Clinical trial NCT05117775: Towards A Better Paradigm for Head and Neck Cancer Treatment Applying Artificial Intelligence. HNC-TACTIC.
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Keywords: HNSCC
Predictive factors
Overall survival
Immunotherapy
Electronic health records
Natural language processing
Artificial intelligence
Lead sponsor: Savana Research
Sponsor class: NETWORK
Collaborators: name: Head and Neck Cancer International Group (HNCIG)
First posted: 2021-11-11
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Predictive model based on dynamic risk stratification (DRS) for the risk of recurrence or disease progression
timeFrame: From 1st Jan 2021
measure: Predictive model based on dynamic risk stratification (DRS) aimed at identifying patients' features
timeFrame: From 1st Jan 2021
Secondary outcomes:
measure: In all patients with all stages of HNSCC (full analysis set, FAS):
timeFrame: From 1st Jan 2021
measure: In patients with early and locally advanced stages of the disease (including all patients treated with curative intent):
timeFrame: From 1st Jan 2021
measure: In patients with recurrent or metastatic disease:
timeFrame: From 1st Jan 2021
Other outcomes:
measure: Exploratory objective
timeFrame: From 1st Jan 2021
Locations:
city: Madrid
country: Spain
facility: Savan Research S.L
Study officials:
affiliation: University Health Network and Mount Sinai Hospital
name: John Almeida
role: STUDY_CHAIR
affiliation: Ohio State University
name: Sujith Baliaga
role: STUDY_CHAIR
affiliation: Medsavana S.L
name: David Casadevall
role: STUDY_CHAIR
affiliation: National Cancer Centre, Singapore
name: Melvin Chua
role: STUDY_CHAIR
affiliation: University Hospital of Leipzig
name: Andreas Dietz
role: STUDY_CHAIR
affiliation: UPMC Hillman Cancer Center
name: Robert Ferris
role: STUDY_CHAIR
affiliation: Hopital Ángel H. Roffo de Buenos Aires
name: Raul Giglio
role: STUDY_CHAIR
affiliation: Stanford University
name: Chris Holsinger
role: STUDY_CHAIR
affiliation: M.D. Anderson Cancer Center
name: Kate Hutcheson
role: STUDY_CHAIR
affiliation: Institute of Head and Neck Studies and Education (InHANSE)
name: Husham Menhanna
role: STUDY_CHAIR
affiliation: Hospital HM Rosaleda
name: Pablo Parente
role: STUDY_CHAIR
affiliation: Queensland Institute of Medical Research (QIMR)
name: Sandro Porceddu
role: STUDY_CHAIR
affiliation: Medsavana S.L
name: Miren Taberna
role: PRINCIPAL_INVESTIGATOR
affiliation: CHUV Lausanne
name: Christian Simon
role: STUDY_CHAIR
References: