Colorectal CancerCLiFFNCT03562234
The CLiFF Study: Change in Liver Function and Fat in Pre-operative Chemotherapy for Colorectal Liver Metastases
An observational study of Colorectal Cancer and Liver Metastasis Colon Cancer, run by University of Manchester at 1 site in United Kingdom.
Trial summary
The CLiFF Study will assess changes in liver function and liver fat in patients with colorectal liver metastases (CLM) undergoing pre-operative chemotherapy before liver resection. There will be no change to the standard treatment for CLM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Liver Metastasis Colon Cancer, Chemotherapy Effect
- What is being tested?
- MR and LiMAx
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Oct 2018to Apr 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with documented resectable or potentially resectable colorectal cancer liver metastases planned to undergo pre-operative standard care chemotherapy at the Christie NHS Foundation Trust,
Who may be able to join
- Histologically verified adenocarcinoma of the colon or rectum with radiological evidence of potentially resectable liver metastases, with no evidence of unresectable non-hepatic metastatic disease.
- Pre-operative chemotherapy planned using Oxaliplatin-based chemotherapy regimen (including FOLFOX, XELOX and OXCAP regimens
- Age greater than or equal to 18 years
- WHO (World Health Organisation) performance status 0, 1 or 2
- Adequate haematological and hepatic function defined by: Hb ³ 10g/dl, WBC ³ 3.0 x 109/L, ANC ³ 1.5 x 109/L, platelet count ³ 100,000/ mm3, total bilirubin < 30 mmol/L, serum AST, ALT and alkaline phosphatase 5 x upper limit of normal
- Renal function with creatinine clearance 60 mls/min (for full dose) or 30 ml/min for 50%-dose oxaliplatin
- Patients must have given written informed consent
- Any woman of childbearing potential must have a negative pregnancy test prior to enrolment in to the study and must take adequate precautions to prevent pregnancy during treatment
Who cannot join
- Presence of a medical or psychiatric condition that impairs their ability to give informed consent
- Presence of any other serious uncontrolled medical conditions
- Evidence of unresectable non-hepatic metastatic disease
- Pregnant or lactating women. Adequate contraception must be used in fertile patients
- Contra-indications to MR scanning
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Christie NHS Foundation Trust
Manchester, Greater Manchester, M20 4NX
Kat L Parmar, MBChB FRCS, 07817296021, Kat.Parmar@manchester.ac.uk
Kat L Parmar, MBChB FRCS
About this study
Official title: The CLiFF Study: A Prospective Evaluation of Change in Liver Function and Fat in Patients With Colorectal Liver Metastases Undergoing Pre-operative Chemotherapy
The CLiFF Study will assess changes in liver function and liver fat in patients with colorectal liver metastases (CLM) undergoing pre-operative chemotherapy before liver resection. There will be no change to the standard treatment for CLM. The change in liver fat will be assessed using novel magnetic resonance techniques and the change in liver function will be measured using a newly-developed fully-licensed breath test to give the most accurate measure of liver function possible.
Understanding if these changes are related or reversible will help to understand the relationship between obesity and cancer. This is an important issue, as obesity is now the second most common cause of cancer worldwide.
Read the detailed description
Obesity is the second most common cause of cancer in the United Kingdom (UK) and bowel cancer is the third most common cancer. Obesity can increase both the chance of developing bowel cancer and it's progression. Increased liver fat is likely to be important in this process, but it is not easy to measure liver fat accurately without invasive biopsies.
Chemotherapy is often used to treat colorectal liver metastases before surgery. It is known that chemotherapy can increase liver fat and can reduce liver function, however it is not known if these changes are either reversible or related.
Understanding the relationship of these changes and their potential reversibility could help plan the best treatment for colorectal liver metastases and to understand the wider relationship between obesity and cancer.
A Manchester cancer research team have developed new MR (magnetic resonance) scan techniques which are better able to measure liver fat levels without needing invasive biopsies. The researchers also have a newly-developed fully-licensed machine which can measure liver function more accurately by using a breath test (LiMAx test), donated to the team for this study by the manufacturer, Humedics GmbH.
Patients undergoing pre-operative chemotherapy for CLM at the Christie Hospital will be invited to join this study. Their liver fat content will be measured using the new MR techniques and their liver function measured using the LiMAx test. These will be measured before chemotherapy, during chemotherapy, and after they finish. Their normal treatment will remain unchanged. When they undergo liver surgery, the section of removed liver will be analysed for fatty changes to help confirm that the MR scans are accurate.
- Being tested
- MR, LiMAx
- Keywords
- Colorectal Cancer, Colorectal Liver Metastases, Obesity Related Cancer, Chemotherapy
- Medical subject headings
- Colorectal Neoplasms, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRDiagnostic test
Liver fat (measured as a percentage - hepatic fat fraction) will be measured by Magnetic Resonance imaging
LiMAxDiagnostic test
Liver function will be measured using the relatively new CE licenced non-invasive LiMAx (Liver Maximum Capacity) test device, manufactured by Humedics GmbH
| Study group | Role | What they receive |
|---|---|---|
| Pre-op Chemotherapy for CLM: MR & LiMAx | Patients undergoing pre-operative chemotherapy for colorectal liver metastases being treated at the Christie NHS (National Health Service) Foundation Trust.
No intervention - participants will continue with standard care. Observation of changes in liver fat and liver function measured by MR (Magnetic Resonance) scan and LiMAx test (Maximum liver capacity). Receives: Diagnostic Test: MR; Diagnostic Test: LiMAx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liver fat (hepatic fat fraction)
Change in liver fat (measured as a percentage using MR imaging - the hepatic fat fraction) comparing the baseline pre-chemotherapy measurement at Week 1 with measurements at cessation of chemotherapy (Week 13) and 8 weeks after cessation of chemotherapy (Week 21). The expectation based on relevant literature is that chemotherapy will lead to potentially reversible higher levels of liver fat. Therefore the liver fat measurement (hepatic fat fraction) should be higher at week 13 than at week 1, and if this change is reversible, the liver fat should decrease during the eight weeks following cessation of chemotherapy, resulting in the measurement at Week 21 being lower than week 13.
Measured: 21 weeks
Change in liver function
Change in liver function measured by LiMAx test (Liver Maximum Capacity), comparing the baseline pre-chemotherapy measurement at week 1 with a measurement mid-chemotherapy (week 7), a measurement at cessation of chemotherapy (Week 13) and a measurement 8 weeks after cessation of chemotherapy (week 21). The expectation from relevant literature is that chemotherapy should cause a reversible deterioration in liver function, therefore the measurement at Week 7 should be lower than week 1, with the measurement at Week 13 then being lower again than week 7. If this deterioration in liver function is reversible, potentially within 8 weeks of stopping chemotherapy as suggested in the literature, then the measurement at Week 21 should be higher than both week 7 and week 13.
Measured: 21 weeks
Secondary outcomes (11)
Change in liver enzymes
Change in liver enzymes as measured by routinely collected blood biochemistry investigations taken at baseline (Week 1), during chemotherapy (weeks 3, 5, 7, 9 and 11) at cessation of chemotherapy (week 13), at pre-operative assessment (Week 21) and at post-operative outpatient review (Week 28). The expectation is that if any chemotherapy-related deterioration in liver function is detected by a change in liver enzymes, it will not be detected as well as by the LiMAx assessment, therefore any change from baseline values should be less substantial.
Measured: 28 weeks
Change in body mass index (BMI)
BMI measurements taken from routine physical examinations at baseline (Week 1), during chemotherapy (Weeks 3, 5, 7, 9 and 11), at cessation of chemotherapy (Week 13) and at pre-operative assessment (Week 21). Any change in BMI will be compared to the change in liver fat as assessed by MR scan, to establish if an increase in liver fat is related to an overall change in BMI rather than a localised effect of chemotherapy.
Measured: 21 weeks
Change in CT-derived anthropometric measurements 1 - Visceral Adipose Tissue (VAT)
Anthropometric measurements as taken from routine Computed Tomography (CT) scans performed in at baseline (Week 1), cessation of chemotherapy (Week 13) and pre-operative assessment (Week 21). No additional CT scans will be performed other than those indicated by routine standard care. Visceral adipose tissue (VAT) measurements will be calculated from these routine CT scans by measuring the intra-abdominal fat in a single tomographic slice at the L4-L5 level, expressed in centimeters squared. Any change in the VAT measurement will be compared to the change in liver fat as determined by MR scan, in order to assess if any change in liver fat is related to overall changes in body composition rather than being a localised effect on the liver. The change in liver fat will either follow a similar pattern to the change in VAT if it is a generalised change in body composition, or it will be unrelated if it increases via a different mechanism.
Measured: 21 weeks
Change in CT-derived anthropometric measurements 2 - Subcutaneous Adipose Tissue (SAT)
Anthropometric measurements as taken from routine Computed Tomography (CT) scans performed in at baseline (Week 1), cessation of chemotherapy (Week 13) and pre-operative assessment (Week 21). No additional CT scans will be performed other than those indicated by routine standard care. Subcutaneous adipose tissue (SAT) measurements will be calculated from these routine CT scans by measuring the subcutaneous fat in a single tomographic slice at the L4-L5 level, expressed in centimeters squared. Any change in the SAT measurement will be compared to the change in liver fat as determined by MR scan, in order to assess if any change in liver fat is related to overall changes in body composition rather than being a localised effect on the liver. The change in liver fat will either follow a similar pattern to the change in SAT if it is a generalised change in body composition, or it will be unrelated if it increases via a different mechanism.
Measured: 21 weeks
Change in CT-derived anthropometric measurements 3 - Muscle Mass
Anthropometric measurements as taken from routine Computed Tomography (CT) scans performed in at baseline (Week 1), cessation of chemotherapy (Week 13) and pre-operative assessment (Week 21). No additional CT scans will be performed other than those indicated by routine standard care. Muscle mass measurements will be calculated from these routine CT scans by measuring the skeletal muscle mass in a single tomographic slice at the L4-L5 level, expressed in centimeters squared. Any change in the muscle mass measurement will be compared to the change in liver fat as determined by MR scan, in order to assess if any change in liver fat is related to overall changes in body composition rather than being a localised effect on the liver. The change in liver fat will either follow a similar pattern to the change in muscle mass if it is a generalised change in body composition, or it will be unrelated if it increases via a different mechanism.
Measured: 21 weeks
Digital histological quantification of hepatic fat
Hepatic fat fraction as measured by routine histology reporting of operative specimen following surgery to resect liver metastases. This measurement will be compared to the hepatic fat fraction at the Week 21 MR scan in order to assess accuracy in non-invasive assessment of liver fat.
Measured: 28 weeks
NAS-CRN grade of steatosis (Non-Alcoholic Steatohepatitis Activity Score Clinical Research Network)
The Non-Alcoholic Steatohepatitis Clinical Research Network (NASH CRN) have published a NASH activity score (NAS-CRN score). The score assesses the severity of Non-Alcoholic Fatty Liver Disease and is performed during routine histology reporting on liver specimens. It uses the sum of three components to give a total of 0-8 points: 1) Steatosis (0: < 5%; 1: 5 - 33%; 2: 34 - 66%; 3: > 66%), 2) lobular inflammation (0: none; 1: < 2 foci/20x field; 2: 2 - 4 foci/20x field; 3: > 4 foci/20x field), and 3) ballooning degeneration (0: none; 1: few; 2: many). This objective score includes an assessment of the percentage liver steatosis in the sample, representative of overall percentage liver fat. This steatosis score will be compared to the pre-operative measurement of liver fat as determined by MR scan, in order to cross-check the accuracy of this non-invasive technique for the assessment of liver fat.
Measured: 28 weeks
Post-operative 30 day mortality
Post-operative 30 day mortality as yes/no, as routinely collected during standard care.
Measured: 28 weeks
Post-operative 30 day complications using Clavien-Dindo classification
Post-operative 30 day complications as routinely measured during standard care using the standardised Clavien-Dindo classification. This is a standardised grading system for post-operative complications graded by severity from 1 to 5. 1 represents the most minor complications and 5 represents the most severe complication (death).
Measured: 28 weeks
Post-operative 30 day complications using the Comprehensive Complication Index (CCI)
Post-operative 30 day complications as routinely measured during standard care using the Comprehensive Complication Index (CCI). The CCI is a novel metric of postoperative morbidity, integrating in a single formula all complications by severity, ranging from the best possible outcome of 0 (uneventful course) to the worst possible outcome of 100 (death). This is available via an online calculation tool at: https://www.assessurgery.com/about_cci-calculator/
Measured: 28 weeks
Post-operative 30 day complications using the International Study Group for Liver Surgery (ISGLS) complications score
Post-operative 30 day complications as routinely measured during standard care using the International Study Group for Liver Surgery (ISGLS) complications score. This score classifies post-hepatectomy liver failure (PHLF) into three grades of severity- A, B and C. Grade A is the least severe complication with no symptoms and requiring no treatment, and Grade C is the most sever complication involving multisystem organ failure requiring invasive treatment on the intensive care unit.
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start22 Oct 2018
- Primary completionFeb 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- The Christie NHS Foundation Trust, Manchester University NHS Foundation Trust, National Institute for Health Research, United Kingdom, National Health Service, United Kingdom, Humedics GmbH
- Responsible party
- Principal investigator, Kat Parmar, University of Manchester
- Investigators
- Prof A G Renehan, PhD FRCS, Study director, The Christie NHS Foundation Trust, The University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562234
- Sponsor's protocol ID
- MD189
- Acronym
- CLiFF
- Status last verified
- Nov 2018
- First submitted
- 22 May 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parmar KL, O'Reilly D, Valle JW, Braun M, Naish JH, Williams SR, Lloyd WK, Malcomson L, Cresswell K, Bamford C, Renehan AG. Prospective study of change in liver function and fat in patients with colorectal liver metastases undergoing preoperative chemotherapy: protocol for the CLiFF Study. BMJ Open. 2020 Sep 23;10(9):e027630. doi: 10.1136/bmjopen-2018-027630.
PubMed 32967864
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CLiFF Study: A Prospective Evaluation of Change in Liver Function and Fat in Patients With Colorectal Liver Metastases Undergoing Pre-operative Chemotherapy
- ClinicalTrials.gov ID
- NCT03562234
- Acronym / sponsor ID
- CLiFF / MD189
- Keywords
- Colorectal Cancer, Colorectal Liver Metastases, Obesity Related Cancer, Chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- The Christie NHS Foundation Trust, Manchester University NHS Foundation Trust, National Institute for Health Research, United Kingdom, National Health Service, United Kingdom, Humedics GmbH
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 19 Jun 2018 (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.
The CLiFF Study will assess changes in liver function and liver fat in patients with colorectal liver metastases (CLM) undergoing pre-operative chemotherapy before liver resection. There will be no change to the standard treatment for CLM. The change in liver fat will be assessed using novel magnetic resonance techniques and the change in liver function will be measured using a newly-developed fully-licensed breath test to give the most accurate measure of liver function possible.
Understanding if these changes are related or reversible will help to understand the relationship between obesity and cancer. This is an important issue, as obesity is now the second most common cause of cancer worldwide.
Detailed description
Obesity is the second most common cause of cancer in the United Kingdom (UK) and bowel cancer is the third most common cancer. Obesity can increase both the chance of developing bowel cancer and it's progression. Increased liver fat is likely to be important in this process, but it is not easy to measure liver fat accurately without invasive biopsies.
Chemotherapy is often used to treat colorectal liver metastases before surgery. It is known that chemotherapy can increase liver fat and can reduce liver function, however it is not known if these changes are either reversible or related.
Understanding the relationship of these changes and their potential reversibility could help plan the best treatment for colorectal liver metastases and to understand the wider relationship between obesity and cancer.
A Manchester cancer research team have developed new MR (magnetic resonance) scan techniques which are better able to measure liver fat levels without needing invasive biopsies. The researchers also have a newly-developed fully-licensed machine which can measure liver function more accurately by using a breath test (LiMAx test), donated to the team for this study by the manufacturer, Humedics GmbH.
Patients undergoing pre-operative chemotherapy for CLM at the Christie Hospital will be invited to join this study. Their liver fat content will be measured using the new MR techniques and their liver function measured using the LiMAx test. These will be measured before chemotherapy, during chemotherapy, and after they finish. Their normal treatment will remain unchanged. When they undergo liver surgery, the section of removed liver will be analysed for fatty changes to help confirm that the MR scans are accurate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-op Chemotherapy for CLM: MR & LiMAx | – | Diagnostic Test: MR, Diagnostic Test: LiMAxPatients undergoing pre-operative chemotherapy for colorectal liver metastases being treated at the Christie NHS (National Health Service) Foundation Trust. No intervention - participants will continue with standard care. Observation of changes in liver fat and liver function measured by MR (Magnetic Resonance) scan and LiMAx test (Maximum liver capacity). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with documented resectable or potentially resectable colorectal cancer liver metastases planned to undergo pre-operative standard care chemotherapy at the Christie NHS Foundation Trust,
Key inclusion criteria (8 listed)
- Histologically verified adenocarcinoma of the colon or rectum with radiological evidence of potentially resectable liver metastases, with no evidence of unresectable non-hepatic metastatic disease.
- Pre-operative chemotherapy planned using Oxaliplatin-based chemotherapy regimen (including FOLFOX, XELOX and OXCAP regimens
- Age greater than or equal to 18 years
- WHO (World Health Organisation) performance status 0, 1 or 2
- Adequate haematological and hepatic function defined by: Hb ³ 10g/dl, WBC ³ 3.0 x 109/L, ANC ³ 1.5 x 109/L, platelet count ³ 100,000/ mm3, total bilirubin < 30 mmol/L, serum AST, ALT and alkaline phosphatase 5 x upper limit of normal
Key exclusion criteria (5 listed)
- Presence of a medical or psychiatric condition that impairs their ability to give informed consent
- Presence of any other serious uncontrolled medical conditions
- Evidence of unresectable non-hepatic metastatic disease
- Pregnant or lactating women. Adequate contraception must be used in fertile patients
- Contra-indications to MR scanning
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 |
|---|---|---|
| MRLiver fat (measured as a percentage - hepatic fat fraction) will be measured by Magnetic Resonance imaging | Diagnostic test | Pre-op Chemotherapy for CLM: MR & LiMAx |
| LiMAxLiver function will be measured using the relatively new CE licenced non-invasive LiMAx (Liver Maximum Capacity) test device, manufactured by Humedics GmbH | Diagnostic test | Pre-op Chemotherapy for CLM: MR & LiMAx |
Primary outcome
Change in liver fat (hepatic fat fraction)
Time frame: 21 weeks
Change in liver fat (measured as a percentage using MR imaging - the hepatic fat fraction) comparing the baseline pre-chemotherapy measurement at Week 1 with measurements at cessation of chemotherapy (Week 13) and 8 weeks after cessation of chemotherapy (Week 21). The expectation based on relevant literature is that chemotherapy will lead to potentially reversible higher levels of liver fat. Therefore the liver fat measurement (hepatic fat fraction) should be higher at week 13 than at week 1, and if this change is reversible, the liver fat should decrease during the eight weeks following cessation of chemotherapy, resulting in the measurement at Week 21 being lower than week 13.
Change in liver function
Time frame: 21 weeks
Change in liver function measured by LiMAx test (Liver Maximum Capacity), comparing the baseline pre-chemotherapy measurement at week 1 with a measurement mid-chemotherapy (week 7), a measurement at cessation of chemotherapy (Week 13) and a measurement 8 weeks after cessation of chemotherapy (week 21). The expectation from relevant literature is that chemotherapy should cause a reversible deterioration in liver function, therefore the measurement at Week 7 should be lower than week 1, with the measurement at Week 13 then being lower again than week 7. If this deterioration in liver function is reversible, potentially within 8 weeks of stopping chemotherapy as suggested in the literature, then the measurement at Week 21 should be higher than both week 7 and week 13.
11 secondary outcomes
Change in liver enzymes
Time frame: 28 weeks
Change in body mass index (BMI)
Time frame: 21 weeks
Change in CT-derived anthropometric measurements 1 - Visceral Adipose Tissue (VAT)
Time frame: 21 weeks
Change in CT-derived anthropometric measurements 2 - Subcutaneous Adipose Tissue (SAT)
Time frame: 21 weeks
Change in CT-derived anthropometric measurements 3 - Muscle Mass
Time frame: 21 weeks
Digital histological quantification of hepatic fat
Time frame: 28 weeks
NAS-CRN grade of steatosis (Non-Alcoholic Steatohepatitis Activity Score Clinical Research Network)
Time frame: 28 weeks
Post-operative 30 day mortality
Time frame: 28 weeks
Post-operative 30 day complications using Clavien-Dindo classification
Time frame: 28 weeks
Post-operative 30 day complications using the Comprehensive Complication Index (CCI)
Time frame: 28 weeks
Post-operative 30 day complications using the International Study Group for Liver Surgery (ISGLS) complications score
Time frame: 28 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Derived from this study: PubMed 32967864Parmar KL, O'Reilly D, Valle JW, Braun M, Naish JH, Williams SR, Lloyd WK, Malcomson L, Cresswell K, Bamford C, Renehan AG. Prospective study of change in liver function and fat in patients with colorectal liver metastases undergoing preoperative chemotherapy: protocol for the CLiFF Study. BMJ Open. 2020 Sep 23;10(9):e027630. doi: 10.1136/bmjopen-2018-027630.
- 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.
Prof A G Renehan, PhD FRCS study director
The Christie NHS Foundation Trust, The University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Liver Metastasis Colon Cancer, run by University of Manchester at 1 site 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 8 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 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Kat L Parmar, MBChB FRCS (07817296021, Kat.Parmar@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in liver fat (hepatic fat fraction) (time frame: 21 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03562234, which also lists 1 linked publication.
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 7 Nov 2018.