CancerMIPPaCNCT04285242
Metabolic and Immunological Phenotyping in Patients With Cancer
An observational study of Cancer and Non-Hematologic Malignancy, run by CCTU- Cancer Theme at 2 sites in United Kingdom.
Trial summary
An observational study to investigate cachexia in participants with non-haematological cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Non-Hematologic Malignancy
- What is being tested?
- Observational assessments
- How many people
- 80 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 7 Dec 2021to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male and Female participants who have cancer or are healthy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Addenbrooke's Hospital, Cambridge University Hospitals Foundation Trust,
Cambridge, Cambridgeshire, CB2 0QQ
- Recruiting
Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, CB2 2QQ
About this study
An observational study to investigate cachexia in participants with non-haematological cancer.
Read the 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.
- Conditions
- Cancer, Non-Hematologic Malignancy
- Being tested
- Observational assessments
- Keywords
- Cancer, Non-haematological
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational assessmentsOther
Clinical assessments
| Study group | Role | What they receive |
|---|---|---|
| Participants with Cancer - Group A | Assessments and observations for up to 40 days with one overnight hospital stay. Receives: Other: Observational assessments | |
| Healthy Volunteers - Group A | Assessments and observations for up to 2 days with one overnight hospital stay. Receives: Other: Observational assessments | |
| Healthy Volunteers - Group B | Assessments and observations for up to 2 days. Receives: 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. Receives: Other: Observational assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum cortisol level
Blood serum cortisol levels in weight losing and weight stable patients at baseline and Day 2
Measured: Change from baseline serum cortisol level at Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start7 Dec 2021
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CCTU- Cancer Theme
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Claire Connell, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285242
- Sponsor's protocol ID
- MIPPaC
- Acronym
- MIPPaC
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2020
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Immunological Phenotyping in Patients With Cancer
- ClinicalTrials.gov ID
- NCT04285242
- Acronym / sponsor ID
- MIPPaC / MIPPaC
- Conditions
- Cancer, Non-Hematologic Malignancy
- Keywords
- Cancer, Non-haematological
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- CCTU- Cancer ThemeUniversity, hospital or other
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An observational study to investigate cachexia in participants with non-haematological cancer.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Participants with Cancer - Group A | – | Other: Observational assessmentsAssessments and observations for up to 40 days with one overnight hospital stay. |
| Healthy Volunteers - Group A | – | Other: Observational assessmentsAssessments and observations for up to 2 days with one overnight hospital stay. |
| Healthy Volunteers - Group B | – | Other: Observational assessmentsAssessments and observations for up to 2 days. |
| Participants with Cancer - Group B | – | Other: Observational assessmentsAssessments and observations for up to 40 days, with most assessments and observations being optional and no overnight hospital stay. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male and Female participants who have cancer or are healthy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational assessmentsClinical assessments | Other | Healthy Volunteers - Group A, Healthy Volunteers - Group B, Participants with Cancer - Group A, Participants with Cancer - Group B |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Connell principal investigator
University of Cambridge
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Non-Hematologic Malignancy, run by CCTU- Cancer Theme at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Early Phase Team Cambridge Cancer Trials Unit - Cancer Theme (01223216083, cuh.cctuep@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum cortisol level (time frame: Change from baseline serum cortisol level at Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.