ClinicalTrials.gg
RecruitingNCT05132244PEGASUSUpdated Sep 14, 2026

Monitoring and Managing Glucose Levels in People With Pancreatic Cancer

An interventional study of Glucose Measurements via Blood Draw in Pancreatic Cancer, PDAC - Pancreatic Ductal Adenocarcinoma and Hyperglycemia, sponsored by British Columbia Cancer Agency. Recruiting at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by British Columbia Cancer Agency · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Pancreatic Cancer
  • PDAC - Pancreatic Ductal Adenocarcinoma
  • Hyperglycemia

Keywords

  • Glycemic management
  • Prevalence of hyperglycemia
  • Blood draws
  • Standard treatments
  • First-line systemic therapy
03

In context

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.

This study's planned enrollment of 50 is close to the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

British Columbia Cancer Agency is the lead sponsor of 152 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Histological/cytological diagnosis of pancreatic ductal adenocarcinoma (PDAC).
  • Planned to undergo systemic therapy.
  • Age greater than or equal to 18 years.
  • (ECOG) performance status 0-1.
  • Adequate bone marrow and organ function as defined by the following laboratory values:

    1. (ANC) greater than or equal to 1.5 x 10\^9/L.
    2. count greater than or equal to 75 x 10\^9/L.
    3. greater than or equal to 9.0 g/dL.
    4. Estimated (GFR) by Cockroft-Gault equation OR 24 hour urine collection greater than or equal to 40 ml/min.
    5. greater than or equal to 40 mL/min using Cockcroft-Gault formula.
    6. Potassium within normal limits, or corrected with supplements.
    7. (INR) less than or equal to 1.5.
    8. Total serum less than or equal to 2 x (ULN) (any elevated bilirubin should be asymptomatic at enrollment) 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).
    9. (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 are present).
  • Able to understand and voluntarily sign the form.
  • Able to comply with the study visit schedule and other protocol requirements.
  • Able to swallow oral medications.
  • Measurable or evaluable disease by (RECIST) 1.1 at baseline.
  • of more than 90 days as judged by the study doctor.

Exclusion criteria

Exclusion Criteria:

  • Absence of distant or lymph node . Participants with borderline resectable or locally advanced PDAC are not eligible.
  • Received prior systemic therapy (chemotherapy or any other anti-cancer agent) for treatment of metastatic PDAC. Participants who received chemotherapy after surgical resection of early stage disease are eligible.
  • Currently receiving anti-cancer therapy (chemotherapy or any other anti-cancer agent).
  • Presence of .
  • Known diagnosis of type I diabetes where strict glucose control and close Endocrinology follow-up is already indicated.
  • Known diagnosis of type II diabetes and already followed by Endocrinologist.
  • Participants with a positive pregnancy test.
  • Participants who are not safe to include in the study as judged by the study doctor for any medical or non-medical reason.
  • Unable to comply with study assessments and follow-up.
Terms in these criteria, in plain language(17)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Glucose Measurements via Blood Draws

    Participants will have glucose levels measured using blood drawn prior to each cycle of systemic therapy.

    Procedure: Glucose Measurements via Blood Draw

Interventions

  • ProcedureGlucose 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.

06

What researchers measure

Primary outcomes

  1. Proportion of participants who experience at least one episode of hyperglycemia

    The proportion of participants who experience at least one episode of hyperglycemia. Hyperglycemia is defined by standard non-fasting criteria: random plasma glucose greater than or equal to 11.1 mmol/L or hemoglobin A1c greater than or equal to 6.5%.

    Time frame: From baseline (up to 2 weeks prior to first dose) until progression of disease, assessed up to 24 months.

  2. Percentage of glucose measurements above the target range

    The percentage of random plasma glucose measurements that are greater than or equal to 11.1 mmol/L or hemoglobin A1c measurements that are greater than or equal to 6.5%.

    Time frame: From baseline (up to 2 weeks prior to first dose) until progression of disease, assessed up to 24 months.

Secondary outcomes

  1. Overall response rate (ORR) of the cohort, as defined by RECIST 1.1

    The proportion of participants who have a complete response (CR) or partial response (PR) to first-line systemic therapy, as defined by RECIST 1.1.

    Time frame: From the date of the screening scan (within 28 days of first dose) until the date of confirmed progression, assessed up to 24 months.

  2. Progression-free survival (PFS) of the cohort from the initiation of first-line systemic therapy

    The length of time from the first dose of first-line systemic therapy until the date of progressive disease (PD), as defined by RECIST 1.1.

    Time frame: From the date of first dose of first-line systemic therapy until the date of confirmed progression, assessed up to 24 months.

  3. Overall survival (OS) of the cohort from the initiation of first-line systemic therapy

    The length of time from the initiation of first-line systemic therapy that participants survive.

    Time frame: From the date of first dose of first-line systemic therapy until the date of death or end of study, assessed up to 24 months.

Other outcomes

  1. Overall response rate (ORR) of the cohort, as defined by RECIST 1.1 and stratified by prognostic and metabolic gene expression subtypes of PDAC

    The proportion of participants stratified by prognostic and metabolic gene expression subtypes of PDAC who have a complete response (CR) or partial response (PR) to first-line systemic therapy, as defined by RECIST 1.1.

    Time frame: From the date of the screening scan (within 28 days of first dose) until the date of confirmed progression, assessed up to 24 months.

  2. Progression-free survival (PFS) of the cohort stratified by prognostic and metabolic gene expression subtypes of PDAC from the initiation of first-line systemic therapy

    The length of time from the first dose of first-line systemic therapy until the date of progressive disease (PD), as defined by RECIST 1.1, for participants stratified by prognostic and metabolic gene expression subtypes of PDAC.

    Time frame: From the date of first dose of first-line systemic therapy until the date of confirmed progression, assessed up to 24 months.

  3. Overall survival (OS) of the cohort stratified by prognostic and metabolic gene expression subtypes of PDAC from the initiation of first-line systemic therapy

    The length of time from the initiation of first-line systemic therapy that participants survive stratified by prognostic and metabolic gene expression subtypes of PDAC.

    Time frame: From the date of first dose of first-line systemic therapy until the date of death or end of study, assessed up to 24 months.

  4. Overall response rate (ORR) of the cohort, as defined by RECIST 1.1 and stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles

    The proportion of participants stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles who have a complete response (CR) or partial response (PR) to first-line systemic therapy, as defined by RECIST 1.1.

    Time frame: From the date of the screening scan (within 28 days of first dose) until the date of confirmed progression, assessed up to 24 months.

  5. Progression-free survival (PFS) of the cohort, stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles from the initiation of first-line systemic therapy

    The length of time from the first dose of first-line systemic therapy until the date of progressive disease (PD), as defined by RECIST 1.1, for participants stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles.

    Time frame: From the date of first dose of first-line systemic therapy until the date of confirmed progression, assessed up to 24 months.

  6. Overall survival (OS) of the cohort stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles from the initiation of first-line systemic therapy

    The length of time from the initiation of first-line systemic therapy that participants survive stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles.

    Time frame: From the date of first dose of first-line systemic therapy until the date of death or end of study, assessed up to 24 months.

  7. Amount of insulin, measured in molar, for participants from screening until the end of study visit

    The quantity of insulin, measured in molar from immunoassays, from blood samples collected throughout the study.

    Time frame: From the date of screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).

  8. Amount of proinsulin, measured in molar, for participants from screening until the end of study visit

    The quantity of proinsulin, measured in molar from immunoassays, from blood samples collected throughout the study.

    Time frame: From the date of the screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).

  9. Amount of C-peptide, measured in molar, for participants from screening until the end of study visit

    The quantity of C-peptide, measured in molar from immunoassays, from blood samples collected throughout the study.

    Time frame: From the date of the screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).

  10. Amount of circulating biomarkers, measured in molar, for participants from screening until the end of study visit

    The quantity of circulating biomarkers, measured in molar from immunoassays, from blood samples collected throughout the study.

    Time frame: From the date of the screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).

07

Study locations

2 of 2 sites recruiting
  • British Columbia Cancer
    Vancouver, British Columbia V5Z 4E6, Canada
    Recruiting
    • Daniel Renouf, MD, MPH · Contactdrenouf@bccancer.bc.ca · 800-663-3333
    • Daniel Renouf, MD, MPH · Principal investigator
  • Princess Margaret Cancer Centre
    Toronto, Ontario M5G 2M9, Canada
    Recruiting
08

References and documents

Publications

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  • Pleasance E, Titmuss E, Williamson L, Kwan H, Culibrk L, Zhao EY, Dixon K, Fan K, Bowlby R, Jones MR, Shen Y, Grewal JK, Ashkani J, Wee K, Grisdale CJ, Thibodeau ML, Bozoky Z, Pearson H, Majounie E, Vira T, Shenwai R, Mungall KL, Chuah E, Davies A, Warren M, Reisle C, Bonakdar M, Taylor GA, Csizmok V, Chan SK, Zong Z, Bilobram S, Muhammadzadeh A, D'Souza D, Corbett RD, MacMillan D, Carreira M, Choo C, Bleile D, Sadeghi S, Zhang W, Wong T, Cheng D, Brown SD, Holt RA, Moore RA, Mungall AJ, Zhao Y, Nelson J, Fok A, Ma Y, Lee MKC, Lavoie JM, Mendis S, Karasinska JM, Deol B, Fisic A, Schaeffer DF, Yip S, Schrader K, Regier DA, Weymann D, Chia S, Gelmon K, Tinker A, Sun S, Lim H, Renouf DJ, Laskin J, Jones SJM, Marra MA. Pan-cancer analysis of advanced patient tumors reveals interactions between therapy and genomic landscapes. Nat Cancer. 2020 Apr;1(4):452-468. doi: 10.1038/s43018-020-0050-6. Epub 2020 Apr 13. PubMed 35121966 ↗
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  • Yuan C, Rubinson DA, Qian ZR, Wu C, Kraft P, Bao Y, Ogino S, Ng K, Clancy TE, Swanson RS, Gorman MJ, Brais LK, Li T, Stampfer MJ, Hu FB, Giovannucci EL, Kulke MH, Fuchs CS, Wolpin BM. Survival among patients with pancreatic cancer and long-standing or recent-onset diabetes mellitus. J Clin Oncol. 2015 Jan 1;33(1):29-35. doi: 10.1200/JCO.2014.57.5688. Epub 2014 Nov 17. PubMed 25403204 ↗
  • Zhang AMY, Magrill J, de Winter TJJ, Hu X, Skovso S, Schaeffer DF, Kopp JL, Johnson JD. Endogenous Hyperinsulinemia Contributes to Pancreatic Cancer Development. Cell Metab. 2019 Sep 3;30(3):403-404. doi: 10.1016/j.cmet.2019.07.003. Epub 2019 Aug 1. No abstract available. PubMed 31378465 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05132244
Responsible party
Sponsor
First posted
Nov 24, 2021
Start date
Apr 16, 2024
Primary completion
Oct 2028 (estimated)
Completion
Oct 2028 (estimated)
Last update
Sep 14, 2026

Study contacts

Daniel Renouf, MD, MPH
Contact
drenouf@bccancer.bc.ca
800-663-3333
Daniel Renouf, MD, MPH
principal investigator · BC Cancer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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