Gene Expression Profiling in a Validation Cohort of Locally Advanced and Recurrent/Metastatic Salivary Gland Cancers (INDAGA-UK)

August 7, 2024 updated by: Royal Marsden NHS Foundation Trust

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Participants with a salivary gland cancer diagnosis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

October 13, 2023

First Submitted That Met QC Criteria

October 13, 2023

First Posted (Actual)

October 19, 2023

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR5899

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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