Testing Glucose Measurements via Blood Draw for pancreatic cancer
Official title: Monitoring and Managing Glucose Levels in People With Pancreatic Cancer
Pancreatic Cancer Glucose Assessment and Regulation Study
- 1 group
- Sites in Vancouver and Toronto
- Recruiting
Interventions
- Medical procedure
Glucose Measurements via Blood Draw
Blood glucose levels will be measured using blood drawn prior to each cycle of systemic therapy. Anti-cancer treatment can follow standard care protocols or be given within another clinical trial. Anti-hyperglycemic treatment will be administered when indicated by and following standard care protocols.
Canadian Sites (2)
2 of 2 recruiting
- Recruiting
British Columbia Cancer
Vancouver, British Columbia
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario
Eligibility Criteria
See who this study is looking for28 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- +Histological/cytological diagnosis of pancreatic ductal adenocarcinoma (PDAC).
- +Planned to undergo first-line systemic therapy.
- +Age greater than or equal to 18 years.
- +Adequate bone marrow and organ function as defined by the following laboratory values:
- +Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10\^9/L.
- +Platelet count greater than or equal to 75 x 10\^9/L.
- +Hemoglobin greater than or equal to 9.0 g/dL.
- +Estimated glomerular filtration rate (GFR) by Cockroft-Gault equation OR 24 hour urine collection greater than or equal to 40 ml/min.
- +Creatinine clearance greater than or equal to 40 mL/min using Cockcroft-Gault formula.
- +Potassium within normal limits, or corrected with supplements.
- +International normalized ratio (INR) less than or equal to 1.5.
- +Total serum bilirubin less than or equal to 2 x upper limit of normal (ULN) (any elevated bilirubin should be asymptomatic at enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →) except for participants with documented Gilbert's syndrome who may only be included if the total bilirubin less than or equal to 3 x ULN or direct bilirubin less than or equal to 1.5 x ULN).
- +Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 x ULN (or less than or equal to 5 x ULN if liver metastases are present).
- +Able to understand and voluntarily sign the informed consent formInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +Able to comply with the study visit schedule and other protocolProtocolThe detailed plan a study must follow.Read more → requirements.
- +Able to swallow oral medications.
- +Measurable or evaluable disease by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 at baselineBaselineYour starting measurements, taken before treatment begins.Read more →.
- +Life expectancy of more than 90 days as judged by the study doctorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
Exclusion
- −Presence of brain metastases.
- −Absence of distant or lymph node metastases. Participants with borderline resectable or locally advanced PDAC are not eligible.
- −Known diagnosis of type I diabetes where strict glucose controlControl groupThe group a new treatment is measured against.Read more → and close Endocrinology follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → is already indicated.
- −Known diagnosis of type II diabetes and already followed by Endocrinologist.
- −Participants who are not safe to include in the study as judged by the study doctorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → for any medical or non-medical reason.
- −Unable to comply with study assessments and follow-up.
- −Participants with a positive pregnancy test.
- −Received prior systemic therapy (chemotherapy or any other anti-cancer agent) for treatment of metastatic PDAC. Participants who received adjuvant chemotherapy after surgical resection of early stage disease are eligible.
- −Currently receiving anti-cancer therapy (chemotherapy or any other anti-cancer agent).
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives Glucose Measurements via Blood Draw.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 50 people.
The study is currently expected to finish around October 2028.
The main measurement is taken over: From baselineBaselineYour starting measurements, taken before treatment begins.Read more → (up to 2 weeks prior to first dose) until progression of disease, assessed up to 24 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Proportion of participants who experience at least one episode of hyperglycemia — measured over From baselineBaselineYour starting measurements, taken before treatment begins.Read more → (up to 2 weeks prior to first dose) until progression of disease, assessed up to 24 months.
Percentage of glucose measurements above the target range — measured over From baseline (up to 2 weeks prior to first dose) until progression of disease, assessed up to 24 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05132244 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Glucose Measurements via Blood DrawProcedure
Blood glucose levels will be measured using blood drawn prior to each cycle of systemic therapy. Anti-cancer treatment can follow standard care protocols or be given within another clinical trial. Anti-hyperglycemic treatment will be administered when indicated by and following standard care protocols.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From baselineBaselineYour starting measurements, taken before treatment begins.Read more → (up to 2 weeks prior to first dose) until progression of disease, assessed up to 24 months..
The study as a whole is currently expected to finish around 2028-10.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 50 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Vancouver, British Columbia, Canada; Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This study will investigate the prevalence of hyperglycemia (high blood sugar) in approximately 50 participants with pancreatic cancer. Sugar levels will be monitored with blood draws prior to each cycle of anti-cancer treatment until treatment ends or the participant's cancer worsens. Participants may receive any first-line systemic therapy for pancreatic cancer, including treatments given as part of another clinical trial. If treatment is needed to manage blood sugar levels, the treatment will be given according to the standard of care. All participants will be enrolled into the same group.
If this study interests you
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Save it to your Collection
Keep it with the other studies you are looking at.
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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.