Pancreatic Ductal Adenocarcinoma study: Genetic testing
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 study wants to see if genetic and protein information from tumors can be obtained quickly enough to help choose treatments and predict how the cancer will respond.
- Who it's for
- People diagnosed with pancreatic ductal adenocarcinoma, including resectable, borderline resectable, or locally advanced cases.
- What's involved
- Participants will receive standard chemotherapy, give blood, tissue, and fluid samples for testing, attend clinic visits every 4 weeks, and fill out questionnaires every 12 weeks.
- Time commitment
- The study lasts as long as the chemotherapy regimen, with clinic visits every month and questionnaires every three months.
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
- 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.
- Age 18 years or older.
- Enrolled in the Personalized Oncogenomics (POG) Program at BC Cancer.
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
- 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.
- 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.
- 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.
- 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.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Vancouver, British Columbia, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.