OncologyEXACTNCT05331066
Understanding immunE-related toXicities by multifACeT Profiling
An observational study of Oncology, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
A prospective observational cohort study of patients undergoing CPI therapy in which translational research is the fundamental aspect of the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Apr 2022to 6 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: The study aims to enroll and obtain samples of investigational interest from 200 patients with a confirmed diagnosis of any form of solid malignancy with a clinical indication and appropriate treatment plan to commence immune checkpoint inhibitor therapy.
Who may be able to join
- Written informed consent
- Age 18 years or older
- Confirmed diagnosis of any form of solid malignancy with a clinical indication and appropriate treatment plan to commence immune checkpoint inhibitor therapy
Who cannot join
- Medical or psychological condition that would preclude informed consent
- Planned participation in a drug trial receiving investigational agents
- Subjects who have previously commenced immune checkpoint inhibitor therapy prior to study entry.
- Subjects unable to comply with the study or sample schedule.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Arjun Modi contact
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden NHS Foundation Trust
Chelsea, London, SW3 6JJ
Dilruba Kabir, 02073528171, dilruba.kabir@rmh.nhs.uk
About this study
Official title: EXACT - Understanding immunE-related toXicities by multifACeT Profiling
A prospective observational cohort study of patients undergoing CPI therapy in which translational research is the fundamental aspect of the study.
Read the detailed description
The study aims to enroll and obtain samples of investigational interest from 200 patients over a 36-month recruitment period. Blood and/ or stool samples will be taken at baseline, in context of irAE development / during CPI treatment and during follow-up. Skin samples may also be taken upon development of organspeciifc irAEs.
Further assessments at baseline or during the course of or following treatment will be conducted in accordance with standard institutional practice and will be clinically driven. Clinical data, samples and results from archival, current or prospective diagnostic or therapeutic procedures will be used for research purposes within EXACT.
IrAE clinical monitoring will be conducted in accordance with standard institutional practice and will be clinically driven.
- Conditions
- Oncology
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients who experience irAEs
To determine the proportion of patients who experience irAEs during treatment with CPI.
Measured: 36 months
Secondary outcomes (3)
Biological and clinical characteristics
To profile biological and clinical characteristics at baseline and during treatment with CPI to detect indicators predictive of the development of immunotherapy-related adverse events (irAEs).
Measured: 60 months
Time to development of irAEs
To determine time to clinical development of irAEs during treatment with CPI.
Measured: 36 months
Proportion of patients experiencing irAEs
- To determine the proportion of patients experiencing any irAE during long-term follow up, post treatment.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start6 Apr 2022
- Primary completion6 Apr 2028 (estimated)
- Study completion6 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samra Turajlic, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331066
- Sponsor's protocol ID
- 5064
- Acronym
- EXACT
- Status last verified
- Sep 2025
- First submitted
- 8 Apr 2022
- Last updated
- 1 Oct 2025
- 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 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXACT - Understanding immunE-related toXicities by multifACeT Profiling
- ClinicalTrials.gov ID
- NCT05331066
- Acronym / sponsor ID
- EXACT / 5064
- Conditions
- Oncology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 6 Apr 2028 (estimated)
- Study completion
- 6 Apr 2028 (estimated)
- First posted
- 15 Apr 2022 (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.
A prospective observational cohort study of patients undergoing CPI therapy in which translational research is the fundamental aspect of the study.
Detailed description
The study aims to enroll and obtain samples of investigational interest from 200 patients over a 36-month recruitment period. Blood and/ or stool samples will be taken at baseline, in context of irAE development / during CPI treatment and during follow-up. Skin samples may also be taken upon development of organspeciifc irAEs.
Further assessments at baseline or during the course of or following treatment will be conducted in accordance with standard institutional practice and will be clinically driven. Clinical data, samples and results from archival, current or prospective diagnostic or therapeutic procedures will be used for research purposes within EXACT.
IrAE clinical monitoring will be conducted in accordance with standard institutional practice and will be clinically driven.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study aims to enroll and obtain samples of investigational interest from 200 patients with a confirmed diagnosis of any form of solid malignancy with a clinical indication and appropriate treatment plan to commence immune checkpoint inhibitor therapy.
Key inclusion criteria (3 listed)
- Written informed consent
- Age 18 years or older
- Confirmed diagnosis of any form of solid malignancy with a clinical indication and appropriate treatment plan to commence immune checkpoint inhibitor therapy
Key exclusion criteria (4 listed)
- Medical or psychological condition that would preclude informed consent
- Planned participation in a drug trial receiving investigational agents
- Subjects who have previously commenced immune checkpoint inhibitor therapy prior to study entry.
- Subjects unable to comply with the study or sample schedule.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patients who experience irAEs
Time frame: 36 months
To determine the proportion of patients who experience irAEs during treatment with CPI.
3 secondary outcomes
Biological and clinical characteristics
Time frame: 60 months
Time to development of irAEs
Time frame: 36 months
Proportion of patients experiencing irAEs
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- 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.
Arjun Modi contact
Samra Turajlic principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Boddy (020 7352 8171, exact@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients who experience irAEs (time frame: 36 months). 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 1 Oct 2025.