Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
180 participants
OBSERVATIONAL
2023-09-30
2027-09-30
Brief Summary
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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.
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Detailed Description
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* 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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Sepsis cohort
Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.
Organ dysfunction can be identified as an acute change in total SOFA score ≥2 points consequent to the infection.
No intervention
No intervention
Elective cohort
Elective pre-operative upper GI surgical patients or elective stem cell transplant patients will be consented and enrolled at baseline, immediately prior to these procedures. If they go on to develop sepsis within 60 days of their surgery, they will go on to be sampled as per the sepsis cohort
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
* ≥18 years of age
* Written consent from patient, personal or professional consultee, or deferred consent if none of the above available at admission
* Patients undergoing elective major upper GI surgery (oesophago+/-gastrectomy) or stem cell transplant for haematological malignancy
* ≥18 years of age
* Written consent from patient
Exclusion Criteria
• Limitations in place regarding provision of treatment and/or organ support e.g., palliative patients
18 Years
ALL
No
Sponsors
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Royal Marsden NHS Foundation Trust
OTHER
Responsible Party
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Locations
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The Royal Marsden NHS Foundation Trust
London, , United Kingdom
Countries
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Facility Contacts
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Other Identifiers
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CCR5669
Identifier Type: -
Identifier Source: org_study_id
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