Study of the Safety, Tolerability and Efficacy of Metabolic Combination Treatments on Cancer (METRICS)
|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: NCT02201381|
Recruitment Status : Not yet recruiting
First Posted : July 28, 2014
Last Update Posted : April 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cancer Overall Survival||Drug: Metabolic treatment||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||207 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Matched historical control comparison|
|Masking:||None (Open Label)|
|Official Title:||A Non Randomised, Non Blinded Real World Trial of the Safety, Tolerability and Effectiveness of Metabolic Medicines for the Treatment of Cancer Compared Against Matched Controls|
|Estimated Study Start Date :||June 22, 2020|
|Estimated Primary Completion Date :||June 22, 2025|
|Estimated Study Completion Date :||October 22, 2026|
Experimental: Metabolic Treatment
Subjects will take the following treatments and have their data collected from their medical records every 3 months.
Drug: Metabolic treatment
While subjects are being treated with the four metabolic drugs, every 3 months they will bring in their medical records and data will be collected to determine the effect of the intervention
- Overall survival [ Time Frame: up to 5 years ]Overall survival for all cancer types and for each cancer type (years and months)
- Change in primary tumour size cancer types and by cancer type. [ Time Frame: up to 5 years ]Tumour size for all cancer types and for each cancer type. Units of size vary depending on cancer type.
- Change in tumour spread (metastasis) [ Time Frame: up to 5 years ]Tumour spread (metastasized) to other tissues/organs, for all cancer types and for each cancer type. This is measured as either 0 for no spread or 1 for confirmed spread.
- Change in tumour number [ Time Frame: up to 5 years ]Tumour number for all cancer types and for each cancer type
- Change in cancer biomarkers (blood, urine or biopsy) [ Time Frame: up to 5 years ]Cancer biomarkers for all cancer types and for each cancer type. Units of measurement vary depending on the cancer type. When biomarkers, either alone or in combination with other biomarkers, are raised above normal they are seen as predictive of cancer of progression. If returned to normal are indicative of treatment response.
- Incidence of treatment related adverse events [ Time Frame: 5 years ]
Adverse events reported by the subject or their HCP.
• Quarterly assessment of routine laboratory tests
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): NCT02201381
|Contact: Robin Bannister, PhD||+44 207 153 email@example.com|
|Contact: Gregory Stoloff||+44 207 580 firstname.lastname@example.org|
|Principal Investigator:||Samir Agrawal, MRCP FRCPath||Care Oncology Clinic|