INDAGA-UK: GENE EXPRESSION PROFILING IN A VALIDATION COHORT OF LOCALLY ADVANCED AND RECURRENT/METASTATIC SALIVARY GLAND CANCERS

Sponsor

Royal Marsden NHS Foundation Trust (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06091878

Collaborator

(none)

250

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The INDAGA-UK trial is a retrospective, multi-centre observational study in participants with locally advanced and recurrent salivary gland to investigate t its molecular profiling, and to explore new prognostic and druggable markers. We will analyse samples and data from patients diagnosed with salivary gland cancer from 2013 - 2023. Subject and sample identification will occur over a 12-month period. Samples and data will be analysed over the next 12 months prior to study end.

Condition or Disease	Intervention/Treatment	Phase
Salivary Gland Cancer	Other: Observation

Study Design

Study Type:

Observational

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

GENE EXPRESSION PROFILING IN A VALIDATION COHORT OF LOCALLY ADVANCED AND RECURRENT/METASTATIC SALIVARY GLAND CANCERS: THE INDAGA-UK TRIAL

Anticipated Study Start Date :

Feb 1, 2024

Anticipated Primary Completion Date :

Jan 31, 2025

Anticipated Study Completion Date :

Jan 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1	Other: Observation Observational study, no intervention

Arm

Intervention/Treatment

Cohort 1

Other: Observation

Observational study, no intervention

Outcome Measures

Primary Outcome Measures

• Description of the molecular and genomic profile of locally advanced and recurrent-metastatic SGCs. [Time Frame: Through study completion, expected duration of 10 years]
• Description of the molecular and genomic profile of locally advanced and recurrent-metastatic SGCs.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Aged over 18
Histological diagnosis of salivary gland cancer (SGCs)
Availability of archival tissue (acceptable after 2013 up to present)
Ability to give informed consent (if applicable)* for retrieving histological specimen and preform molecular analysis *De-identified archival tissue from deceased patients will be collected as part of the study once REC approval is in place, if the patient was alive when the samples were taken and they are not part of the NHS opt out scheme.

Exclusion Criteria:

Different H&N cancer of other histology
Thyroid cancers

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Royal Marsden NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Royal Marsden NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT06091878

Other Study ID Numbers:

CCR5899

First Posted:

Oct 19, 2023

Last Update Posted:

Oct 19, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Salivary Gland Neoplasms

Study Results

No Results Posted as of Oct 19, 2023