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NCT Number: NCT06046677

Sepsis in Oncology Patients

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.

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Key information

Conditions

Sepsis in Cancer Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Royal Marsden NHS Foundation Trust

London, SW36JJ, United Kingdom

Location contact

Kate Tatham

PRINCIPAL_INVESTIGATOR

Mark Brandon-Grove

CONTACT

[email protected]

02031865416

About this study

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:
  • Leukocyte function in sepsis, as quantified by cell surface and functional assays and plasma soluble mediator content
  • Pre-existing genomic determinants such as leukocyte numbers
  • Severity of, and outcome from, sepsis in oncology patients

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Registry information

Official study title

Investigation Into the Transcriptomic and Functional Profile of SEPsis in ONCology Patients

Acronym: SEPONC

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Sep 21, 2023
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.