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NCT06091878 Clinical Trial

Gene Expression Profiling in a Validation Cohort of Locally Advanced and Recurrent/Metastatic Salivary Gland Cancers

Salivary Gland Cancer Clinical Trial

— INDAGA-UK  

Official title:
Gene Expression Profiling in a Validation Cohort of Locally Advanced and Recurrent/Metastatic Salivary Gland Cancers: The INDAGA-UK Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06091878
Other study ID # CCR5899
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2024
Est. completion date January 31, 2026

Study information
Verified date May 2024
Source Royal Marsden NHS Foundation Trust
Contact Pablo Jimenez
Phone 02073528171
Email pablo.jimenez@rmh.nhs.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 250
Est. completion date January 31, 2026
Est. primary completion date January 31, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Aged over 18 2. Histological diagnosis of salivary gland cancer (SGCs) 3. Availability of archival tissue (acceptable after 2013 up to present) 4. 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: 1. Different H&N cancer of other histology 2. Thyroid cancers

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Observation
Observational study, no intervention

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Royal Marsden NHS Foundation Trust

Outcome
Type Measure Description Time frame Safety issue
Primary • Description of the molecular and genomic profile of locally advanced and recurrent-metastatic SGCs. • Description of the molecular and genomic profile of locally advanced and recurrent-metastatic SGCs. Time Frame: Through study completion, expected duration of 10 years
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