Salivary Gland CancerINDAGA-UKNCT06091878
Gene Expression Profiling in a Validation Cohort of Locally Advanced and Recurrent/Metastatic Salivary Gland Cancers
An observational study of Salivary Gland Cancer, run by Royal Marsden NHS Foundation Trust.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Salivary Gland Cancer
- What is being tested?
- Observation
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 31 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Participants with a salivary gland cancer diagnosis
Who may be able to join
- 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.
Who cannot join
- Different H\&N cancer of other histology
- Thyroid cancers
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Salivary Gland Cancer
- Being tested
- Observation
- Medical subject headings
- Salivary Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observational study, no intervention
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
Measured: Time Frame: Through study completion, expected duration of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Sep 2024 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salivary Gland CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091878
- Sponsor's protocol ID
- CCR5899
- Acronym
- INDAGA-UK
- Status last verified
- Aug 2024
- First submitted
- 13 Oct 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression Profiling in a Validation Cohort of Locally Advanced and Recurrent/Metastatic Salivary Gland Cancers: The INDAGA-UK Trial
- ClinicalTrials.gov ID
- NCT06091878
- Acronym / sponsor ID
- INDAGA-UK / CCR5899
- Conditions
- Salivary Gland Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Observation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants with a salivary gland cancer diagnosis
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Different H\&N cancer of other histology
- Thyroid cancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationObservational study, no intervention | Other | Cohort 1 |
Primary outcome
• 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Salivary Gland Cancer, run by Royal Marsden NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pablo Jimenez (02073528171, pablo.jimenez@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.