Official Title
Investigation Into the Transcriptomic and Functional Profile of SEPsis in ONCology Patients
Brief Title
Sepsis in Oncology Patients
Protocol ID
NCT06046677
Lead Sponsor
Royal Marsden NHS Foundation Trust
Brief Summary
The overall objective of this prospective observational study is to address the
significant knowledge gap that exists around the impact of immune dysfunction on the
development and survival from sepsis in patients with cancer. This proposal primarily
focuses on establishing the transcriptomic immune profiles of sepsis patients with a
background of cancer. This analysis will be complemented with in vitro functional
analyses, and in addition will commence a collection of genome-wide data, including a
focus on predicting white cell number and function in health. Uniquely, the investigators
propose to establish a robust link between these analyses: transcriptomic, in vitro, and
genome-wide, to enable them to comprehensively explore septic oncology patient 'immune
phenotypes' and effectively identify novel exploitable therapeutic pathways.
To this end, this project will collect, analyse and/or sequence DNA, RNA, leukocytes and
soluble materials from a cohort of oncology patients presenting to intensive care with
sepsis. This cohort will include all-comers with an oncological background but will also
focus on two core groups at high risk of sepsis where baseline samples can also be sought
prior to major immunosuppressive events in the cancer pathway. These are:
1. Oesophageal/upper gastrointestinal (GI) cancer patients prior to systemic anticancer
therapy initiation or surgery
2. Haematological malignancy patients prior to stem cell transplantation.
These sub-cohorts will provide a previously unexplored unique insight into the role of
pre-existing patient transcriptomic phenotypes.
Detailed Description
The specific aims will be to perform multi-modal parallel immune phenotyping to
determine:
- The transcriptomic (RNA) phenotypes (or 'signatures') of cancer patients with sepsis
- The association of these transcriptomic phenotypes with:
1. Leukocyte function in sepsis, as quantified by cell surface and functional
assays and plasma soluble mediator content
2. Pre-existing genomic determinants such as leukocyte numbers
3. Severity of, and outcome from, sepsis in oncology patients
Enrollment Count
180 participants
Eligibility Criteria
Sepsis cohort: Inclusion Criteria:
- Patients admitted to ICU with a diagnosis of sepsis as per 'Sepsis-3' definitions
with a SOFA score [REF] ≥2 secondary to infection from any source
- ≥18 years of age
- Written consent from patient, personal or professional consultee, or deferred
consent if none of the above available at admission
Sepsis cohort Exclusion Criteria:
• Death deemed imminent by the clinical team
Elective cohort inclusion criteria
- Patients undergoing elective major upper GI surgery (oesophago+/-gastrectomy) or
stem cell transplant for haematological malignancy
- ≥18 years of age
- Written consent from patient
Elective cohort exclusion criteria
• Limitations in place regarding provision of treatment and/or organ support e.g.,
palliative patients
Filters
Sepsis in Cancer Patients
NOT_YET_RECRUITING
ADULT
OLDER_ADULT