019-November 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start1 Sep 2019
- Primary completion1 Jul 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nadir Adnan Hacım, Bagcilar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260139
- Sponsor's protocol ID
- Beren Hacım
- Status last verified
- Nov 2020
- First submitted
- 5 Feb 2020
- Last updated
- 13 Nov 2020
- 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 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macroscopic Evaluation of Colon Cancer Resection Specimens to Predict Metastatic Lymph Node Yield
- ClinicalTrials.gov ID
- NCT04260139
- Acronym / sponsor ID
- Beren Hacım
- Conditions
- Colon Cancer, Lymph Node Metastases
- Keywords
- ileocolic pedicle, colon cancer, Staging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 7 Feb 2020 (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.
In this study, we aimed to develop a predictive model of lymph node yield in a series of colon cancer resection specimens with detailed anatomic and surgical technique data.
Detailed description
Lymph node yield in colon resection specimens has been associated with the accuracy of staging and cancer outcomes. It has been proposed that the more central the mesenteric vascular ligation, the greater the nodal yield. However, the optimal number of harvested nodes is still a matter of debate. We prospectively evaluated the relation between specimen properties such as lenght, area, tumor location and pedicle length to the number of harvested nodes and rate of node positivity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The pathology specimens from colon neoplasm resections will be prepared so that the lymph nodes will be separated according to their anatomic relationship to the vascular pedicles and to the tumor. Prior to dissection, the specimen will be measured from all colonic tumor patients.
Key inclusion criteria (1 listed)
- The surgical patients with a histologic diagnosis of colonic neoplasm, Colectomy of any type, including the right hemicolectomy, the left hemicolectomy, the sigmoid resection, segmental colon resection
Key exclusion criteria (1 listed)
- rectal or rectosigmoid cancer colectomy beyond the inclusion criteria for colectomies patients younger than 18 previous colon resection emergency colon resection familial adenomatous polyposis or ulcerative colitis
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 |
|---|---|---|
| Calculation of metric variables on the colectomy specimens.Calculation of metric variables on the colectomy specimens including Lengths as mm 1. Proximal colon, 2. Ileum in cases with right hemicolectomy only, 3. Proximal border, 4. Tumor, 5. Distal border, 6. Total specimen, 7. Vascular pedicle, the longitudinal distance between the nearest bowel wall and the end of ligated major vascular pedicle depending on the tumor's localization, 2. Colonic mesenteric area as mm2. | Procedure or surgery | – |
Primary outcome
Lymph Node Yield in Colon Cancer Resection Specimens
Time frame: September 2019- November 2020
Count of lymph node
Lymph Node Yield in Colon Cancer Resection Specimens
Time frame: September 2019-November 2020
Involvement of lymph node
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 13 Nov 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Colon Cancer and Lymph Node Metastases, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 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 13 Nov 2020. 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 Turkey (Türkiye). 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?
Lymph Node Yield in Colon Cancer Resection Specimens (time frame: September 2019- November 2020). 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 13 Nov 2020.