Metabolic and Immunological Phenotyping in Patients With Cancer

NCT ID: NCT04285242

Last Updated: 2024-02-02

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-07

Study Completion Date

2024-06-01

Brief Summary

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An observational study to investigate cachexia in participants with non-haematological cancer.

Detailed Description

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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.

Conditions

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Cancer Non-Hematologic Malignancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with Cancer - Group A

Assessments and observations for up to 40 days with one overnight hospital stay.

Observational assessments

Intervention Type OTHER

Clinical assessments

Healthy Volunteers - Group A

Assessments and observations for up to 2 days with one overnight hospital stay.

Observational assessments

Intervention Type OTHER

Clinical assessments

Healthy Volunteers - Group B

Assessments and observations for up to 2 days.

Observational assessments

Intervention Type OTHER

Clinical assessments

Participants with Cancer - Group B

Assessments and observations for up to 40 days, with most assessments and observations being optional and no overnight hospital stay.

Observational assessments

Intervention Type OTHER

Clinical assessments

Interventions

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Observational assessments

Clinical assessments

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CCTU- Cancer Theme

OTHER

Sponsor Role lead

Responsible Party

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CCTU- Cancer Theme

Cambridge Clinical Trials Unit - Cancer Theme

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Claire Connell

Role: PRINCIPAL_INVESTIGATOR

University of Cambridge

Locations

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Addenbrooke's Hospital, Cambridge University Hospitals Foundation Trust,

Cambridge, Cambridgeshire, United Kingdom

Site Status RECRUITING

Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Early Phase Team Cambridge Cancer Trials Unit - Cancer Theme

Role: CONTACT

01223216083

Cambridge Cancer Trials Centre, Coordination Team

Role: CONTACT

01223216083

Other Identifiers

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MIPPaC

Identifier Type: -

Identifier Source: org_study_id

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