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

NCT05117775 | Completed

• 1 other identifier: HNC-TACTIC
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Head and Neck Cancer

Keywords

HNSCC; Predictive factors; Overall survival; Immunotherapy; Electronic health records; Natural language processing; Artificial intelligence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• In all patients with all stages of HNSCC (full analysis set, FAS):

  From 1st Jan 2021

• In patients with early and locally advanced stages of the disease (including all patients treated with curative intent):

  From 1st Jan 2021

• In patients with recurrent or metastatic disease:

  From 1st Jan 2021

Other Outcomes (1)

• Exploratory objective

  From 1st Jan 2021

Study Arms (3)

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

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

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

Interventions

No intervention - Just description and predictive models OTHER

All the groups will be descriptive, there is not intervention, as it is an Observational study applying artificial Intelligence (RWE).

Patients with all stages of HNSCC (Full analysis set); Patients with early and locally advanced stages; Patients with recurrent or metastatic disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Savana Research: lead
• Head and Neck Cancer International Group (HNCIG): collaborator

Study Sites (1)

Savan Research S.L

Madrid, Madrid, 28013, Spain

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• 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)

  STUDY CHAIR

• Miren Taberna

  Medsavana S.L

  PRINCIPAL INVESTIGATOR

• Christian Simon

  CHUV Lausanne

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: November 11, 2021
• Study Start: December 6, 2021
• Primary Completion: February 28, 2024
• Study Completion: December 31, 2024
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

ES (1)