Head and Neck CancerHNC-TACTICNCT05117775
Towards A Better Paradigm for Head and Neck Cancer Treatment Applying Artificial Intelligence. HNC-TACTIC.
An observational study of Head and Neck Cancer, run by Savana Research at 1 site in Spain.
Trial summary
This will be an international, multicenter, retrospective, observational, and data-driven study using secondary data captured in EHRs. The extraction of the data captured in the EHRs will be performed with SAVANA's EHRead®, an innovative data-driven system based on Natural Language Processing (NLP) and machine… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- Type of treatment
- Pill or oral medicine
- How many people
- 10,000 participants
- Where
- 1 siteSpain
- Study dates
- 6 Dec 2021to 31 Dec 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: The Full Analysis Set (FAS) will comprise all adult patients with all stages of HNSCC. For completion of secondary objectives, two different subgroups based on stage of the disease will be considered. Treatment approaches will be analyzed in different cohorts of patients within each subgroup. * Partial Analysis Set (PAS) 1: Patients with early stages of the disease * PAS 2.1: Patients with locally advanced stages of the disease diagnosed with HPV-negative HNSC. * PAS 2.2: Patients with locally advanced stages of the disease diagnosed with HPV-positive oropharyngeal squamous cell carcinoma. * PAS 3: Patients with recurrent/metastatic disease. * PAS 4 (for exploratory analysis): Patients diagnosed with nasopharynx, paranasal sinus, and salivary gland tumors.
Who may be able to join
- Patients ≥18 years old.
- Patients diagnosed with HNSCC
- For selected exploratory analyses, patients diagnosed with nasopharynx, paranasal sinus, and salivary gland tumors.
Who cannot join
- Patients with follow-up of less than 6 months, except if deceased (any cause) in the 6 months after HNSCC diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Towards A Better Paradigm for Head and Neck Cancer Treatment Applying Artificial Intelligence: an International Cohort Study of Electronic Health Records. HNC-TACTIC.
This will be an international, multicenter, retrospective, observational, and data-driven study using secondary data captured in EHRs. The extraction of the data captured in the EHRs will be performed with SAVANA's EHRead®, an innovative data-driven system based on Natural Language Processing (NLP) and machine learning. For all patients, the Index Date is defined as the timepoint within the study period when they fulfill ALL inclusion criteria and no exclusion criteria. Follow-up comprises the period between Index Date and the last EHR available within the study period. Additional variable-specific time windows may be considered to optimize data collection.
Read the detailed description
The present study aims to describe the clinical characteristics of patients with HNSCC in a real-world setting by analyzing readily available information in the Electronic Health Records (EHRs). This study will gain a deep insight of the clinical characteristics and real-world outcomes of patients with all stages (early, locally advanced, and metastatic) of HNSCC. It will focus on developing two predictive models to apply in the clinical setting, one for electing patients with high-risk of recurrence after radical treatment, and the second one for selecting recurrent or metastatic patients who could benefit from immunotherapy.
To achieve the proposed study objectives we will use SAVANA´s EHRead® (11-15), a technology that applies Natural Language Processing (NLP) (16) and machine learning to extract, organize, and analyze the unstructured clinical information jotted down by health professionals in patients' EHRs.
Primary objectives
- To develop a predictive model based on dynamic risk stratification (DRS) for the risk of recurrence or disease progression following a primary curative treatment in HNSCC patients with early and locally advanced disease.
- To develop a predictive model based on dynamic risk stratification (DRS) aimed at identifying patients' features that predict long-term survival after immunotherapy in recurrent and metastatic HNSCC patients. Secondary objectives
- To describe median OS by primary tumor location (oral cavity, oropharynx, larynx, and hypopharynx) in HNSCC patients after stratification for prognostic factors, including tumor stage and treatment.
- To describe the demographics, clinical characteristics, and treatment of patients with HNSCC in early and locally advanced stages of the disease.
- To describe the patterns of follow-up in patients with HNSCC in early and locally advanced stages of the disease.
- Departments in charge
- Number of visits
- Imaging and anatomopathological tests
- Recurrence detected by physical examination.
- To evaluate the impact of treatments on patients with locally advanced stages of the disease.
- Patients' early and late toxicity to the treatment, comparing between radiotherapy (+/-cisplatin or cetuximab) vs surgery and post-operative r< radiotherapy (+/- cisplatin).
- Healthcare resource utilization (HCRU), including medical visits, diagnostics, and hospitalizations.
- To compare OS in locally advanced HNSCC patients (including both HPV+ and HPV- oropharyngeal patients) treated with cisplatin-radiotherapy vs cetuximab-radiotherapy and treated with surgery vs. conservative treatment.
- To compare the demographic and clinical characteristics of exceptional responders and poor responders (based on recurrence and long-term survival). This analysis will be performed independently for HPV+ and HPV- oropharyngeal patients.
- Conditions
- Head and Neck Cancer
- Being tested
- No intervention - Just description and predictive models
- Keywords
- HNSCC, Predictive factors, Overall survival, Immunotherapy, Electronic health records, Natural language processing, Artificial intelligence
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - Just description and predictive modelsOther
All the groups will be descriptive, there is not intervention, as it is an Observational study applying artificial Intelligence (RWE).
| Study group | Role | What they receive |
|---|---|---|
| Patients with all stages of HNSCC (Full analysis set) | To describe median OS by primary tumor location (oral cavity, oropharynx, larynx, and hypopharynx) in HNSCC patients after stratification for prognostic factors, including tumor stage and treatment. Receives: Other: No intervention - Just description and predictive models | |
| Patients with early and locally advanced stages | To describe clinical characteristics and treatments and to compare OS in locally advanced HNSCC patients Receives: Other: No intervention - Just description and predictive models | |
| Patients with recurrent or metastatic disease | To describe the epidemiologic and clinical characteristics, and treatment and the impact of introducing immunotherapy in recurrent or metastatic HNSCC Receives: Other: No intervention - Just description and predictive models |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive model based on dynamic risk stratification (DRS) for the risk of recurrence or disease progression
To develop a predictive model based on dynamic risk stratification (DRS) for the risk of recurrence or disease progression following a primary curative treatment in HNSCC patients with early and locally advanced disease.
Measured: From 1st Jan 2021
Predictive model based on dynamic risk stratification (DRS) aimed at identifying patients' features
To develop a predictive model based on dynamic risk stratification (DRS) aimed at identifying patients' features that predict long-term survival after immunotherapy in recurrent and metastatic HNSCC patients
Measured: From 1st Jan 2021
Secondary outcomes (3)
In all patients with all stages of HNSCC (full analysis set, FAS):
To describe median OS by primary tumor location (oral cavity, oropharynx, larynx, and hypopharynx) in HNSCC patients after stratification for prognostic factors, including tumor stage and treatment.
Measured: From 1st Jan 2021
In patients with early and locally advanced stages of the disease (including all patients treated with curative intent):
- To describe the demographics, clinical characteristics, and treatments
- To describe the patterns of follow-up
- Departments in charge
- Number of visits
- Imaging and anatomopathological tests
- Recurrence detected by physical examination
- To evaluate the impact of treatments on patients with locally advanced stages of the disease.
- Patients' early and late toxicity to the treatment, comparing between radiotherapy (cisplatin or cetuximab) vs surgery and post-operative radiotherapy (cisplatin)
- Healthcare resource utilization (HCRU), including medical visits, diagnostics, and hospitalizations.
- To compare OS in locally advanced HNSCC patients (including both HPV+ and HPV- oropharyngeal patients) treated with cisplati
Measured: From 1st Jan 2021
In patients with recurrent or metastatic disease:
- To describe the epidemiologic and clinical characteristics, and treatments
- To describe epidemiologic, clinical, and tumor characteristics of long-term survivors treated with immunotherapy and non-immunotherapy approaches.
- To describe the impact of introducing immunotherapy in recurrent or metastatic
HNSCC:
- Treatment outcome: OS
- HCRU, including medical visits, diagnostics, and hospitalizations.
Measured: From 1st Jan 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start6 Dec 2021
- Primary completion28 Feb 2024
- Study completion31 Dec 2024
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.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Savana Research
- Sponsor type
- Research network
- Collaborators
- Head and Neck Cancer International Group (HNCIG)
- Responsible party
- Sponsor
- Investigators
- John Almeida, Study chair, University Health Network and Mount Sinai HospitalSujith Baliaga, Study chair, Ohio State UniversityDavid Casadevall, Study chair, Medsavana S.LMelvin Chua, Study chair, National Cancer Centre, SingaporeAndreas Dietz, Study chair, University Hospital of LeipzigRobert Ferris, Study chair, UPMC Hillman Cancer CenterRaul Giglio, Study chair, Hopital Ángel H. Roffo de Buenos AiresChris Holsinger, Study chair, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117775
- Sponsor's protocol ID
- HNC-TACTIC
- Acronym
- HNC-TACTIC
- Status last verified
- Apr 2026
- First submitted
- 8 Oct 2021
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mehanna H, Rogado J, Castro Calvo A, Gonzalez V, Aguilar F, Culie D, Sanabria A, Zuniga Pavia SF, Guix M, Baliga S, Giger R, Hool SL, Elicin O, Stoehr M, Abou-Foul AK, Chua MLK, Parente P, Dietz A, de Almeida JR, Simon C, Holsinger FC, Ferris R, Giglio R, Hutcheson K, Casadevall D, Taberna M. Toward a Better Paradigm for Head and Neck Cancer Treatment Applying AI (HNC-TACTIC): Protocol for an International Cohort Study of Electronic Health Records. JMIR Res Protoc. 2026 Jul 13;15:e83598. doi: 10.2196/83598.
PubMed 42441711
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards A Better Paradigm for Head and Neck Cancer Treatment Applying Artificial Intelligence: an International Cohort Study of Electronic Health Records. HNC-TACTIC.
- ClinicalTrials.gov ID
- NCT05117775
- Acronym / sponsor ID
- HNC-TACTIC / HNC-TACTIC
- Conditions
- Head and Neck Cancer
- Keywords
- HNSCC, Predictive factors, Overall survival, Immunotherapy, Electronic health records, Natural language processing, Artificial intelligence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Savana ResearchResearch network
- Collaborators
- Head and Neck Cancer International Group (HNCIG)
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 11 Nov 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.
This will be an international, multicenter, retrospective, observational, and data-driven study using secondary data captured in EHRs. The extraction of the data captured in the EHRs will be performed with SAVANA's EHRead®, an innovative data-driven system based on Natural Language Processing (NLP) and machine learning. For all patients, the Index Date is defined as the timepoint within the study period when they fulfill ALL inclusion criteria and no exclusion criteria. Follow-up comprises the period between Index Date and the last EHR available within the study period. Additional variable-specific time windows may be considered to optimize data collection.
Detailed description
The present study aims to describe the clinical characteristics of patients with HNSCC in a real-world setting by analyzing readily available information in the Electronic Health Records (EHRs). This study will gain a deep insight of the clinical characteristics and real-world outcomes of patients with all stages (early, locally advanced, and metastatic) of HNSCC. It will focus on developing two predictive models to apply in the clinical setting, one for electing patients with high-risk of recurrence after radical treatment, and the second one for selecting recurrent or metastatic patients who could benefit from immunotherapy.
To achieve the proposed study objectives we will use SAVANA´s EHRead® (11-15), a technology that applies Natural Language Processing (NLP) (16) and machine learning to extract, organize, and analyze the unstructured clinical information jotted down by health professionals in patients' EHRs.
Primary objectives
- To develop a predictive model based on dynamic risk stratification (DRS) for the risk of recurrence or disease progression following a primary curative treatment in HNSCC patients with early and locally advanced disease.
- To develop a predictive model based on dynamic risk stratification (DRS) aimed at identifying patients' features that predict long-term survival after immunotherapy in recurrent and metastatic HNSCC patients. Secondary objectives
- To describe median OS by primary tumor location (oral cavity, oropharynx, larynx, and hypopharynx) in HNSCC patients after stratification for prognostic factors, including tumor stage and treatment.
- To describe the demographics, clinical characteristics, and treatment of patients with HNSCC in early and locally advanced stages of the disease.
- To describe the patterns of follow-up in patients with HNSCC in early and locally advanced stages of the disease.
- Departments in charge
- Number of visits
- Imaging and anatomopathological tests
- Recurrence detected by physical examination.
- To evaluate the impact of treatments on patients with locally advanced stages of the disease.
- Patients' early and late toxicity to the treatment, comparing between radiotherapy (+/-cisplatin or cetuximab) vs surgery and post-operative r< radiotherapy (+/- cisplatin).
- Healthcare resource utilization (HCRU), including medical visits, diagnostics, and hospitalizations.
- To compare OS in locally advanced HNSCC patients (including both HPV+ and HPV- oropharyngeal patients) treated with cisplatin-radiotherapy vs cetuximab-radiotherapy and treated with surgery vs. conservative treatment.
- To compare the demographic and clinical characteristics of exceptional responders and poor responders (based on recurrence and long-term survival). This analysis will be performed independently for HPV+ and HPV- oropharyngeal patients.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with all stages of HNSCC (Full analysis set) | – | Other: No intervention - Just description and predictive modelsTo describe median OS by primary tumor location (oral cavity, oropharynx, larynx, and hypopharynx) in HNSCC patients after stratification for prognostic factors, including tumor stage and treatment. |
| Patients with early and locally advanced stages | – | Other: No intervention - Just description and predictive modelsTo describe clinical characteristics and treatments and to compare OS in locally advanced HNSCC patients |
| Patients with recurrent or metastatic disease | – | Other: No intervention - Just description and predictive modelsTo describe the epidemiologic and clinical characteristics, and treatment and the impact of introducing immunotherapy in recurrent or metastatic HNSCC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Full Analysis Set (FAS) will comprise all adult patients with all stages of HNSCC. For completion of secondary objectives, two different subgroups based on stage of the disease will be considered. Treatment approaches will be analyzed in different cohorts of patients within each subgroup. * Partial Analysis Set (PAS) 1: Patients with early stages of the disease * PAS 2.1: Patients with locally advanced stages of the disease diagnosed with HPV-negative HNSC. * PAS 2.2: Patients with locally advanced stages of the disease diagnosed with HPV-positive oropharyngeal squamous cell carcinoma. * PAS 3: Patients with recurrent/metastatic disease. * PAS 4 (for exploratory analysis): Patients diagnosed with nasopharynx, paranasal sinus, and salivary gland tumors.
Key inclusion criteria (3 listed)
- Patients ≥18 years old.
- Patients diagnosed with HNSCC
- For selected exploratory analyses, patients diagnosed with nasopharynx, paranasal sinus, and salivary gland tumors.
Key exclusion criteria (1 listed)
- Patients with follow-up of less than 6 months, except if deceased (any cause) in the 6 months after HNSCC diagnosis
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 |
|---|---|---|
| No intervention - Just description and predictive modelsAll the groups will be descriptive, there is not intervention, as it is an Observational study applying artificial Intelligence (RWE). | Other | Patients with all stages of HNSCC (Full analysis set), Patients with early and locally advanced stages, Patients with recurrent or metastatic disease |
Primary outcome
Predictive model based on dynamic risk stratification (DRS) for the risk of recurrence or disease progression
Time frame: From 1st Jan 2021
To develop a predictive model based on dynamic risk stratification (DRS) for the risk of recurrence or disease progression following a primary curative treatment in HNSCC patients with early and locally advanced disease.
Predictive model based on dynamic risk stratification (DRS) aimed at identifying patients' features
Time frame: From 1st Jan 2021
To develop a predictive model based on dynamic risk stratification (DRS) aimed at identifying patients' features that predict long-term survival after immunotherapy in recurrent and metastatic HNSCC patients
3 secondary outcomes
In all patients with all stages of HNSCC (full analysis set, FAS):
Time frame: From 1st Jan 2021
In patients with early and locally advanced stages of the disease (including all patients treated with curative intent):
Time frame: From 1st Jan 2021
In patients with recurrent or metastatic disease:
Time frame: From 1st Jan 2021
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 1 May 2026.
- Derived from this study: PubMed 42441711Mehanna H, Rogado J, Castro Calvo A, Gonzalez V, Aguilar F, Culie D, Sanabria A, Zuniga Pavia SF, Guix M, Baliga S, Giger R, Hool SL, Elicin O, Stoehr M, Abou-Foul AK, Chua MLK, Parente P, Dietz A, de Almeida JR, Simon C, Holsinger FC, Ferris R, Giglio R, Hutcheson K, Casadevall D, Taberna M. Toward a Better Paradigm for Head and Neck Cancer Treatment Applying AI (HNC-TACTIC): Protocol for an International Cohort Study of Electronic Health Records. JMIR Res Protoc. 2026 Jul 13;15:e83598. doi: 10.2196/83598.
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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.
John Almeida study chair
University Health Network and Mount Sinai Hospital
Sujith Baliaga study chair
Ohio State University
David Casadevall study chair
Medsavana S.L
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 Savana Research at 1 site in Spain.
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 3 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 1 May 2026. 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 Spain. 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?
Predictive model based on dynamic risk stratification (DRS) for the risk of recurrence or disease progression (time frame: From 1st Jan 2021). 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 NCT05117775, 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 1 May 2026.