NCT02832102

Brief Summary

The purpose of this study is to determine new multiscale signatures for the prediction of head and neck cancer (HNC) patients disease outcome, in particular for advanced stage (stage III, IV) human papillomavirus (HPV) negative patients and to validate prognostic models for overall survival.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Typical duration for all trials

Geographic Reach
3 countries

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

3 years

First QC Date

June 1, 2016

Last Update Submit

July 11, 2016

Conditions

Cancer of Head and Neck

Keywords

prognostic modellingradiomicsclinical decision support systembig data analysismultiscale prognostic signaturespatient-clinician co-decision tools

Outcome Measures

Primary Outcomes (1)

  • Realizes and validates an Integrated Decision Support System (BD2Decide platform)

    The primary endpoint of this study is the accuracy of the prediction of prognosis based on the BD2Decide platform compared to Tumor Node Metastasis staging (in a population consisting of patients with different subtypes of head and neck cancer).

    through study completion, an average of 3 year

Secondary Outcomes (2)

  • Improved Quality of Life

    baseline, month 6, month 18, month 24 after primary treatment

  • Assess survival time

    at 2, 3 and 5 years

Study Arms (2)

Retrospective cohort

A total of 1000 SCCHN patients will be enrolled in a retrospective observational study treated in the period 2008-2014. Standard treatment of SCCHN patients The patients will be managed as foreseen by best clinical practice and international guidelines for SCCHN.

Procedure: Standard treatment of SCCHN patients

Prospective cohort

A total of 450 SCCHN patients will be enrolled in a study. Each participating Center will select consecutive patients according to the selection criteria (inclusion/exclusion criteria) for one year and will be followed up for two years or more. Standard treatment of SCCHN patients: patients will be administered current best clinical practice treatments.

Procedure: Standard treatment of SCCHN patients

Interventions

Standard treatment of SCCHN patientsPROCEDURE

The interventions may include surgery, radiotherapy, chemotherapy or combined therapies, as recommended by best practice and international guidelines.

Prospective cohortRetrospective cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospective study cohort: A total of 450 SCCHN patients Stage III and IV, followed up for 18-24 months or more. Retrospective study cohort: A total of 1000 SCCHN patients Stage III and IV, diagnosed between year 2008 and 2014.

You may qualify if:

  • Signed informed consent
  • Histologically confirmed diagnosis of oral cavity, oropharynx, larynx, hypopharynx squamous cell carcinoma
  • Clinical stage III and IV
  • Patient candidate for curative treatment: ± surgery ± radiotherapy ± chemotherapy
  • Adequate archival pre-treatment tumor specimen available (FFPE macrodissected sections)
  • Availability of baseline diffusion-weighted imaging (DWI) - Magnetic Resonance Imaging (MRI) acquisition (non-TRACE ) with more than 3 b-values (ranging from 0 (included) to 1000 s/mm2), and a field map acquisition.
  • MRI images, T1 and T2 weighted, (slice thickness lower than 3 mm), head and neck in a single volume, and/or CT scan of the head and neck performed with contiguous cuts of 2-3 mm or less in slice thickness with i.v. contrast
  • Male or female ≥ 18 years old

You may not qualify if:

  • Any previous haed and neck cancer.
  • Patients with previous malignancies in the last 5 years before treatment for head and neck cancer, with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin.
  • Any previous malignancy that was treated with surgery and or radiation of the head and neck region.
  • Histological type other than head and neck squamous cell cancer (nasopharynx, salivary glands and sinus nasal cancer are excluded).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Heinrich-Heine Universitaet Dusseldorf, Dept. of Othorinolaryngology, HHU

Düsseldorf, 40225, Germany

RECRUITING

Fondazione Irccs Istituto Dei Tumori Milano

Milan, MI, 20133, Italy

RECRUITING

Azienda Ospedaliero Universitaria di Parma

Parma, PR, 43100, Italy

RECRUITING

Stichting VU/VUmc

Amsterdam, 1081 HV, Netherlands

ACTIVE NOT RECRUITING

Maastricht Radiation Oncology MAASTRO Clinic

Maastricht, 6229 ET, Netherlands

RECRUITING

Related Publications (2)

  • Cavalieri S, Brakenhoff RH, Leemans CR, Hoebers FJP, Poli T, Scheckenbach K, Iacovelli NA, Franceschini M, Orlandi E, Licitra L, De Cecco L. Prognostic gene expression signatures for HPV-negative head and neck squamous cell carcinoma. Radiother Oncol. 2025 Jul;208:110900. doi: 10.1016/j.radonc.2025.110900. Epub 2025 Apr 17.

    PMID: 40252811DERIVED

  • Cavalieri S, Serafini MS, Carenzo A, Canevari S, Brakenhoff RH, Leemans CR, Nauta IH, Hoebers F, van den Hout MFCM, Scheckenbach K, Hoffmann TK, Ardighieri L, Poli T, Quattrone P, Locati LD, Licitra L, De Cecco L. Clinical Validity of a Prognostic Gene Expression Cluster-Based Model in Human Papillomavirus-Positive Oropharyngeal Carcinoma. JCO Precis Oncol. 2021 Oct 27;5:PO.21.00094. doi: 10.1200/PO.21.00094. eCollection 2021.

    PMID: 34738049DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

FFPE tumor specimens

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Tito Poli, MD, PHD

    Azienda Ospedaliero-Universitaria di Parma

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tito Poli, MD, PhD

CONTACT

+39052170tito.poli@unipr.it

Lisa Licitra, MD, PhD

CONTACT

+39 022390lisa.licitra@istitutotumori.mi.it

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 1, 2016

First Posted

July 14, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

July 14, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will share

Patients' data are pseudonymised and stored in a shared Case Report Form (CRF) for data analysis

Locations

NL(2)DE(1)IT(2)