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Sepsis in Oncology Patients (SEPONC)

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ClinicalTrials.gov Identifier: NCT06046677
Recruitment Status : Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Sepsis in Cancer Patients Other: No intervention

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

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation Into the Transcriptomic and Functional Profile of SEPsis in ONCology Patients
Estimated Study Start Date : September 2023
Estimated Primary Completion Date : September 2026
Estimated Study Completion Date : September 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort Intervention/treatment
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.

Other: 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
Other: No intervention
No intervention




Primary Outcome Measures :
  1. Identification of circulating leukocyte transcriptomic phenotypes relating to mortality in sepsis patients with a background of cancer, (in comparison to those previously identified in non-immunosuppressed patients). [ Time Frame: end of trial (4 years) ]
    Identification of circulating leukocyte transcriptomic phenotypes relating to mortality in sepsis patients with a background of cancer, (in comparison to those previously identified in non-immunosuppressed patients).

  2. 28 day mortality [ Time Frame: end of recruitment (3 years) ]
    28 day mortality


Secondary Outcome Measures :
  1. Differences in the trajectory of transcriptomic phenotypes of patients admitted to ICU with sepsis, and how they relate to severity scorings and mortality/morbidity outcomes [ Time Frame: end of trial (4 years) ]
    how they relate to severity scorings and mortality/morbidity outcomes

  2. Differences in the trajectory of functional phenotypes of patients admitted to ICU with sepsis, and how they relate to severity scorings and mortality/morbidity outcomes [ Time Frame: end of trial (4 years) ]
    how they relate to severity scorings and mortality/morbidity outcomes

  3. Differences in the trajectory of genomic phenotypes of patients admitted to ICU with sepsis, and how they relate to severity scorings and mortality/morbidity outcomes [ Time Frame: end of trial (4 years) ]
    how they relate to severity scorings and mortality/morbidity outcomes

  4. Identification of differences in transcriptomic phenotypes between patient subgroups and on comparison to non-immunosuppressed sepsis patients. Comparison in length of stay measures and quality of life parameters [ Time Frame: end of trial (4 years) ]
    Comparison in length of stay measures and quality of life parameters

  5. Identification of differences in functional phenotypes between patient subgroups and on comparison to non-immunosuppressed sepsis patients. Comparison in length of stay measures and quality of life parameters [ Time Frame: end of trial (4 years) ]
    Comparison in length of stay measures and quality of life parameters

  6. Identification of differences in genomic phenotypes between patient subgroups and on comparison to non-immunosuppressed sepsis patients. Comparison in length of stay measures and quality of life parameters [ Time Frame: end of trial (4 years) ]
    Comparison in length of stay measures and quality of life parameters


Biospecimen Retention:   Samples With DNA
Buffy coat & PMBCs PAXgene RNA Plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

Patients who develop sepsis on ICU or require admission to ICU with sepsis will be identified and screened for enrolment by the research team at the Royal Marsden NHS Foundation Trust

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.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06046677


Locations
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United Kingdom
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW36JJ
Contact: Mark Brandon-Grove    02031865416    Mark.Brandon-Grove@rmh.nhs.uk   
Principal Investigator: Kate Tatham         
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
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Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT06046677    
Other Study ID Numbers: CCR5669
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes