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

Sponsor

Savana Research (Other)

Overall Status

Recruiting

CT.gov ID

NCT05117775

Collaborator

Head and Neck Cancer International Group (HNCIG) (Other)

10,000

Enrollment

Location

24.8

Anticipated Duration (Months)

403.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	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 Design

Study Type:

Observational

Anticipated Enrollment :

10000 participants

Observational Model:

Other

Time Perspective:

Retrospective

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.

Actual Study Start Date :

Dec 6, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	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).

Arm

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).

Outcome Measures

Primary Outcome Measures

Predictive model based on dynamic risk stratification (DRS) for the risk of recurrence or disease progression [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 [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

Secondary Outcome Measures

In all patients with all stages of HNSCC (full analysis set, FAS): [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.
In patients with early and locally advanced stages of the disease (including all patients treated with curative intent): [From 1st Jan 2021]
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
In patients with recurrent or metastatic disease: [From 1st Jan 2021]
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.

Other Outcome Measures

Exploratory objective [From 1st Jan 2021]
To describe the demographics, clinical characteristics, and treatment of patients with nasopharynx, paranasal sinus, and salivary gland tumors.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Savan Research S.L	Madrid		Spain	28013

Sponsors and Collaborators

Savana Research
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