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

NCT ID: NCT05117775

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-06

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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Head and Neck Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No intervention - Just description and predictive models

Intervention Type OTHER

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

No intervention - Just description and predictive models

Intervention Type OTHER

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

No intervention - Just description and predictive models

Intervention Type OTHER

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

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Head and Neck Cancer International Group (HNCIG)

UNKNOWN

Sponsor Role collaborator

Savana Research

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Almeida

Role: STUDY_CHAIR

University Health Network and Mount Sinai Hospital

Sujith Baliaga

Role: STUDY_CHAIR

Ohio State University

David Casadevall

Role: STUDY_CHAIR

Medsavana S.L

Melvin Chua

Role: STUDY_CHAIR

National Cancer Centre, Singapore

Andreas Dietz

Role: STUDY_CHAIR

University Hospital of Leipzig

Robert Ferris

Role: STUDY_CHAIR

UPMC Hillman Cancer Center

Raul Giglio

Role: STUDY_CHAIR

Hopital Ángel H. Roffo de Buenos Aires

Chris Holsinger

Role: STUDY_CHAIR

Stanford University

Kate Hutcheson

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Husham Menhanna

Role: STUDY_CHAIR

Institute of Head and Neck Studies and Education (InHANSE)

Pablo Parente

Role: STUDY_CHAIR

Hospital HM Rosaleda

Sandro Porceddu

Role: STUDY_CHAIR

Queensland Institute of Medical Research (QIMR)

Miren Taberna

Role: PRINCIPAL_INVESTIGATOR

Medsavana S.L

Christian Simon

Role: STUDY_CHAIR

CHUV Lausanne

Locations

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Savan Research S.L

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Miren Taberna, MD,PhD

Role: CONTACT

[email protected]
[+34] 910 69 69 02

Facility Contacts

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Miren Taberna

Role: primary

Other Identifiers

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HNC-TACTIC

Identifier Type: -

Identifier Source: org_study_id