Extranodal ExtensionTDNCT05923450
Tumor Deposits in Colorectal Cancers
An observational study of Extranodal Extension, run by University of Campania Luigi Vanvitelli.
Trial summary
Tumor deposits (TDs) are emerging as an adverse prognostic factor in colorectal cancers (CRCs), but they are quite ignored in the current staging system. Previous proposals to incorporate TDs in node stage or consider them distant metastases raised some doubt. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Extranodal Extension
- What is being tested?
- Colorectal Resection
- Type of treatment
- Surgery or procedure
- How many people
- 243 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 31 Mar 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: colorectal cancer patients with metastatic nodes undergoing radical surgery and adjuvant chemotherapy
Who may be able to join
- colorectal cancers in stage III TNM undergoing radical surgery and adjuvant chemotherapy
Who cannot join
- Lynch syndrome
- Rectal Cancer undergoing neoadjuvant (radio)chemotherapy
- colorectal cancers without metastatic nodes
- metastatic colorectal cancers
- eligible patients refusing adjuvant chemotherapy
About this study
Official title: Presence of Tumor Deposits is a Strong Indicator of Poor Outcome in Stage III Colorectal Cancers Undergoing Radical Surgery: Need for an Urgent Revision of the Staging System
Tumor deposits (TDs) are emerging as an adverse prognostic factor in colorectal cancers (CRCs), but they are quite ignored in the current staging system. Previous proposals to incorporate TDs in node stage or consider them distant metastases raised some doubt. The Authors propose a new staging system to optimize treatments.
Read the detailed description
Tumor deposits (TDs) are emerging as an adverse prognostic factor in colorectal cancers (CRCs).In the current staging system TDs are somewhat neglected.
It has been proposed to add TD count to the number of metastatic lymph nodes or to consider TDs as distant metastases, but the scientific basis of these proposals seems dubious and not supported by robust statistical analyses.
The investigators supposed that splitting the three sub-stages of the stage III CRC according to absence or presence of TDs could be an easy and useful method to avoid the loss of crucial information. The proposed study will include 243 stage III CRC patients undergoing radical surgery and adjuvant chemotherapy. Each new substage, according to absence or presence of tumor deposits, will be analyzed with sophisticated statistical analysis (particularly the area-under-curve (AUC), calculated by the time-dependent receiver-operating-characteristic (ROC) curve for censored survival data) to individuate if this new staging does better the current one.
- Conditions
- Extranodal Extension
- Being tested
- Colorectal Resection
- Keywords
- tumor deposits, colorectal cancers, TNM staging system, ROC Curve
- Medical subject headings
- Extranodal Extension, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorectal ResectionProcedure or surgery
Radical resection of colorectal cancer
| Study group | Role | What they receive |
|---|---|---|
| Tumor Deposits | Colorectal cancers with and without tumor deposits, undergoing curative surgery and adjuvant chemotherapy Receives: Procedure: Colorectal Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
1 to 5 years overall survival
Measured: 5 years
Disease-free Survival
1 to 5 years disease-free survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start1 Jan 2012
- Primary completion31 Dec 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Extranodal ExtensionStudies 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
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gennaro Galizia, University of Campania Luigi Vanvitelli
- Investigators
- Gennaro Galizia, MD, Principal investigator, University of Campania 'Luigi Vanvitelli'
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923450
- Sponsor's protocol ID
- Vanvitelli Naples
- Acronym
- TD
- Status last verified
- Jun 2023
- First submitted
- 20 Jun 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all data will be shared after publication
Publications
Galizia G, Lieto E, Auricchio A, Cardella F, Mabilia A, Podzemny V, Castellano P, Orditura M, Napolitano V. Naples Prognostic Score, Based on Nutritional and Inflammatory Status, is an Independent Predictor of Long-term Outcome in Patients Undergoing Surgery for Colorectal Cancer. Dis Colon Rectum. 2017 Dec;60(12):1273-1284. doi: 10.1097/DCR.0000000000000961.
PubMed 29112563Cervantes A, Adam R, Rosello S, Arnold D, Normanno N, Taieb J, Seligmann J, De Baere T, Osterlund P, Yoshino T, Martinelli E; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Metastatic colorectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Jan;34(1):10-32. doi: 10.1016/j.annonc.2022.10.003. Epub 2022 Oct 25. No abstract available.
PubMed 36307056Pyo DH, Kim SH, Ha SY, Yun SH, Cho YB, Huh JW, Park YA, Shin JK, Lee WY, Kim HC. Revised Nodal Staging Integrating Tumor Deposit Counts With Positive Lymph Nodes in Patients With Stage III Colon Cancer. Ann Surg. 2023 Apr 1;277(4):e825-e831. doi: 10.1097/SLA.0000000000005355. Epub 2021 Dec 23.
PubMed 34954753Khan H, Radomski SN, Siddiqi A, Zhou N, Paneitz DC, Johnston FM, Greer JB. Tumor deposits are associated with a higher risk of peritoneal disease in non-metastatic colorectal cancer patients. J Surg Oncol. 2023 May;127(6):975-982. doi: 10.1002/jso.27207. Epub 2023 Feb 15.
PubMed 36790093Lieto E, Auricchio A, Ronchi A, Del Sorbo G, Panarese I, Ferraraccio F, De Vita F, Galizia G, Cardella F. Presence of tumor deposits is a strong indicator of poor outcome in patients with stage III colorectal cancers undergoing radical surgery. J Gastrointest Surg. 2024 Jan;28(1):47-56. doi: 10.1016/j.gassur.2023.11.003.
PubMed 38353074
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presence of Tumor Deposits is a Strong Indicator of Poor Outcome in Stage III Colorectal Cancers Undergoing Radical Surgery: Need for an Urgent Revision of the Staging System
- ClinicalTrials.gov ID
- NCT05923450
- Acronym / sponsor ID
- TD / Vanvitelli Naples
- Conditions
- Extranodal Extension
- Keywords
- tumor deposits, colorectal cancers, TNM staging system, ROC Curve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 28 Jun 2023 (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.
Tumor deposits (TDs) are emerging as an adverse prognostic factor in colorectal cancers (CRCs), but they are quite ignored in the current staging system. Previous proposals to incorporate TDs in node stage or consider them distant metastases raised some doubt. The Authors propose a new staging system to optimize treatments.
Detailed description
Tumor deposits (TDs) are emerging as an adverse prognostic factor in colorectal cancers (CRCs).In the current staging system TDs are somewhat neglected.
It has been proposed to add TD count to the number of metastatic lymph nodes or to consider TDs as distant metastases, but the scientific basis of these proposals seems dubious and not supported by robust statistical analyses.
The investigators supposed that splitting the three sub-stages of the stage III CRC according to absence or presence of TDs could be an easy and useful method to avoid the loss of crucial information. The proposed study will include 243 stage III CRC patients undergoing radical surgery and adjuvant chemotherapy. Each new substage, according to absence or presence of tumor deposits, will be analyzed with sophisticated statistical analysis (particularly the area-under-curve (AUC), calculated by the time-dependent receiver-operating-characteristic (ROC) curve for censored survival data) to individuate if this new staging does better the current one.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor Deposits | – | Procedure: Colorectal ResectionColorectal cancers with and without tumor deposits, undergoing curative surgery and adjuvant chemotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- colorectal cancer patients with metastatic nodes undergoing radical surgery and adjuvant chemotherapy
Key inclusion criteria (1 listed)
- colorectal cancers in stage III TNM undergoing radical surgery and adjuvant chemotherapy
Key exclusion criteria (5 listed)
- Lynch syndrome
- Rectal Cancer undergoing neoadjuvant (radio)chemotherapy
- colorectal cancers without metastatic nodes
- metastatic colorectal cancers
- eligible patients refusing adjuvant chemotherapy
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 |
|---|---|---|
| Colorectal ResectionRadical resection of colorectal cancer | Procedure or surgery | Tumor Deposits |
Primary outcome
Overall Survival
Time frame: 5 years
1 to 5 years overall survival
Disease-free Survival
Time frame: 5 years
1 to 5 years disease-free survival
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 29 Jun 2023.
- Background: PubMed 29112563Galizia G, Lieto E, Auricchio A, Cardella F, Mabilia A, Podzemny V, Castellano P, Orditura M, Napolitano V. Naples Prognostic Score, Based on Nutritional and Inflammatory Status, is an Independent Predictor of Long-term Outcome in Patients Undergoing Surgery for Colorectal Cancer. Dis Colon Rectum. 2017 Dec;60(12):1273-1284. doi: 10.1097/DCR.0000000000000961.
- Results publication: PubMed 36307056Cervantes A, Adam R, Rosello S, Arnold D, Normanno N, Taieb J, Seligmann J, De Baere T, Osterlund P, Yoshino T, Martinelli E; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Metastatic colorectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Jan;34(1):10-32. doi: 10.1016/j.annonc.2022.10.003. Epub 2022 Oct 25. No abstract available.
- Results publication: PubMed 34954753Pyo DH, Kim SH, Ha SY, Yun SH, Cho YB, Huh JW, Park YA, Shin JK, Lee WY, Kim HC. Revised Nodal Staging Integrating Tumor Deposit Counts With Positive Lymph Nodes in Patients With Stage III Colon Cancer. Ann Surg. 2023 Apr 1;277(4):e825-e831. doi: 10.1097/SLA.0000000000005355. Epub 2021 Dec 23.
- Results publication: PubMed 36790093Khan H, Radomski SN, Siddiqi A, Zhou N, Paneitz DC, Johnston FM, Greer JB. Tumor deposits are associated with a higher risk of peritoneal disease in non-metastatic colorectal cancer patients. J Surg Oncol. 2023 May;127(6):975-982. doi: 10.1002/jso.27207. Epub 2023 Feb 15.
- Derived from this study: PubMed 38353074Lieto E, Auricchio A, Ronchi A, Del Sorbo G, Panarese I, Ferraraccio F, De Vita F, Galizia G, Cardella F. Presence of tumor deposits is a strong indicator of poor outcome in patients with stage III colorectal cancers undergoing radical surgery. J Gastrointest Surg. 2024 Jan;28(1):47-56. doi: 10.1016/j.gassur.2023.11.003.
- Individual participant dataSharing planned: Yes. all data will be shared after publication
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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.
Gennaro Galizia, MD principal investigator
University of Campania 'Luigi Vanvitelli'
Questions about this trial
What is this clinical trial studying?
An observational study of Extranodal Extension, run by University of Campania Luigi Vanvitelli.
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 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: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Overall Survival (time frame: 5 years). 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?
On the ClinicalTrials.gov record for NCT05923450, which also lists 5 linked publications.
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 29 Jun 2023.