NCT05117775|Completed
Towards A Better Paradigm for Head and Neck Cancer Treatment Applying Artificial Intelligence. HNC-TACTIC.
HNC-TACTIC
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HNC-TACTIC
Sponsor study identifier
observational
10,000
1 country
1
Study Start
December 6, 2021
Actual (reported)Primary Completion
February 28, 2024
Actual (reported)Study Completion
December 31, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 8, 2021
Actual (reported)November 11, 2021
Actual (reported)December 6, 2021
Actual (reported)February 28, 2024
Actual (reported)December 31, 2024
Actual (reported)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
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
Exploratory objective
From 1st Jan 2021
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 clinical characteristics and treatments and to compare OS in locally advanced HNSCC patients
To describe the epidemiologic and clinical characteristics, and treatment and the impact of introducing immunotherapy in recurrent or metastatic HNSCC
All the groups will be descriptive, there is not intervention, as it is an Observational study applying artificial Intelligence (RWE).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Savan Research S.L
Madrid, Madrid, 28013, Spain
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.
John Almeida
University Health Network and Mount Sinai Hospital
Sujith Baliaga
Ohio State University
David Casadevall
Medsavana S.L
Melvin Chua
National Cancer Centre, Singapore
10,000 participants (actual enrollment reported by the registry).
First Submitted
October 8, 2021
First Posted
November 11, 2021
Study Start
December 6, 2021
Actual (reported)A Comprehensive Approach to Head and Neck Cancer Prehabilitation
Contact the study team to confirm eligibility.
Andreas Dietz
University Hospital of Leipzig
Robert Ferris
UPMC Hillman Cancer Center
Raul Giglio
Hopital Ángel H. Roffo de Buenos Aires
Chris Holsinger
Stanford University
Kate Hutcheson
M.D. Anderson Cancer Center
Husham Menhanna
Institute of Head and Neck Studies and Education (InHANSE)
Pablo Parente
Hospital HM Rosaleda
Sandro Porceddu
Queensland Institute of Medical Research (QIMR)
Miren Taberna
Medsavana S.L
Christian Simon
CHUV Lausanne
Primary Completion
February 28, 2024
Actual (reported)Study Completion
December 31, 2024
Actual (reported)Last Updated
May 1, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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