IReC-Bio and IReC Registry

NCT05885490 | Not Yet Recruiting

• 1 other identifier: 5604
• Study Type: observational
• Target: 10,000,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

IReC is the world's first centre for recurrent head and neck cancers. We have the ambitious aim to create a centre of international excellence and set international standards in the curative treatment of recurrent head and neck cancers. One of IReC's key objectives is to develop a national research tissue bank to support laboratory and translational research. The cornerstone of translational research is a well-annotated biobank of cancer samples to explore and validate key research findings. The purpose of IReC-Bio is to support research into recurrent head and neck cancers. A central repository for the rarer recurrent cancers will allow the concentration of cases required in order to support translational research programmes. The overall aim is to facilitate research into understanding disease biology, identifying potentially curative treatments, and allow detailed investigations into the relationships between clinical, pathological and molecular characteristics and clinical outcomes. Combining the IReC Registry and Biobank gives us a comprehensive data and sample set which has never been created before for recurrent head and neck cancer. The aim is to have a national, and in the future international, resource of the study of recurrent head and neck cancer on a molecular and clinical level to support novel ways of treating rHNC.

Conditions

Head Cancer Neck

Outcome Measures

Primary Outcomes (1)

• Define the 2 year overall survival rates in all patients with rHNC

  2-year overall survival from date of diagnosis

  2 years

Secondary Outcomes (3)

• Define the 2-year disease-free (DFS), disease-specific (DSS), and local recurrence free survival (LRFS) rates in all patients with rHNC.

  2 years

• Define long-term functional outcomes after diagnosis of rHNC using gastrostomy and tracheostomy use as a surrogate marker up to 2 years after diagnosis with rHNC

  2 years

• Assess swallow with Performance Status Scale for head and neck cancer patients (PSS-HN) scores up to 2 years after diagnosis of rHNC.

  2 years

Study Arms (4)

Group 1

Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck - clinical data only

Group 2

Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck - clinical data and optional biobank sampling

Group 3

Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck - clinical data and optional quality of life data

Group 4

Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck - clinical data and optional quality of life data and optional biobank sampling

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck

You may qualify if:

• Aged over 18 at time of diagnosis.
• Confirmed clinical, radiological, and/ or histological diagnosis of residual, recurrent, or new primary malignant head and neck cancer arising from the nasopharynx, oropharynx, oral cavity, larynx, hypopharynx, sinonasal cavities, major salivary glands and thyroid gland.
• Any mucosal, salivary gland, and thyroid histological subtype
• Ability to give informed consent.
• Details of clinical follow-up available
• For IReC-BIO only:
• FFPE blocks(s) or fresh frozen tumour tissue available for collection
• Two or more tumour-containing blocks available from the same specimen
• For QoL Questionnaires only:
• Patients who have received a diagnosis of rHNC no earlier than 6 weeks prior to study entry

You may not qualify if:

• Recurrent cutaneous (e.g., SCC, melanoma), sarcomatous, and lymphatic or haematological (e.g. lymphoma) malignancies of the head and neck
• For IReC-BIO only:
• FFPE tumour samples contain insufficient tumour sample for analysis.
• Insufficient clinical details available
• For QoL Questionnaires only:
• Patients who have received a diagnosis of rHNC more than 6 weeks prior to study entry

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Biospecimen

Retention: SAMPLES WITH DNA

Surplus tumour tissue and an optional EDTA blood sample will be collected

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: June 2, 2023
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2050
• Study Completion (Estimated): December 1, 2050
• Last Updated: February 10, 2026

Record last verified: 2026-02