Towards A Better Paradigm for Head and Neck Cancer Treatment Applying Artificial Intelligence. HNC-TACTIC. (HNC-TACTIC)

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Other: No intervention - Just description and predictive models

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 Type: Observational
• Enrollment (Actual): 10000

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain, 28013
      • Savan Research S.L

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• Patients ≥18 years old.
• Patients diagnosed with HNSCC
• For selected exploratory analyses, patients diagnosed with nasopharynx, paranasal sinus, and salivary gland tumors.

Exclusion Criteria:

• Patients with follow-up of less than 6 months, except if deceased (any cause) in the 6 months after HNSCC diagnosis

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: No intervention - Just description and predictive models; All the groups will be descriptive, there is not intervention, as it is an Observational study applying artificial Intelligence (RWE).
Patients with early and locally advanced stages; To describe clinical characteristics and treatments and to compare OS in locally advanced HNSCC patients	Other: No intervention - Just description and predictive models; All the groups will be descriptive, there is not intervention, as it is an Observational study applying artificial Intelligence (RWE).
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	Other: No intervention - Just description and predictive models; All the groups will be descriptive, there is not intervention, as it is an Observational study applying artificial Intelligence (RWE).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	From 1st Jan 2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	From 1st Jan 2021

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory objective	To describe the demographics, clinical characteristics, and treatment of patients with nasopharynx, paranasal sinus, and salivary gland tumors.	From 1st Jan 2021

Collaborators and Investigators

• Sponsor: Savana Research
• Collaborators: Head and Neck Cancer International Group (HNCIG)
• Investigators: Study Chair: John Almeida, University Health Network and Mount Sinai Hospital; Study Chair: Sujith Baliaga, Ohio State University; Study Chair: David Casadevall, Medsavana S.L; Study Chair: Melvin Chua, National Cancer Centre, Singapore; Study Chair: Andreas Dietz, University Hospital of Leipzig; Study Chair: Robert Ferris, UPMC Hillman Cancer Center; Study Chair: Raul Giglio, Hopital Ángel H. Roffo de Buenos Aires; Study Chair: Chris Holsinger, Stanford University; Study Chair: Kate Hutcheson, M.D. Anderson Cancer Center; Study Chair: Husham Menhanna, Institute of Head and Neck Studies and Education (InHANSE); Study Chair: Pablo Parente, Hospital HM Rosaleda; Study Chair: Sandro Porceddu, Queensland Institute of Medical Research (QIMR); Principal Investigator: Miren Taberna, Medsavana S.L; Study Chair: Christian Simon, CHUV Lausanne

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2021
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: November 2, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Immunotherapy; HNSCC; Artificial intelligence; Predictive factors; Overall survival; Natural language processing; Electronic health records
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms
• Other Study ID Numbers: HNC-TACTIC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No