Understanding immunE-related toXicities by multifACeT Profiling

Oncology Clinical Trial

— EXACT  

Official title:

EXACT - Understanding immunE-related toXicities by multifACeT Profiling

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05331066
• Other study ID #: 5064
• Status: Recruiting
• Start date: April 6, 2022
• Est. completion date: April 6, 2028

Study information

• Verified date: March 2024
• Source: Royal Marsden NHS Foundation Trust
• Contact: Laura Boddy
• Phone: 020 7352 8171
• Email: exact[@]rmh.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A prospective observational cohort study of patients undergoing CPI therapy in which translational research is the fundamental aspect of the study.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 6, 2028
• Est. primary completion date: April 6, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Neoplasms
• Oncology

Locations

Country	Name	City	State
United Kingdom	Royal Marsden NHS Foundation Trust	Chelsea	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact on patients quality of life using patient questionnaires	• Explore the quality-of-life impact on patients enrolled in longitudinal multi-facet disease profiling and in patients who develop irAEs.	60 months
Primary	Patients who experience irAEs	To determine the proportion of patients who experience irAEs during treatment with CPI.	36 months
Secondary	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).	60 months
Secondary	Time to development of irAEs	To determine time to clinical development of irAEs during treatment with CPI.	36 months
Secondary	Proportion of patients experiencing irAEs	• To determine the proportion of patients experiencing any irAE during long-term follow up, post treatment.	60 months