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Metabolic and Immunological Phenotyping in Patients With Cancer (MIPPaC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04285242
Recruitment Status : Recruiting
First Posted : February 26, 2020
Last Update Posted : January 24, 2022
Sponsor:
Information provided by (Responsible Party):
CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust

Study Description
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Brief Summary:
An observational study to investigate cachexia in participants with non-haematological cancer.

Condition or disease Intervention/treatment
Cancer Non-Hematologic Malignancy Other: Observational assessments

Detailed Description:
A single-centre, non-randomised, observational study. This study will investigate the systemic metabolic and immunological changes that occur in cachexia. The aim is to better understand the mechanism(s) underlying weight loss in people with non-haematological cancer. This will help to facilitate future research to generate treatments to reverse weight loss and improve outcomes.
Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Metabolic and Immunological Phenotyping in Patients With Cancer
Actual Study Start Date : December 7, 2021
Estimated Primary Completion Date : August 10, 2023
Estimated Study Completion Date : September 19, 2023
Groups and Cohorts
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Group/Cohort Intervention/treatment
Participants with Cancer
Assessments and observations for up to 40 days with one overnight hospital stay.
 Other: Observational assessments
Clinical assessments
Healthy Volunteers - Group A
Assessments and observations for up to 2 days with one overnight hospital stay.
 Other: Observational assessments
Clinical assessments
Healthy Volunteers - Group B
Assessments and observations for up to 2 days.
 Other: Observational assessments
Clinical assessments


Outcome Measures
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Primary Outcome Measures :
  1. Serum cortisol level [ Time Frame: Change from baseline serum cortisol level at Day 2 ]
    Blood serum cortisol levels in weight losing and weight stable patients at baseline and Day 2


Biospecimen Retention:   Samples With DNA
Blood samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Male and Female participants who have cancer or are healthy
Criteria

Inclusion Criteria:

  • Have given written informed consent to participate
  • Be aged 18 years or over at the time of signing the informed consent form
  • Have a histological or cytological diagnosis of a non-haematological cancer
  • Are willing and able to comply with study procedures and visits

Exclusion Criteria:

  • Active infection, as determined by the investigator based on clinical symptoms and / or fever and / or requirement for antibiotics
  • Current treatment with chemotherapy, oral steroids or other immunosuppressive drugs (within 7 days of baseline investigations or during the study phase)
  • Significant acute, chronic or psychiatric condition or laboratory abnormality which in the judgment of the investigator would place the patient at undue risk or interfere with the study.
  • Intolerance to dairy products
  • Women, who are pregnant, plan to become pregnant or are lactating
Contacts and Locations
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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): NCT04285242


Contacts
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Contact: Early Phase Team Cambridge Cancer Trials Unit - Cancer Theme 01223216083 cctuep@addenbrookes.nhs.uk
Contact: Cambridge Cancer Trials Centre, Coordination Team 01223216083 cctu.cancer@addenbrookes.nhs.uk

Locations
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United Kingdom
Addenbrooke's Hospital, Cambridge University Hospitals Foundation Trust, Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, England, United Kingdom, CB2 2QQ
Sponsors and Collaborators
CCTU- Cancer Theme
Investigators
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Principal Investigator: Claire Connell University of Cambridge
More Information
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Responsible Party: CCTU- Cancer Theme, Cambridge Clinical Trials Unit - Cancer Theme, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04285242    
Other Study ID Numbers: MIPPaC
First Posted: February 26, 2020    Key Record Dates
Last Update Posted: January 24, 2022
Last Verified: January 2022
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
Keywords provided by CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust:
Cancer
Non-haematological
Additional relevant MeSH terms:
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Neoplasms