Head and Neck CancerNCT03534778
Prognostic Significance of Lymph Node Yield and Lymph Node Ratio Prospective Observational Study
An observational study of Head and Neck Cancer, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
It is still unclear if Lymph Node Yield (LNY) and Lymph Node Ratio (LNR) may have a prognostic role in patients affected by carcinoma of the oral cavity and the oropharynx. Only retrospective studies are available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Lymph Node Yield (LNY) and Lymph Node Ratio (LNR)
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 1 Jan 2024
- 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 affected by oral or oropharyngeal squamous cell carcinoma who undergo upfront surgery and neck dissection
Who may be able to join
- patients affected by oral cavity, oropharynx, larynx squamous cell carcinoma
Who cannot join
- patients affected by other cancers
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Oreste Iocca
Milan, MI, 20138
oreste iocca, 3398540121, oreste.iocca86@gmail.com
About this study
Official title: Prognostic Significance of Lymph Node Yield and Lymph Node Ratio in Patients Affected by Squamous Cell Carcinoma of the Oral Cavity, Hypopharynx and Larynx: a Prospective, Multicenter Observational Study
It is still unclear if Lymph Node Yield (LNY) and Lymph Node Ratio (LNR) may have a prognostic role in patients affected by carcinoma of the oral cavity and the oropharynx. Only retrospective studies are available. For this reason, this prospective, multi center, observational study should provide indications in this regard. Proper stratification by patients characteristics will allow to understand if LNY and LNR may enter in the future TNM staging system
Read the detailed description
Lymph node involvement is a fundamental prognostic factor in head and neck squamous cell carcinoma (SCC). Lymph node yield (LNY), which is the number of lymph nodes retrieved after neck dissection, and lymph node ratio (LNR), which is the ratio of positive lymph nodes out of the total removed, are measurable indicators that may have the potential to be used as prognostic factors. The present study is designed to define the exact role of LNY and LNR regarding the overall and specific survival of patients affected by oral cavity and oropharyngeal SCC.
This is a multicenter study involving tertiary care referral centers in Europe and North America. Patients affected by oral cavity, HPV+ and HPV- oropharyngeal SCC undergoing neck dissection will be consecutively enrolled and followed-up for up to 5 years. Patients and disease characteristic will be properly recorded and centrally analyzed. The primary end-point is to define reliable cut off- values for LNY and LNR which may serve as prognosticators of survival. This will be achieved through the use of ROC curves. Secondary outcomes will be the Overall survival (OS), Disease Specific Survival (DSS), and Progression Free Survival Hazard Ratios (HR) at 2-, 3- and 5 years, which will be evaluated through the Kaplan-Meier method and the difference in survival attested by the log-rank test. Univariate and multivariate analysis will be performed to understand the association of various outcomes with LNY and LNR.
- Conditions
- Head and Neck Cancer
- Being tested
- Lymph Node Yield (LNY) and Lymph Node Ratio (LNR)
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymph Node Yield (LNY) and Lymph Node Ratio (LNR)Diagnostic test
LNY and LNR will be examined after neck dissection
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing neck dissection | all patients undergoing neck dissection Receives: Diagnostic Test: Lymph Node Yield (LNY) and Lymph Node Ratio (LNR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal cut-off value for 5 year Overall 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 posted23 May 2018
- Study start1 Jan 2019
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oreste Iocca, M.D., D.D.S., Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534778
- Sponsor's protocol ID
- LNYLNR
- Status last verified
- Apr 2019
- First submitted
- 11 May 2018
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Iocca O, Farcomeni A, De Virgilio A, Di Maio P, Golusinski P, Malvezzi L, Pellini R, Golusinski W, Rassekh CH, Spriano G. Prognostic significance of lymph node yield and lymph node ratio in patients affected by squamous cell carcinoma of the oral cavity and oropharynx: Study protocol for a prospective, multicenter, observational study. Contemp Clin Trials Commun. 2019 Jan 14;14:100324. doi: 10.1016/j.conctc.2019.100324. eCollection 2019 Jun.
PubMed 30723839
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Significance of Lymph Node Yield and Lymph Node Ratio in Patients Affected by Squamous Cell Carcinoma of the Oral Cavity, Hypopharynx and Larynx: a Prospective, Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT03534778
- Acronym / sponsor ID
- LNYLNR
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 23 May 2018 (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.
It is still unclear if Lymph Node Yield (LNY) and Lymph Node Ratio (LNR) may have a prognostic role in patients affected by carcinoma of the oral cavity and the oropharynx. Only retrospective studies are available. For this reason, this prospective, multi center, observational study should provide indications in this regard. Proper stratification by patients characteristics will allow to understand if LNY and LNR may enter in the future TNM staging system
Detailed description
Lymph node involvement is a fundamental prognostic factor in head and neck squamous cell carcinoma (SCC). Lymph node yield (LNY), which is the number of lymph nodes retrieved after neck dissection, and lymph node ratio (LNR), which is the ratio of positive lymph nodes out of the total removed, are measurable indicators that may have the potential to be used as prognostic factors. The present study is designed to define the exact role of LNY and LNR regarding the overall and specific survival of patients affected by oral cavity and oropharyngeal SCC.
This is a multicenter study involving tertiary care referral centers in Europe and North America. Patients affected by oral cavity, HPV+ and HPV- oropharyngeal SCC undergoing neck dissection will be consecutively enrolled and followed-up for up to 5 years. Patients and disease characteristic will be properly recorded and centrally analyzed. The primary end-point is to define reliable cut off- values for LNY and LNR which may serve as prognosticators of survival. This will be achieved through the use of ROC curves. Secondary outcomes will be the Overall survival (OS), Disease Specific Survival (DSS), and Progression Free Survival Hazard Ratios (HR) at 2-, 3- and 5 years, which will be evaluated through the Kaplan-Meier method and the difference in survival attested by the log-rank test. Univariate and multivariate analysis will be performed to understand the association of various outcomes with LNY and LNR.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing neck dissection | – | Diagnostic Test: Lymph Node Yield (LNY) and Lymph Node Ratio (LNR)all patients undergoing neck dissection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by oral or oropharyngeal squamous cell carcinoma who undergo upfront surgery and neck dissection
Key inclusion criteria (1 listed)
- patients affected by oral cavity, oropharynx, larynx squamous cell carcinoma
Key exclusion criteria (1 listed)
- patients affected by other cancers
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 Yield (LNY) and Lymph Node Ratio (LNR)LNY and LNR will be examined after neck dissection | Diagnostic test | patients undergoing neck dissection |
Primary outcome
Optimal cut-off value for 5 year Overall Survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Derived from this study: PubMed 30723839Iocca O, Farcomeni A, De Virgilio A, Di Maio P, Golusinski P, Malvezzi L, Pellini R, Golusinski W, Rassekh CH, Spriano G. Prognostic significance of lymph node yield and lymph node ratio in patients affected by squamous cell carcinoma of the oral cavity and oropharynx: Study protocol for a prospective, multicenter, observational study. Contemp Clin Trials Commun. 2019 Jan 14;14:100324. doi: 10.1016/j.conctc.2019.100324. eCollection 2019 Jun.
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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.
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 Head and Neck Cancer, run by University of Roma La Sapienza at 1 site in Italy.
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: status not confirmed, as of the sponsor's last update on 19 Apr 2019. 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal cut-off value for 5 year Overall Survival (time frame: 5 years). 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 NCT03534778, which also lists 1 linked publication.
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 19 Apr 2019.