This Protocol Focuses on the Factors That Influence Survival, the Development of Complications and the Quality of Life Based on the Treatment Received in the Group of Patients Suffering From Malignant Lesions of the Head and Neck

NCT07066878 | Not Yet Recruiting

• 1 other identifier: RETRO-HN
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol focuses on a retrospective, single-center analysis, analyzing the factors that influence survival as the main objective, and secondarily the development of complications and the quality of life based on the treatment received in the group of patients suffering from malignant lesions of the head and neck.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS) in Patients with Head and Neck Malignancies Treated with Curative Intent

  To assess overall survival in patients with malignant lesions of the head and neck (oral cavity, oropharynx, hypopharynx, larynx) undergoing curative treatment. Treatment modalities include major oncological surgery (alone or followed by adjuvant radiotherapy ± chemotherapy), definitive radiotherapy, definitive chemoradiotherapy, or induction chemotherapy followed by surgery or radiotherapy. Time Frame: 5 years from treatment initiation Unit of Measure: Time (months)

  5 years

Secondary Outcomes (1)

• Incidence and Severity of Treatment-Related Complications Classified by Clavien-Dindo Scale

  5 years

Other Outcomes (1)

• Health-Related Quality of Life (HRQoL) Measured by EORTC QLQ-H&N35

  5 years

Study Arms (4)

Oral cavity cancer patients

Procedure: treatment received in the group of patients suffering from malignant lesions of the head and neck.

Oropharyngeal cancer patiens

Procedure: treatment received in the group of patients suffering from malignant lesions of the head and neck.

Laryngeal/Hypopharyngeal cancer patients

Procedure: treatment received in the group of patients suffering from malignant lesions of the head and neck.

Major salivary glands cancer patients

Procedure: treatment received in the group of patients suffering from malignant lesions of the head and neck.

Interventions

treatment received in the group of patients suffering from malignant lesions of the head and neck. PROCEDURE

This protocol focuses on a retrospective, single-center analysis, analyzing the factors that influence survival as the main objective, and secondarily the development of complications and the quality of life based on the treatment received in the group of patients suffering from malignant lesions of the head and neck.

Laryngeal/Hypopharyngeal cancer patients; Major salivary glands cancer patients; Oral cavity cancer patients; Oropharyngeal cancer patiens

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 study population consists of patients who have been diagnosed with a malignant lesion of the head and neck district (specifically at the level of the oral cavity, oropharynx, larynx, hypopharynx or parotid gland) and underwent treatment with curative purpose (specifically the treatment may be surgical alone, surgical followed by radiotherapy treatment and possible chemotherapy, or radiotherapy, in possible association with chemotherapy in an upfront setting).

You may qualify if:

• Participant is willing and able to provide informed consent for study participation
• Age 18 years or older
• Histological diagnosis of head and neck cancer (any site, any histology)
• Treatment (surgical and/or radiotherapy and/or medical) received at San Raffaele Hospital between January 2014 and January 2024
• Consent for use of personal data for scientific purposes

You may not qualify if:

• Age under 18 years
• No histological diagnosis of head and neck cancer
• Treatment not performed at San Raffaele Hospital (surgical and/or radiotherapy and/or medical)
• Lack of signed consent for use of personal data for scientific purposes
• Severe comorbidities interfering with study participation or treatment protocols
• Inability to understand or provide informed consent due to cognitive or psychiatric disorders
• Concurrent participation in another clinical trial that may interfere with study outcomes

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Ospedale San Raffaele

Milan, Italy

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Andrea Galli

CONTACT

+390226438446; salerno.emilio@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 21, 2025
• First Posted: July 15, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 20, 2028
• Last Updated: July 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)