BridgeMD
New treatment option for Pancreatic Ductal Adenocarcinoma
Official title Using Tumour DNA and Proteins to Better Understand How Pancreatic Cancer Responds to Treatment
ClinicalTrials.gov ID: NCT06574620
What this study is testing
What is Genetic testing?
Genetic testing is an investigational medicine, being studied as a potential treatment for pancreatic ductal adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this study is to learn if the genetic information and proteins from tumours can help treat pancreatic ductal adenocarcinoma (PDAC). The main questions it aims to answer are: Is it feasible to obtain genetic test results within a timeframe that can help inform treatment decisions for individuals with PDAC?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must meet all of the following criteria prior to Pre-Baseline registration:
- Age 18 years or older.
- Histological or radiological diagnosis of resectable, borderline resectable, or locally advanced PDAC.
- Medically fit and planned to undergo laparoscopic procedure as part of standard of care.
- Able to give informed consent for the study-related procedures performed during laparoscopy. Participants must meet all of the following criteria to...
You likely can't join if
- Presence of distant or lymph node metastases. Individuals with metastatic PDAC are not eligible.
- Currently receiving adjuvant (Resectable and Borderline Resectable Cohorts) or systemic (Locally Advanced Cohort) anti-cancer therapy (chemotherapy...
- Not fit for chemotherapy as judged by the investigator.
- Presence of brain metastases.
- Positive pregnancy test.
- Unable to comply with the study assessments and procedures defined in this protocol.
See the full eligibility criteria
- Participants must meet all of the following criteria prior to Pre-Baseline registration:
- Age 18 years or older.
- Histological or radiological diagnosis of resectable, borderline resectable, or locally advanced PDAC.
- Medically fit and planned to undergo laparoscopic procedure as part of standard of care.
- Able to give informed consent for the study-related procedures performed during laparoscopy. Participants must meet all of the following criteria to be eligible for enrollment in the Main Study:
- Age 18 years or older.
- Enrolled in the Personalized Oncogenomics (POG) Program at BC Cancer.
- Histological and/or radiological diagnosis of resectable, borderline resectable, or locally advanced PDAC. Participants without a histological diagnosis of PDAC must undergo confirmatory histological diagnosis prior to...
- Medically fit to undergo surgical resection of the primary lesion(s) as judged by the investigator (Resectable and Borderline Resectable Cohorts only).
- Planned for adjuvant (Resectable and Borderline Resectable Cohorts) or first-line (Locally Advanced Cohort) therapy with FOLFIRINOX or a gemcitabine-based regimen, either as part of routine care or in combination with...
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Adequate organ function as defined by the following laboratory results obtained within 28 days prior to enrollment date:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L.
- Hemoglobin ≥ 9 g/dL.
- Platelets ≥ 75 x 10\^9/L.
- Prothrombin time test and international normalized ratio (PT/INR) and partial thromboplastin time (PTT) ≤ 1.5 x Upper Limit of Normal (ULN).
- Total bilirubin ≤ 1.5 x ULN. Isolated bilirubin \> 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%.
- Aspartate aminotransferase (AST) and alanine aminotransferase (AST) ≤ 1.5 x ULN. If liver metastases are present, AST and ALT ≤ 5 x ULN is permitted.
- Albumin ≥ 25 g/L.
- One of the following:
- Creatinine ≤ 1.5 x ULN.
- Calculated creatinine clearance (as calculated by Cockcroft-Gault formula) ≥ 40 mL/min.
- 24-hour urine creatinine clearance ≥ 40 mL/min.
- Life expectancy greater than 90 days as judged by the investigator.
- Able to give informed consent for the study procedures defined in this protocol.
- Measurable disease by RECIST 1.1. For those in the Resectable and Borderline Resectable Cohorts, measurable disease must be present prior to resection surgery.
- Presence of distant or lymph node metastases. Individuals with metastatic PDAC are not eligible.
- Currently receiving adjuvant (Resectable and Borderline Resectable Cohorts) or systemic (Locally Advanced Cohort) anti-cancer therapy (chemotherapy or any other anti-cancer agent) with one exception: pre-operative...
- Not fit for chemotherapy as judged by the investigator.
- Presence of brain metastases.
- Positive pregnancy test.
- Unable to comply with the study assessments and procedures defined in this protocol.
- Individuals who are otherwise judged by the investigator to be unfit to proceed with this protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.