Metabolic and Immunological Phenotyping in Patients With Cancer

NCT04285242 | Recruiting

• 1 other identifier: MIPPaC
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cancer; Non-Hematologic Malignancy

Keywords

Cancer; Non-haematological

Outcome Measures

Primary Outcomes (1)

• Serum cortisol level

  Blood serum cortisol levels in weight losing and weight stable patients at baseline and Day 2

  Change from baseline serum cortisol level at Day 2

Study Arms (4)

Participants with Cancer - Group A

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

Other: Observational assessments

Healthy Volunteers - Group A

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

Other: Observational assessments

Healthy Volunteers - Group B

Assessments and observations for up to 2 days.

Other: Observational 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.

Other: Observational assessments

Interventions

Observational assessments OTHER

Clinical assessments

Healthy Volunteers - Group A; Healthy Volunteers - Group B; Participants with Cancer - Group A; Participants with Cancer - Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and Female participants who have cancer or are healthy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CCTU- Cancer Theme: lead

Study Sites (2)

Addenbrooke's Hospital, Cambridge University Hospitals Foundation Trust,

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

RECRUITING

Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, CB2 2QQ, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Neoplasms

Study Officials

• Claire Connell

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Early Phase Team Cambridge Cancer Trials Unit - Cancer Theme

CONTACT

01223216083; cuh.cctuep@nhs.net

Cambridge Cancer Trials Centre, Coordination Team

CONTACT

01223216083; cuh.cctu-ct@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Cambridge Clinical Trials Unit - Cancer Theme

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 26, 2020
• Study Start: December 7, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)