Clinical trial · Observational
Prospectively Defining Metastatic Pancreatic Ductal Adenocarcinoma Subtypes by Comprehensive Genomic Analysis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
Researchers are looking for better ways of understanding and treating pancreatic cancer. The purpose of this study is to see how useful it is to look for changes and characteristics in your genes (molecules that contain instructions for the development and functioning of the cells) and the genes within the tumour. These characteristics may be useful in choosing treatments for patients in the future. Changes (mutations) in genes have been shown to be an important characteristic in cancers. Looking at differences in genes in patients with advanced pancreatic ductal adenocarcinomas and comparing this information with response to their initial chemotherapy treatment may help to learn which treatments may be better for certain patients after initial treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Serial Collection of Plasma and Serum Samples | Other | — | UNRESOLVED |
| Tumour Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Biopsy Cohort
- description
- Participants will undergo a tumour biopsy at baseline and an optional tumour biopsy at disease progression. Participants will undergo serial collection of plasma and serum samples.
- interventionNames
- Procedure: Tumour Biopsy
- Other: Serial Collection of Plasma and Serum Samples
- label
- Archival Cohort
- description
- Genomic analyses will be performed on participants' archival tumour samples. Participants will undergo serial collection of plasma and serum samples.
- interventionNames
- Other: Serial Collection of Plasma and Serum Samples
Primary outcomes (1)
- measure
- Number of days between biopsy and return of comprehensive genomic results.
- timeFrame
- An average of 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological and/or radiological diagnosis of metastatic PDAC. Patients without a histological diagnosis of PDAC must undergo confirmatory tumour biopsy prior to treatment start date. * Planned for first-line systemic therapy with FOLFIRINOX or GP, either in routine care or in combination with an investigational agent(s) within a clinical trial. * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Adequate organ function * Life expectancy of \> 90 days as judged by the investigator * Ability to give informed consent * Measurable disease by RECIST 1.1 * Presence of a tumour lesion amenable to core needle biopsy as judged by a staff interventional radiologist. A minimum of 3 tumour cores must be safely obtainable under CT or US guidance. * Fit enough to safely undergo a tumour biopsy as judged by the investigator * Ability to lie supine for \> 60 minutes Patients in the archival cohort must also fulfil the following criteria: * Archival tumour sample available (either a previous tumour diagnostic biopsy or resection specimen) Exclusion Criteria: * Absence of distant or lymph node metastases. Patients with borderline resectable or locally advanced PDAC are not eligible. * Received prior systemic therapy (chemotherapy or any other anti-cancer agent) in the advanced setting. Patients 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) * Not fit for combination chemotherapy as judged by the investigator * Presence of brain metastases * Female patients with positive pregnancy test * Patients who are not safe to include in the study as judged by the investigator for any medical or non-medical reason * Unable to comply with study assessments and follow-up
References
Publications (38)
- BACKGROUNDHurton S, MacDonald F, Porter G, Walsh M, Molinari M. The current state of pancreatic cancer in Canada: incidence, mortality, and surgical therapy. Pancreas. 2014 Aug;43(6):879-85. doi: 10.1097/MPA.0000000000000147. PMID 24763076
- BACKGROUNDCanadian Cancer Society's Advisory Committee on Cancer Statistics. Canadian Cancer Statistics 2015. Toronto, ON: Canadian Cancer Society; 2015.
- BACKGROUNDSener SF, Fremgen A, Menck HR, Winchester DP. Pancreatic cancer: a report of treatment and survival trends for 100,313 patients diagnosed from 1985-1995, using the National Cancer Database. J Am Coll Surg. 1999 Jul;189(1):1-7. doi: 10.1016/s1072-7515(99)00075-7. PMID 10401733
- BACKGROUNDGarcea G, Dennison AR, Pattenden CJ, Neal CP, Sutton CD, Berry DP. Survival following curative resection for pancreatic ductal adenocarcinoma. A systematic review of the literature. JOP. 2008 Mar 8;9(2):99-132. PMID 18326920
- BACKGROUNDRothenberg ML, Moore MJ, Cripps MC, Andersen JS, Portenoy RK, Burris HA 3rd, Green MR, Tarassoff PG, Brown TD, Casper ES, Storniolo AM, Von Hoff DD. A phase II trial of gemcitabine in patients with 5-FU-refractory pancreas cancer. Ann Oncol. 1996 Apr;7(4):347-53. doi: 10.1093/oxfordjournals.annonc.a010600. PMID 8805925
- BACKGROUNDGlimelius B, Hoffman K, Sjoden PO, Jacobsson G, Sellstrom H, Enander LK, Linne T, Svensson C. Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol. 1996 Aug;7(6):593-600. doi: 10.1093/oxfordjournals.annonc.a010676. PMID 8879373
- BACKGROUNDConroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.